Engagement Manager – Life Sciences Strategy

 

Heading Engagement Manager – Life Sciences Strategy
Category

San Francisco, Boston or NYC

 
Description
Engagement Managers are responsible for leading workstreams and engagements, translating client needs into project tasks and deliverables. Engagement Managers manage day-to-day problem-solving and team analytical activities, and serve as key liaisons between consulting team members, VPs and Partners, and our clients. Senior Consultants are also responsible for mentoring and developing team staff. Our teams work on a variety of client issues. The range of assignments includes developing long-term strategies for organizations, evaluating the potential acquisition of businesses, improving educational achievement outcomes, developing new marketing channel strategies, reducing operating costs, and evaluating new business ventures. Responsibilities: Develop business strategies using tools such as market analysis, customer research, macroeconomic forecasting, and portfolio optimization. Review transaction rationale and/or deal documents to identify critical business issues and risks relating to a proposed transaction. Assist in defining the objective and scope of strategy engagements and client deliverables in consultation with the Vice President and Managing Director Manage workstreams/projects from initial data collection and analysis to creating final client deliverables Effectively manage and motivate workstreams and teams with diverse skills and backgrounds Develop and maintain relationships with clients Develop, manage and mentor junior team members at the Associate, Senior Associate, and Consultant levels. Qualifications: Preferably, an MBA with two years of related work experience or graduate degree with at least three years of related work experience, with a particular focus on client advisory or strategic planning within a professional services environment. At a minimum, a bachelor’s degree in a life sciences discipline with outstanding academic performance and at least 5 years of related work experience. Experience managing business strategy and M&A strategic diligence projects in life sciences in complex environments. Ability to make detailed assessments of industry, products, markets, competitors and customers to identify risks and opportunities in pharmaceuticals, diagnostics, device or life sciences tools. Commitment to staying at the cutting edge of knowledge in the life sciences industry. Strong aptitude for quantitative and qualitative analysis and the ability to link business strategy to performance. Excellent problem solving, project management, facilitation and interpersonal skills. Proficient in the English language, including the ability to listen, understand, read and communicate effectively, both in writing and verbally, in a professional environment. Effective organization and time management skills with ability to work under pressure and adhere to project deadlines. Able to multitask and work efficiently in a fast-paced environment. A strong work initiative, high energy level and the ability to adapt to new challenges and ideas. Willingness and ability to travel, when necessary (approximately 25-50%).

 

 

 

please email resume and covers letter to jobs@tseworldwide.com

Senior Director of Legal and Intellectual Property

Biotechnology company dedicated to transforming the treatment of devastating diseases through the intracellular delivery of biologics. Our technology enables the efficient intracellular delivery of proteins, peptides and nucleic acids, thus allowing for the development of programs across several intracellular target classes. The Company’s novel approach addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the delivery of molecules into the cytosol.

Position Summary

We are hiring for a strategically-minded and detail-oriented Director of Legal and Intellectual Property with life sciences industry experience. This individual will be responsible for building and leading the Company’s intellectual property strategy by working collaboratively with both the research organization and the business functions. The successful hire will play a central role in shaping corporate strategy, act as a trusted legal advisor within the company and have a direct and significant impact on of multiple intracellular biologics programs. 

Job Responsibilities

  • Closely partner with the R&D organization to identify, develop and execute strategies to protect the Company’s intellectual property
  • Lead the drafting and prosecution of patent applications as in-house counsel to develop global, comprehensive intellectual property portfolios
  • Manage the existing patent portfolios and closely work with relevant collaborators
  • Provide patentability, freedom-to-operate and other legal opinions and risk assessments
  • Monitor competitive intellectual property, conduct prior art searches and respond to administrative challenges by third parties
  • Support business development and other contractual processes by drafting, negotiating and reviewing key legal and intellectual property-related aspects
  • Review publications, presentations, press releases and other materials for clearance
  • Effectively manage external relationships with outside counsel
  • Effectively inform and advise senior management on corporate legal issues

Qualifications

  • 5+ years of experience acting as patent counsel on biologics, either at a biotech or pharma company and/or representing such companies at a law firm
  • J.D. and admission in good standing to the state bar
  • Advanced degree in the biological sciences
  • Admission to practice before the U.S. Patent and Trademark Office (USPTO)
  • Strategic thinker who can anticipate legal and intellectual property-related issues and formulate and execute a course of action to address such issues
  • Excellent communicator with strong interpersonal skills who will act as a trusted partner for the R&D and G&A organizations
  • Significant experience drafting and negotiating agreements and contracts
  • Significant experience working collaboratively in a cross-functional team spanning scientific, clinical business and legal
  • Ability to manage and prioritize multiple workstreams simultaneously
  • Ability to work efficiently in fast-paced, changing environments and respond effectively in challenging and ambiguous situations

email resume and cover letter to jobs@tseworldwide.com

Associate Director; M&A Analyst/Corporate Development

Summary

Corporate Development is a strategic function that encompasses strategy, portfolio management, and business development and licensing. This position will support us with evaluating business development and licensing opportunities and portfolio management-related initiatives. Working closely with the business development and licensing, commercial operations, Technical operations and R&D functions, the Senior Analyst will provide analysis and financial decision support to our various stakeholders.

The Senior Corporate Development Analyst will support the Corporate Development group in strategic investment and financial modeling and analysis, business planning, and presentation. This position will be responsible for developing forecasting analytics for various projects (in-licensing, acquisitions, pipeline assessments, process improvement) with respect to investment and return, capital budgets, and investment needs, as well as providing projected results and metrics in terms of return on investment, IRR, return on capital employed, and other relevant financial metrics.

Key Responsibilities

Prepare accurate and timely financial models and analyses in support of deals, portfolio projects, and investment opportunities under tight deadlines; create financial models incorporating research and analysis that shows leading indicators and key business projections and results.
Routinely support evaluation of business development, portfolio, and pipeline opportunities.
Help create presentations for senior management.
Manage multiple projects and competing priorities simultaneously
Develop and maintain relationships with various levels of personnel.
Engage with functional leaders to gather inputs.
Perform ad-hoc analysis and projects as required.
Assist as needed with building and maintaining dashboards and weekly/monthly reports for portfolio projects and deals under consideration.
Complete all company-based and job-related training as assigned by company within the required timeline.
Contribute to the best practices repository of the Corporate Development department.
Challenge processes and the status quo to drive improvements.

Job Requirements

BA/BS degree in Finance or equivalent. MBA and/or CPA certification preferred, not required.
Minimum years of experience: 5
Prior consulting, investment banking, corporate finance or related M&A experience-healthcare preferred.

Pharmaceutical Financial Modeling And Analysis Experience Essential.

Experience with risk adjustments as applied to investment decisions; discount rates, probability of technical and regulatory success, etc.
Demonstrate strong business acumen.
Technical expertise in finance, budgeting, and forecasting.
Knowledge of financial statement analysis and reporting.
Ability to build and maintain financial models.
Feel comfortable challenging business partners and make recommendations.
Critical thinking and problem solving skills.
Demonstrate strong attention to detail.
Must have excellent verbal communication and organizational skills.
Strong interpersonal skills including the ability to communicate effectively with individuals across all levels.
Ability to work in a fast paced, collaborative, team environment.
Commitment to quality and excellence, upholding the highest professional standards.
Effective presentation skills.
Advanced Microsoft Excel skills with the ability to provide meaningful analysis (toggles, project & deal scenarios).

qualified candidates should email resume and cover letter jobs@tseworldwide.com

Executive Director, Clinical Development

Position Summary
The Executive or Senior Director, Clinical Development  will provide medical input to Global Program Teams (GPTs), serve as medical expert for the study team and medical monitor for phase 1-4 clinical trials. The E/D is typically responsible for 1 or more medium sized clinical development programs under the supervision of the VP Clinical Development TA Head.  In addition, she/he may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target). This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

Job Duties & Responsibilities

 *   Medical input to the Global Development Team / Subteam
 *   Medical Expert for clinical study team
 *   Protocol development from concept to final protocol
 *   Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
 *   Scientific interpretation of data from clinical studies
 *   May supervise other medical monitors on individual studies
 *   Strategic guidance to phase I/II/III development programs and oversight of global clinical trials/trial team (s) on assigned programs
 *   Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
 *   Presentation at academic congresses, investigator meetings and advisory meetings
 *   Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
 *   Providing medical/scientific input to evaluate potential business opportunities

Essential Qualifications

 *   MD or equivalent; Board Certification preferred
 *   5-10 years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)
 *   Experience as a medical monitor for clinical trials required
 *   Regulatory experience preferred
 *   Publication in peer reviewed journals
 *   Excellent written / oral communication skills
 *   Attention to detail and ability to think strategically
 *   Willingness to take on new responsibilities
 *   Interest and ability to learn about new therapeutic areas
 *   Interest in career progression and ability to take on a more senior roles in 1-3 years

Preferred Qualifications

 *   Experience for medical responsibilities on a cross-functional team preferred
 *   Basic statistical knowledge preferred

please email CV and cover letter to jobs@tseworldwide.com

Sr. Vice President, Commercial (Offer Accepted)


Every immune system has a story to tell— the key is knowing how to listen. Our goal is to meaningfully improve people’s lives by learning from the wisdom of their adaptive immune systems. It’s a bold objective that we’re uniquely built to achieve.

At Adaptive, you’ll be challenged, you’ll be inspired, and you’ll be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you’ll find a diverse, team-driven, fun culture where your contributions truly count. 

Position Overview

Adaptive aims to translate the genetics of the adaptive immune system to create clinical products to improve the way in which diseases are both diagnosed and treated. Specific to diagnostics, we have a robust clinical pipeline that leverages our partnership with Microsoft executed in 2017 to use machine learning to accelerate our ability to connect receptors and antigens at scale to enable our vision of creating a blood test, called immunoSEQ Dx, for the early and accurate detection of many diseases at the same time.  

Our path to commercialization starts with an initial focus on diseases for which there is a high unmet medical need and the antigens are well-understood. To begin with, we are focused on ovarian cancer in high-risk women as a test case for oncology, celiac disease as an example for autoimmune disorders, and lyme disease as a starting point for infectious diseases. We already have two early clinical signals from celiac and lyme disease. We expect to confirm at least one of these clinical signals and initiate a clinical validation study by the end of 2019, with a path towards submission to FDA for our first indication in 2020.  

At this stage, we are looking to build a commercial organization under this leader of immunoSEQ Dx to develop the markets for the initial selected indications as well as pave a path forward for the potential for immunoSEQ Dx to fulfill a novel paradigm of being “one test with many results.” We envision a future where this map will enable a doctor to get a clear picture of what a patient’s immune system is seeing from a single blood test, and we are seeking a bold, innovative, entrepreneurial, out of the box thinker to help us to make this vision a reality.  

The Senior Vice President, Diagnostics, immunoSEQ Dx is responsible for building and leading a team of colleagues, inclusive of Sales & Marketing and other key commercial functions, to launch immunoSEQ Dx in the initial indication(s) and to work with medical and regulatory to devise a path forward for a “one test with many results” medium to longer term product positioning.  

Specifically, this innovative and results-oriented leader will also design and implement a national reimbursement strategy for public and national/regional commercial payers, they will assess the market and develop an appropriate account-based brand strategy, they will lead the team that activates and develops accounts and that ultimately generates the pull-through revenues that will help Adaptive achieve and exceed its stated goals.  

The successful candidate will have a proven record of effectively collaborating with the payer community, establishing strategic contracts for innovative healthcare products and/or services, establishing clear objectives, aligning field resources with strategic opportunities, and developing incentive programs which drive teams to success. Hands-on leadership is essential to maintaining cross-functional collaboration and motivating the team to develop new programs and resources which will drive adoption of Adaptive’s diagnostic products.   

The SVP, immunoSEQ Dx, will sit on Adaptive’s executive leadership team and will report to the President.  


Responsibilities

  • Work with medical, regulatory, market access and commercial to formalize the go-to-market strategy for immunoSEQ Dx, inclusive of the initial indication set and preparing for the validation and roll out of the longer term product vision 
  • Integrate with and continue to develop the cross-functional alliance that has been built between Adaptive and Microsoft 
  • Ensure access to clinical samples and partners to expedite the creation of the antigen map 
  • In partnership with medical, institute key partnerships with integrated delivery networks, institutions, patient and payer organizations to develop and validate immunoSEQ Dx 
  • Develop network of key opinion leaders in each of the initial indications and more broadly with medical policy influencers to launch the product and grow it into “one test with many results” 
  • Provide commercial input to comp bio and software to guide data analyses 
  • Develop and implement payer strategies 
  • Develop the market, prepare for launch, and launch immunoSEQ Dx with top-notch team of sales professionals 
  • Lead and develop infrastructure to track, monitor and report on sales performance 
  • Collaborate closely across all functions to drive adoption and ensure effective customer management  

Requirements 

Skills, Abilities and Credentials 

  • At this stage, Adaptive is seeking a bold, innovative leader of teams who can productize one of the more promising data sets in history 
  • While familiarity with genomics and laboratory services will become necessary, we are open to meeting business leaders of varying backgrounds to identify the right leadership style and cultural fit  
  • Business travel is required for internal and external business meetings  

Qualifications 

  • Bachelor’s Degree is required, MBA or other related graduate-level degree is preferred  
  • Strategic understanding of how to forecast capability requirements, build future capabilities, optimize talent and drive development 
  • Experience identifying new customer and partnership opportunities, determining optimal relationship conditions/model (licensing, co-promotion, acquisition), and executing these relationships 
  • A demonstrated history of sales effective and leadership 

To learn more or submit your resume, contact us at jobs@tseworldwide.com

Executive Director, Late Phase Medical Lead


Executive Director, Late Phase Medical Lead

Position Summary

The Executive Director , will provide global support for strategic planning and leadership in our metabolics program for Rare GI. He/She will be responsible for providing strong scientific and medical support with an in-depth understanding of the Metabolics medical landscape, particularly in the designated therapeutic areas. He/She will also support the development and implementation of the short and long-term strategy, practices and infrastructure for Global Activities, aligning with overall medical affairs strategy and effective cross-functional collaboration, namely on the development of phase IIIB/IV research, Advise seeking activities, Patient Engagement, Materials, etc. Support the Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.

Job Duties & Responsibilities

Develop and implement global medical strategy and plan for GMA activities (pre-launch and post -launch as applicable) for the Metabolics by providing medical leadership, insight and strategy to the global medical affairs team across functions and countries globally. Responsible for the following:

  • Develop in-year global medical strategy, Implementation and budget plan for global initiatives
  • Lead on the situational assessment and the global product strategy development including harmonization of activities involving KOLs.
  • Provide medical strategic recommendation for in-line life cycle management (LCM) and late phase pipeline programs
  • Development and execution of major registration LCM program and geographically expansion strategy
  • Develop Phase 3b/4 and ISR evidence generation strategy for late phase pipeline and in-line TA programs
  • Develop and oversee clinical study design (non-registration phase IIIb/IV, registries, outcomes research etc.) for late phase pipeline and in-line Metabolics programs in close collaboration with relevant functions
  • Provide medical review and ensure alignment with Metabolics strategy of Investigator sponsored research (ISR) proposals including the review of the Final Report
  • Provide clear strategic guidance to scientific communication, internal medical training, external medical education (CME, Symposia, medical education), Medical info, PEVT teams in developing functional plans supporting global medical strategy
  • Develop medically appropriate commercial strategy/tactic, planning and execution
  • Provide global medical guidance to country medical teams in developing country medical plans aligned with global medical strategy
  • Collaborate with country medical Metabolics lead to ensure local activities are aligned with global medical strategy and that Global Medical is sufficiently aware of country insights and needs. Alignment among Global and Country Medical Plans, adjust if needed.
  • Monitor team performance in terms of goals and delivery of global medical plans
  • Serves as the medical expert and resource within ALXN in support of the therapeutic area.
  • Lead content development and presentation for external medical education programs, and other Global Medical initiatives
  • Develop, conduct, or participate in therapeutic training programs for personnel.
  • Medical affairs review materials
  • Independent review of Medical Grant requests including CME, symposia and others.
  • Medical affairs review of post approval regulatory responses and annual safety reports
  • Medical affairs review of reimbursement and value dossiers
  • Medical affairs review of congress abstracts and publications
  • Establishes strategic partnerships with centers of excellence and KOLs in areas of scientific interest and serves as conduit for flow of information both out to the medical community and into the company. Responsible for the following:
  • Development and execution of Global KOL medical engagement strategy
  • Provide Metabolics KOL engagement strategy and guidance to country medical teams in developing country KOL engagement plans
  • Establish and/or enhance partnerships with key academic institutions and develop relationships with global key thought leaders
  • Planning, designing and managing global medical Advisory Boards and gather insight from regional/local medical Advisory Boards
  • Responsible for the Global and Country Quarterly Management Review and will be consulted on defining Country-Specific Medical Plan.

Essential Qualifications

  • Disease and Product Expertise (preferably with background on Neurology, Endocrinology, Hepatology or Internal Medicine)
  • Experience leading Medical Affairs function
  • Proficient in Medical Governance and operations, with extensive regulatory and compliance experience leading a Medical Affairs organization
  • Strong people management and leadership skills acquired in a multicultural environment
  • Excellent communication skills both written and verbal.
  • Ability to lead and motivate a team, both internally and remotely
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and project leader
  • Previous Clinical Operations experience (design and implementation of clinical trials)
  • Proven ability to manage budget and resources
  • Strong business acumen
  • Ability to build partnership access between HQ and affiliates
  • Flexibility and ability to adapt to changing conditions
  • Excellent problem solving, organizational, and negotiating skills
  • Must demonstrate an energy and enthusiasm which brings a positive approach to all challenges Sense of ethics and responsibility
  • Fluent in English
  • Travel required up to 25% to 35%

Preferred Qualifications

  • Scientific and technical acumen in Neurology, Hepatology, Gastrenterology, Lipidology and/or Bone Metabolism
  • Fluency in Spanish or Portuguese is a plus
  • Health Outcomes Research/Reimbursement Experience
  • Regulatory Affairs
  • Clinical Development Experience

Education

  • Must have a MD, PhD or PharmD level degree or equivalent
  • 3 years + experience in medical affairs/R&D organization ( Development, Phase IIIB/IV, med info, grant processing, ISR review, field Experience, Global KOL management, scientific communications & publications)
  • Experience leading cross-functional teams
  • Experience managing people
  • Experience in the Pharmaceutical or biotechnology industry

please email CV and cover letter to jobs@tseworldwide.com for consideration

Sr. Scientist-PK/PD

Boston, MA

Position Summary

We are seeking a highly motivated, collaborative, and innovative Senior Scientist, specializing in pharmacokinetics and pharmacology to join our protein therapeutics/biologics discovery efforts. The candidate will work with a world-class, multidisciplinary team of drug discovery scientists to lead the in vitro and in vivo ADME, PK, PD and toxicokinetic efforts to support biologics drug discovery and development. Specifically, the candidate will design, manage, and execute in vitro and in vivo programs both in-house and at contract research organizations. The candidate will also be responsible for analyzing, interpreting, and modeling DMPK and PK/PD data. The candidate will contribute to scientific publications and regulatory submissions as required.

Job Responsibilities

  • Design, conduct, and manage in vitro, and in vivo experiments to evaluate the ADME and PK profiles as well as toxicokinetics and immunogenicity of developmental biologics candidates both in-house and at contract research organizations
  • Develop and execute assays for measuring drug concentration, target engagement, and pharmacodynamic effects in vitro and in vivo
  • Champion innovation and new initiatives in discovery programs by proactively reviewing literature and other advancements in disease area biology
  • Interpret and present research data and findings in internal and external scientific meetings and conferences
  • Contribute effectively to patents, reports, and publications of scientific findingsE

Qualifications

  • Ph.D. in pharmaceutics, pharmacology, or a relevant scientific discipline and a minimum of 5-8 years’ experience in pharmacokinetics and pharmacology
  • Demonstrated knowledge of ADME, PK/PD, and bioanalytical development of protein therapeutics/biologics
  • Deep understanding of translational biology
  • Experience in bioanalytical techniques including assays for immunogenicity, in vitro and invivo toxicology, and histopathology preferred
  • Experience in assay development for target engagement and biomarker discovery preferred
  • Hands-on experience with LC-MS to analyze biological drug candidates preferred
  • Experience in contributing DMPK and pharmacology parts of regulatory submissionpreferred
  • Ability to collaborate with interdisciplinary team with excellent written and oralcommunication skills
  • Ability to multi-task to meet research and development goals
  • Drive to solve problems and ability to work independentlyCompensation is competitive and commensurate with experience. Competitive health, dental and vision coverage provided, as well as 401K and other benefits.To learn more or submit your resume, contact us at jobs@tseworldwide.com

COO-CBO-CFO

I am working with select VC backed, post Series A biotechs on opportunities in Boston/Cambridge and the Bay Area. Opportunities for CBO, COO and CFO (or hybrid) and Investor Relations. Ideal backgrounds include M&A, Investment Banking, Equity Research and Sr Strategy Consulting. Please let me know If you are considering an operating role in 2020 and send message to tsharon@tseworldwide.com to set up a conversation

Chief Business Officer – Boston Biotech

Boston, MA

The Chief Business Officer, will provide leadership in the evaluation, development, implementation, and management of partnerships, collaborations, and/or acquisitions.  This key strategic role will lead a team of functional experts in science, clinical, program management, global marketing, legal and finance to evaluate opportunities, develop relationships with external parties, and ensure the corporate business development strategy is successful.    

 The individual in this role will be part of  our  Strategy and Business Development Group encompasses corporate strategy, business / corporate development and new product planning.  A critical component of the group is the Business Development function as the Company evaluates, plans and executes strategic business development opportunities including acquisitions, licensing agreements and partnerships.

To be fully successful at developing and implementing corporate strategy, this position requires a creative and analytical thinker who has previous experience with traditional corporate strategy initiatives.  In regards to Business Development, this position requires disease strategy, diligence, transaction and post-integration / alliance management experience.  This position offers the opportunity to help drive key decision-making activities within the Company.

Strategy:

Research, evaluate and recommend potential growth strategies through expansion into new therapeutic categories, markets and related businesses

 Lead analyses of pre-commercial and commercial opportunities (including epidemiology modeling and detailed revenue projections) related to corporate/business development initiatives

 Lead external innovation opportunities to expand commercial opportunity of both marketed and clinical programs

 Collaborate with Executive team and lead the development of a global strategic plan and collaborate with Finance team on the corporate long-range plan

 Collaborate with business partners on issue specific long-range strategic implications (for example, manufacturing strategy, pre-clinical target assessments, portfolio planning, etc.)

 Collaborate with internal stakeholders on identifying and incorporating innovative technologies 

 Work on CEO and Board-related strategy projects as needed

 Business Development

 Support in all business development activities and due diligence which includes valuation modeling, partner outreach, and managing technical and business due diligence processes

 Provide effective support on due diligence, transaction and post deal integration initiatives under the umbrella of business development

 Participate in the development of strategic partnerships, joint ventures and alliances, as well as platform technology and intellectual licensing opportunities

 QUALIFICATIONS AND BACKGROUND REQUIREMENTS

 Educational Requirements

 BS/BA required (MBA preferred)

 Professional Work Experience

 Minimum of 7 years of related experience in the biotech/pharmaceutical industry 

 Healthcare corporate strategy and transactional business development experience required

 Three plus years investment banking, strategic consulting, or related experience strongly preferred

 Deal / track record of successful identification, diligence and closing of opportunities 

 Rare disease experience strongly preferred

 Exceptional project management skills with ability to manage multiple projects in a cross-functional environment with good understanding of project management process

 Demonstrated competency in strategic thinking and leadership, with strong abilities in relationship management

 Demonstrated competency in conflict management, influence and negotiation skills

 Self-motivated, energetic individual who is dedicated to serving the needs of the rare and orphan disease community

 Strong customer focus with the ability to adapt to internal client needs and expectations

 Strong ability to influence outcomes without direct authority and ability to hold oneself and others accountable for commitments

 Highly organized and detail oriented with excellent follow-up abilities

 Strong familiarity with preclinical science, drug development and lifecyclmanagement of pharmaceuticals

 Ability to create and deliver effective presentations to working teams and senior management 

 Ability to create complex excel-based forecasts, NPV models and returns analyses

 Strong communicator and presenter, with the ability to persuade others and foster open communication across internal and external groups

***Interested candidates should email resume to jobs@tseworldwide.com for consideration

Director, Global Marketing, -Neuromuscular

Director, Global Marketing, -Neuromuscular (Location Open)

We are recruiting for the position of Director, Global Marketing, Neuromuscular who will be responsible for the development and execution of Global marketing strategies and tactics for our portfolio.

Reporting to the Therapeutic Area Lead, the Director will be in a critical position working cross functional teams, regional, country and corporate leadership and to advance care in the rare disease community and drive commercial success.

The Director, Global Marketing ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONSPrimary duties/responsibilities:

  • Assists in the development and execution of the Global strategic and tactical plan
  • Ensures strategic alignment between the Global strategic and tactical plan with the regions and countries
  • Develops the Global communication platform including key elements of positioning, messaging, value proposition, creative campaign, and promotional pieces
  • Creates and implements global educational initiatives (e.g. symposia, speaker’s bureau, stand-alone events) to raise disease awareness, increase patient identification, and drive belief in Translarna and Emflaza
  • Plans and executes HCP and patient market research and advisory board meetings to gain actionable market and customer insights
  • Works cross functionally to identify and partner with global KOLs
  • Understands the challenges and growth opportunities in the rare disease community and translating these into marketing initiatives
  • Plans and executes global congress activities
  • Manages external agencies to ensure execution of marketing programs aligned with brand strategy objectives
  • Ensures timely and efficient review of promotional materials and complying fully with all legal, regulatory, ethical, and company guidelines
  • Works with stakeholder partners in Medical Affairs, Marketing, Market Access, regional and country leadership, Distribution and Finance to optimize commercial success for the near term and future product launches
  • Leads a culture of compliance, integrity and transparency
  • Manages the operating budget(s) and initiating corrective measures as appropriate
  • Performs other tasks and assignments as needed and specified by management

KNOWLEDGE/SKILLS/ABILITIES REQUIREDMinimum level of education and years of relevant work experience.

  • 7 + years of experience in Global Marketing or other relevant functions
  • Launching and managing products globally in complex rare disease markets
  • Minimum of Bachelor’s Degree; Master in Science or MBA preferred

Special knowledge or skills needed and/or licenses or certificates required.

  • Demonstrated track record of success supporting the marketing and commercialization of an orphan, rare disease and/or specialized drug(s) that requires the development and execution of unique sales and marketing strategies.
  • Demonstrated success in developing and executing long term and annual marketing plans.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Analytical thinker with strong problem-solving skills and the ability to adapt to changing priorities and deadlines. 
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 
  • Ability to anticipate issues and respond quickly, flexibly and creatively to solve problems and address commercial market challenges
  • Hands-on experience in collaborating and working with patient organizations.
  • Ability to influence without direct authority.
  • Proficiency with Microsoft Office
  • Excellent verbal and written communication and skills.
  • Fluent in English (verbal and written).

to apply please send resume and cover letter to jobs@tseworldwide.com

Head of Developmental Sciences – San Diego

The Developmental Sciences Department is dedicated to strategies that bridge preclinical research and clinical development. Reporting to the CMO, this position will lead a team of scientists and/or physicians in defining and implementing translational initiatives. The incumbent will work cross-functionally to establish and implement research collaborations with other functional areas within the Company including clinical pharmacology, predictive biomarkers, pharmacodynamic biomarkers, and pharmacovigilance. This work will impact project level decision making and will require effective communications across a broad range of constituencies.

Key Responsibilities

  • Work with Team members and key partner functions (including Regulatory, Commercial, Nonclinical Development, etc.) to define biomarker strategies
  • Oversee the discovery and development of development and provide guidance to potential partners for co-development of companion diagnostics 
  • Collaborate with colleagues in research and other departments to advance internal research and early development projects 
  • Manage, mentor, advise and foster the career development of a diverse group of development sciences team professionals
  • Contribute to the Translational Medicine Team’s mission to understand the mechanism(s) of action 
  • Provide Translational Medicine support to partner functions; this may include providing input into clinical protocols, informed consents, sample collection manuals, investigator brochures and regulatory documents; helping to resolve biomarker-related questions from regulatory agencies; reviewing and interpreting clinical study outcomes, and overseeing the presentation of relevant results in clinical study reports and other study documents 
  • Maintain a strong understanding and awareness of emerging medical and diagnostic developments 
  • Develop models, both preclinical and clinical, to ensure robust decision making on developability of drug molecules in various therapeutic areas of interest
  • Design proof of concept studies and full development for various therapeutic area programs
  • Contribute to and review the clinical section of documents including, but not limited to, Protocols, the Investigator Brochure (IB), Case Report Forms (CRFs), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, patient narratives, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview

Education & Experience

  • A minimum of an M.D. or Ph.D. with at least 10 years drug development experience in a biopharmaceutical environment 
  • Demonstrated experience in development, implementation and execution of clinical development strategies for novel drug candidates, from preclinical development through clinical proof-of-concept 
  • Successful track record with biomarkers in the clinical space including development and implementation of biomarker strategies required 
  • Hands-on experience establishing clinical, molecular and cellular diagnostics 
  • Working knowledge of GCP and FDA regulations 
  • Advanced knowledge of immune-oncology and emerging therapies in oncology. 
  • Detail-oriented with the drive and ability to prioritize workload with limited supervision 
  • Strong interpersonal skills and the ability to function in a team environment 
  • Excellent written communication and oral presentation skills 
  • Phase 3 clinical development experience desired

to apply please send resume and cover letter to jobs@tseworldwide.com

Head of Regulatory – Gene Therapy -NJ/Boston/San Francisco

RESPONSIBILITIES:

Reporting to the Chief Development Officer the successful candidate will:

  • Act as the regulatory lead on specific program(s) and represent the regulatory function on related cross-functional program teams
  • Participate in definition and implement regulatory strategy for path to approval
  • Plan, prepare, and review submissions to regulatory authorities (including FDA, EMA and other national authorities) to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
  • Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Be the primary liaison with regulatory authorities for the specific programs he/she is leading
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Train and mentor other regulatory affairs personnel
  • Other activities as may be assigned

To apply please email resume and cover letter jobs@tseworldwide.com

Chief Medical Officer – Oncology; CT

Chief Medical Officer will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

The Chief Medical Officer will report to the Chief Executive Officer and will be part of the Executive Leadership team.

Additional responsibilities required include:

  • Drive strategy and execution of clinical and regulatory development activities from pre-IND through clinical development
  • Directly supervise clinical operations, clinical research, data management and analysis, regulatory and medical affairs, and support related hiring strategy and decisions
  • Supervise development of patient registry and / or natural history studies 
  • Manage the analysis, interpretation and reporting of clinical trial data and results 
  • Work with internal and external parties to develop target product profiles and translate these product profiles into clinical development
  • Provide strategic input supporting prioritization of preclinical programs, in collaboration with Chief Science Officer
  • Collaborate with Chief Science Officer to move discovery / preclinical product candidates into clinical investigations / development
  • Help establish Company culture in a manner consistent with the company’s values
  • Communicate on behalf of the Company with key opinion leaders and patient communities at conferences and other external events, and also with investors, in a manner supportive of the Company’s objectives
  • Represent the Company with regulatory and legislative agencies 
  • Develop and manage clinical and regulatory budget

Qualifications

Education and Experience: 

  • MD / PhD 
  • Minimum of 10 years relevant experience in all aspects of designing and executing clinical trials, including early clinical / translational development and mid to late stage clinical development and execution 
  • Experience in managing clinical operations, regulatory affairs and medical affairs groups

Knowledge and abilities:

  • Expert knowledge of rare disease clinical trial design and analysis
  • Deep scientific, technical, and regulatory understanding of drug development
  • Budget management and project management experience
  • Team player with executive demeanor, strong judgement, and decision-making capabilities
  • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
  • Highly motivated individual who can accommodate the demands of a rapidly growing biotechnology company

Additional information

  • Position is located in Boston, Massachusetts and will require up to 25% travel 

Applicants should send CV and cover letter to jobs@tseworldwide.com

Gene Therapy – Leadership Opportunities

TSE is pleased to announce a partnership with several early stage (pre-IPO) but well funded companies in the AAV Gene Therapy space in Boston and Cambridge, MA, NYC, Philadelphia and San Francisco

Open positions will be created and posted soon but will include:

  • CSO
  • S/VP Head of Translational Biology
  • CMO
  • Head of Clinical Development
  • Director, Clinical Operations and Program Management

We’re very excited to be able to collaborate with these companies working to advance potential life saving treatments across many Rare Diseases

Please stay tuned for updates here and on LinkedIn

Feel free to email me as well Email

 

 

Recruiters -any location

We are looking for recruiters of any level to come work with us.

Please visit our careers page https://wp-k1hwq7y3c2.pairsite.com/category/careers/ to see the positions we typically support for our clients.

Send resume and cover letter to jobs@tseworldwide.com

CNS Research Scientist I / II

This position is part of our CNS gene therapy team and involves contributing experience and knowledge to the design and analysis of animal studies using AAV vectors. This includes the development of strategies to test these reagents both in vitro (e.g. primary human cells and iPSCs) and in vivo (mammalian model systems). The position further requires remote management of CROs, site visits, and hands-on analysis of study samples. The position also supports the development of techniques and processes for the successful translation of this technology into the clinic.

The position requires a capacity for constant innovation in pursuit of company goals, creativity, and adaptability. The environment is exciting, fast-paced, and offers the opportunity to work at the cutting edge of gene therapy for rare CNS diseases and small molecule development for cancer.

Responsibilities:

  • –  Management of CROs for CNS centric in vitro and in vivo studies
  • –  Protocol development for in vivo studies in disease models
  • –  In vitro testing of patient-derived iPSC and differentiated cells
  • –  In vitro testing of AAV lead designs
  • –  Oversight of small molecule lead compound validation in vitro and in vivo
  • –  Understanding and interpretation of patient-related data and its integration with experimental and therapeuticdesignRequirements:
  • –  Ph.D. in CNS biology or related field
  • –  Experience with CNS-targeted AAV gene therapy and the generation/use of AAV gene delivery vectors
  • –  Proficiency in brain physiology / pathology
  • –  Extensive experience with mammalian cell culture
  • –  Mastery of basic molecular biology and biochemistry
  • –  Strong communication and data presentation skills
  • –  Ability to work in a team-oriented, multidisciplinary environment

Chief Financial Officer -Boston/NY/San Francisco

Several of our Biotech client have reached out to discuss 2019 CFO hires.

For consideration or to set up time to discuss, please contact

tsharon@tseworldwide.com

Gene Therapy News

After a recruiting journey with candidates from Europe, Asia and all over the US, I am happy to announce that our client Grace Science, LLC has selected a Bay Area local to lead their ambitious R&D effort in Gene Editing/Gene Therapy, Rare Diseases, Neuromuscular and Oncology. It has been a privilege to work with the team and I am certain great things are to come.

For more information about Grace Science and their technology please visit

S/VP – Clinical Development

VP/SVP -Clinical Development (Rare Genetic Diseases)

Boston or Cambridge, MA

The VP/SVP Clinical Development (Rare Genetic Diseases) will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

Additional responsibilities required include:

  • Drive strategy and execution of clinical and regulatory development activities from pre-IND through clinical development
  • Directly supervise clinical operations, clinical research, data management and analysis, regulatory and medical affairs, and support related hiring strategy and decisions
  • Supervise development of patient registry and / or natural history studies
  • Manage the analysis, interpretation and reporting of clinical trial data and results
  • Work with internal and external parties to develop target product profiles and translate these product profiles into clinical development
  • Provide strategic input supporting prioritization of preclinical programs, in collaboration with Chief Science Officer
  • Collaborate with Chief Science Officer to move discovery / preclinical product candidates into clinical investigations / development
  • Help establish Company culture in a manner consistent with the company’s values
  • Communicate on behalf of the Company with key opinion leaders and patient communities at conferences and other external events, and also with investors, in a manner supportive of the Company’s objectives
  • Represent the Company with regulatory and legislative agencies
  • Develop and manage clinical and regulatory budget

Qualifications

Education and Experience: 

  • MD / PhD
  • Minimum of 10 years relevant experience in all aspects of designing and executing clinical trials, including early clinical / translational development and mid to late stage clinical development and execution
  • Experience in managing clinical operations, regulatory affairs and medical affairs groups

Knowledge and abilities:

  • Expert knowledge of rare disease clinical trial design and analysis
  • Deep scientific, technical, and regulatory understanding of drug development
  • Budget management and project management experience
  • Team player with executive demeanor, strong judgement, and decision-making capabilities
  • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
  • Highly motivated individual who can accommodate the demands of a rapidly growing biotechnology company

Additional information

  • Position is located in Boston, Massachusetts and will require up to 25% travel

Interested candidates should email CV to tsharon@tseworldwide.com

Chief Medical Officer – Boston

Chief Medical Officer will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

The Chief Medical Officer will report to the Chief Executive Officer and will be part of the Executive Leadership team.

Additional responsibilities required include:

  • Drive strategy and execution of clinical and regulatory development activities from pre-IND through clinical development
  • Directly supervise clinical operations, clinical research, data management and analysis, regulatory and medical affairs, and support related hiring strategy and decisions
  • Supervise development of patient registry and / or natural history studies 
  • Manage the analysis, interpretation and reporting of clinical trial data and results 
  • Work with internal and external parties to develop target product profiles and translate these product profiles into clinical development
  • Provide strategic input supporting prioritization of preclinical programs, in collaboration with Chief Science Officer
  • Collaborate with Chief Science Officer to move discovery / preclinical product candidates into clinical investigations / development
  • Help establish Company culture in a manner consistent with the company’s values
  • Communicate on behalf of the Company with key opinion leaders and patient communities at conferences and other external events, and also with investors, in a manner supportive of the Company’s objectives
  • Represent the Company with regulatory and legislative agencies 
  • Develop and manage clinical and regulatory budget

Qualifications

Education and Experience: 

  • MD / PhD 
  • Minimum of 10 years relevant experience in all aspects of designing and executing clinical trials, including early clinical / translational development and mid to late stage clinical development and execution 
  • Experience in managing clinical operations, regulatory affairs and medical affairs groups

Knowledge and abilities:

  • Expert knowledge of rare disease clinical trial design and analysis
  • Deep scientific, technical, and regulatory understanding of drug development
  • Budget management and project management experience
  • Team player with executive demeanor, strong judgement, and decision-making capabilities
  • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
  • Highly motivated individual who can accommodate the demands of a rapidly growing biotechnology company

Additional information

  • Position is located in Boston, Massachusetts and will require up to 25% travel 

Applicants should send CV and cover letter to jobs@tseworldwide.com

 

Executive Medical Director- NY Biotech

Executive Medical Director- NY (Immunotherapy)

Job Description

Works with the CMO, CSO and the CRO team members to develop and translate clinical strategy into trial options and protocols.

Performs clinical monitoring of one or more studies.

Conducts Medical Data Reviews (and data cleaning support as appropriate) of ongoing studies working with clinical operations and data management groups.

Addresses relevant clinical queries from study sites with documentation.

Identifies and builds relationships with investigators.

Contributes to Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).

Supports generation and coordination of clinical documents and deliverables in support of regulatory filings.

Responsible for the study timelines in a cross-functional matrix protocol team.

Responsible for the clinical development activities from site(s) initiation to study discontinuation.

Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements.

In collaboration with the CMO and CRO, designs and implements safety monitoring plans.

Interprets clinical data and makes appropriate decisions and recommendations.

Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions.

Work with the Program Lead, team members and governance bodies to translate the strategy into trial options, protocols and action plans.

Work with the investigators to author clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview.

Works consistently in a matrix environment.

 Qualifications and Requirements

MD, PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology and cell therapy, or equivalent therapy area knowledge

Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry – e.g. monitoring)

Management of one or more uncomplicated studies and preparation of regulatory documents

Relevant clinical research experience (relevant academic research experience could potentially substitute)

Possesses a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock

Possesses a history of handling multiple, complex, studies in parallel

Possesses a history of prior meaningful participation in regulatory submissions

Possesses a history of strong interaction with thought leaders

Proven team leadership capability

Performs as an individual contributor

Identifies when an issue is present and begins to address

 Essential Leadership Behaviors

Identify and builds relationships with study investigators

Is seen and acts as the study expert by the site personnel

Ability to work and communicate efficiently with internal partners in the US for positions located outside the US

Identify and builds relationships with principal investigators

Identify Thought Leaders and use them for inputs in clinical strategy and protocol design

Maintain a strong medical/scientific reputation within the disease area

Contribute to interactions as a medical monitor on assigned clinical studies

Share specific clinical strategies with CMO and CSO

Study-specific clinical design and execution

Manage communication with key stakeholders (senior)

Candidates should email CV and cover letter to jobs@tseworldwide.com

 

VP/SVP -Clinical Development (Rare Genetic Diseases)

Boston or Cambridge, MA

The VP/SVP Clinical Development (Rare Genetic Diseases) will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

Additional responsibilities required include:

  • Drive strategy and execution of clinical and regulatory development activities from pre-IND through clinical development
  • Directly supervise clinical operations, clinical research, data management and analysis, regulatory and medical affairs, and support related hiring strategy and decisions
  • Supervise development of patient registry and / or natural history studies
  • Manage the analysis, interpretation and reporting of clinical trial data and results
  • Work with internal and external parties to develop target product profiles and translate these product profiles into clinical development
  • Provide strategic input supporting prioritization of preclinical programs, in collaboration with Chief Science Officer
  • Collaborate with Chief Science Officer to move discovery / preclinical product candidates into clinical investigations / development
  • Help establish Company culture in a manner consistent with the company’s values
  • Communicate on behalf of the Company with key opinion leaders and patient communities at conferences and other external events, and also with investors, in a manner supportive of the Company’s objectives
  • Represent the Company with regulatory and legislative agencies
  • Develop and manage clinical and regulatory budget

Qualifications

Education and Experience:

  • MD / PhD
  • Minimum of 10 years relevant experience in all aspects of designing and executing clinical trials, including early clinical / translational development and mid to late stage clinical development and execution
  • Experience in managing clinical operations, regulatory affairs and medical affairs groups

Knowledge and abilities:

  • Expert knowledge of rare disease clinical trial design and analysis
  • Deep scientific, technical, and regulatory understanding of drug development
  • Budget management and project management experience
  • Team player with executive demeanor, strong judgement, and decision-making capabilities
  • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
  • Highly motivated individual who can accommodate the demands of a rapidly growing biotechnology company

Additional information

  • Position is located in Boston, Massachusetts and will require up to 25% travel

Interested candidates should email CV to tsharon@tseworldwide.com

Bay Area VP Positions Filled- Rare Diseases

I am thrilled to announce that after fewer than 5 weeks, we have had two VP roles have offers accepted for a rare disease client in the San Francisco Bay Area.

This was a national search bringing VP level talent from powerhouse commercial pharmaceutical companies to a company preparing to launch multiple assets.

To view the full positions:

VP, Market Access

VP, Commercial Analytics

To find out more about helping your company with open positions, contact me at jobs@tseworldwide.com

To see if an open opportunity is right for you, please visit out Careers page

 

Executive Director; Medical Strategy

Executive Director; Medical Strategy- Boston

Duties and Responsibilities: 

  • Serve as U.S. Medical Director for multiple global clinical development trials and/or U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use).  Interface with Global and U.S. Clinical Team Members, Clinical Operations, Scientific Operations, Regulatory Affairs, Drug Supply, Data Management, Finance, Quality, Compliance, and other relevant functional areas as well as Partners.
  • Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards including:
    • Write and review protocols that are in-line with the overall indication strategy.
    • Conduct medical review and interpretation of efficacy and safety data from clinical trials.
  • Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, clinical expert reports, and label reviews.
  • Review and provide US feedback to Global Protocols and Global Development Plans.
  • Develop strategy for US Medical Affairs including exploratory indications and integrate US plan with overall Global Medical Affairs strategy.  Oversee the review and approval of IIT concepts. Oversight during the conduct of trials including safety monitoring.  Review of interim and final publication, manuscripts, or abstracts.
  • Provide strategic input to individual clinical trial strategy and participate in strategy setting for clinical trial program.
  • Supervise and manage individuals on the US CDMA team as appropriate. Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
  • Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (i.e. IB, IND sections), for Company Sponsored project.
  • Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review.
  • Present and discuss data and findings at relevant internal and external meetings.
  • Lead US cross functional Medical Product Teams and activities; Medical representative to the Brand team.
  • Support and participate in FDA meetings including presentations, briefing books, and responding to FDA inquiries as needed.
  • Extensive interactions with academic thought leaders to optimize clinical trial strategies.
  • Extensive interactions with other functional teams including HEOR, Medical Information, Scientific Communication, Commercial, Regulatory and others, to define compound strategy and projects.
  • Coach and train internal colleagues as requested.
  • Assist in the development and appropriate spending of clinical budget.
  • Ensure adherence to GCP/ICH and company Standard Operating Procedures (SOPs).

Experience and Qualifications: 

  • MD, board certified or board eligible in either internal Medicine, Endocrinology, Cardiology or relevant Medical Specialty preferred.
  • At least 5 years of experience in Diabetes clinical research in the pharmaceutical industry OR experience in clinical research or medical affairs is preferable or a combination of experience in academic medicine with clinical research and or clinical development experience in collaboration with the pharmaceutical industry. 
  • Scientific medical research experience in Cardiology, Diabetes or Metabolism with demonstrated record of scientific medical publications. Experience within diabetes therapeutic area highly preferred. 
  • Experience leading the design, conduct, analysis and reporting of clinical studies is strongly preferred.
  • Superior leadership, networking, collaboration and communication skills.  
  • Successful interactions with Medical Experts and investigators.
  • Demonstrated the capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.
  • Ability to work across multiple functions is essential.  
  • Effective oral and written communications skills and strong leadership are essential for success in the role.

Please email CV to jobs@tseworldwide.com

 

Investment Banking Associate -Healthcare

Investment Banking Associate -Healthcare, NYC, SFO and Boston
The Healthcare Investment Banking Group is seeking candidates for an Investment Banking Associate on the Healthcare team.  The investment banking Associate executes M&A and capital raising transactions for both private and public companies as well as develops pitch materials to secure new business. Associates are immediately assigned to live deal teams and given as much responsibility as their experience and capabilities permit. With supervision from senior bankers, an Associate will prepare offering memorandums, management presentations, complex company models and various valuation analysis, including fairness opinions for public company sales. As an Associate’s skills develop, additional responsibilities will include taking primary responsibility for deal execution of all types of transactions, maintaining client relations during the deal execution period, building industry-specific or product-specific expertise, initiating new client relationships and expanding a business franchise within a designated industry/product sector. Associate are actively involved in day-to-day transaction execution, gaining significantly more client interaction and live deal experience than their peers at Wall Street firms.

Candidates for this position must have:

• At least one year of experience as an Investment Banking Associate or three years at the Investment Banking analyst level
• Strong preference an Associate with M&A transaction experience
• an MBA from a top tier business school preferred with approximately 3 to 4 years of post-undergraduate work experience
• excellent writing skills to convey complex business strategies thoughtfully and concisely
• excellent analytical and modeling skills
• strong client management skills

Job requirements will include, among others:

•  writing thoughtful, concise and persuasive offering memorandums
•  financial statement modeling and analysis
•  preparing and delivering presentations
•  performing extensive valuation and pricing analyses
•  supervising and developing analyst level bankers
•  playing key leadership roles in the transaction execution process

Qualified candidates should send resume and deal sheet to jobs@tseworldwide.com

Senior Medical Director, Life Cycle Management The Head of Life Cycle Management

Senior Medical Director, Life Cycle Management The Head of Life Cycle Management (LCM), Global Medical Affairs _Cambridge, MA

is a high visibility, strategic and operational leadership position reporting to Head MS Global Medical Affairs. This is an exciting opportunity to work in a patient-centric, high performance culture. The Head of Life Cycle Management, Global Medical Affairs will be a member of the MS Global Medical Affairs team, providing input into novel life cycle management opportunities for products in Phase IV and the commercialized portfolio to ultimately improve therapeutic and compliance benefits to MS patients while expanding the development pipeline. The Head of LCM has a crucial role in the development of the yearly Global Medical Affairs Plan, making sure the LCM strategy is aligned with the identified critical success factors. He/she will work in a matrix participating as a member of various Medical Affairs, Clinical Sciences & Operations (CSO), and cross-functional teams and committees to further strengthen the Ph. III b and IV study development of the MS Franchise. Partnering with and providing input to Product Lead(s) and Launch/Commercial Team(s) to define global product launch and life cycle management strategy to impact the achievement of objectives and maximize the value of each product in the franchise is a critical component of this role. The Head of LCM will partner with Clinical Sciences & Operations (CSO) teams while being responsible for coordinating, overseeing, and providing guidance to the MA teams throughout the organization to guarantee seamless and timely execution of the Ph. III b/ Ph. IV program of Genzyme sponsored studies (GSS). This will include managing a team of professionals (MDs, PhDs, project managers) driving the LCM working group across the organization for our current franchise and becoming involved in new programs as they reach Ph. III to strengthen the pre-launch efforts. Support the successful launch and life-cycle management of Genzyme’s marketed product portfolio through innovative thinking and approaches in all areas including Genzyme sponsored studies (GSS) as well as independent research projects to generate data on drug MoA, long term benefit, long term safety, and patient reported outcomes, in close alignment with the Global Medical Affairs Plan. The Head of Life Cycle Management co-chairs the Scientific Review Committee for both Genzyme and Investigator’s initiative studies, coordinates synopsis development for the GSS, provides input into the yearly defined ISS strategies for each of the MS drugs, and coordinates the ISS monthly updates. The exceptional leader that we seek will be responsible to: •Provide leadership to Ph. IV programs to define life-cycle management strategy identify needs for high value post-marketing clinical trials and registries and oversee their management and execution.

•Develop medical strategies to obtain relevant data evidence from company and Investigator Sponsored Studies (ISS), including Real World Evidence, consistent with strategic objectives for each product. Ensure that appropriate processes are in place for review, approval, management and support of studies while maintaining investigator independence.

•Communicate product life-cycle management strategy to regional/local Medical Affairs experts and product managers. Ensure that studies planned by regional and local affiliates fit into the global product strategy.

•Ensure and oversee the planning, execution and reporting of clinical studies as defined in the Global Medical Affairs plan and in accordance with established budgets and timelines. Monitor performance of phase IV activities (e.g. value creation) from conception through publication of clinical study results and take corrective actions or escalate issues as appropriate. Contribute to continuous improvement of phase IV study related processes and best practices.

•Lead/co-chair team(s) responsible for peri-/post-approval data analyses and evaluations to ensure appropriate prioritization of resources and effort towards generation of medical-scientific results in support of key publications, health authority and market access requests, as needed.

•Establish a strong network within the MA organization (Global, Regional and local) and also with other stakeholders namely the R&D, the Clinical Sciences & Operations (CSO), and Pharmacovigilance teams. •The financial management and reporting requirements of LCM studies and ISSs with accurate and timely data and assumptions to support budgeting, forecasting and long range planning for the business unit. •Represent the Global MS Medical Affairs team at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KOLs. Basic Qualifications

•Either advanced degree (e.g. MPH, PhD or M.D.) combined with industry experience working in related areas (e.g. LCM, Clinical Development, Project Management, etc.), preferably related to MS. Well established leadership and management skills in attracting, mentoring and retaining high performing medical affairs professionals.

•Experience in managing clinical trials in a pharmaceutical or equivalent environment is strongly desired. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management, regulatory requirements and compliance for conduct of clinical research essential.

Preferred Qualifications

•Demonstrated ability to work effectively in a matrix environment.

•Excellent skills working cross functionally, specifically partnering with all the internal and external stakeholders.

•High energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives.

•Comfort operating in a consensus building role but also able to make critical decisions and drive these decisions through the organization. 

Principal or Senior Scientist, Vector Design AAV

Principal or Senior Scientist, Vector Design AAV – Bay Area


RESPONSIBILITIES: 

This is a position for a highly innovative, passionate, and energetic Scientist to develop adeno-associated viral vector technologies in an industry setting. The candidate should be extremely motivated to drive drug development. The Principal or Senior Scientist is part of a multidisciplinary research team responsible for using BioMarin’s Proprietary technology platform to develop gene therapy applications. 

Responsibilities include: 

  • Identification and development of new AAV Applications
  • AAV Capsids development
  • Vector design
  • Optimize Vector Cassette
  • Assist in management of projects with partners and/or contract laboratories


EXPERIENCE: 

  • Preferably 7+ years of experience working as a scientist in an academic, research, laboratory setting or biotech/pharma company
  • This person must have extensive experience engineering AAV vectors
  • Exceptional publication record in leading peer reviewed journals
  • Experience interpreting and presenting data to internal and external stakeholders, and at national and international meetings
  • Strong critical, scientific, and strategic thinking skills; Strong problem solving and decision making abilities
  • Strong communication (verbal and written) skills
  • Experience and ability to work collaboratively in cross-functional teams
  • Drug development and/or extensive research training


EDUCATION: 

  • A Ph.D. in the Biomedical Sciences.
  • Strong consideration given to Molecular Biologists

Email resume or CV to jobs@tseworldwide.com

 

Sr Medical Director – Oncology Colorectal Cancers – Immunotherapy

Director/Sr. Director, Global Product Medical Leader to support colorectal cancer products, and  plus selected products in the Oncology pipeline. Assignment of pipeline products may be influenced by the successful candidate’s past experiences and areas of expertise.  The new Director/Sr. Director will report directly into the Vice President, Global Medical Affairs Oncology.

The ideal candidate will have the following mix of professional and personable characteristics:

  • Multiple myeloma expertise
  • MD, Board Certification in Oncology/Hematology or Pediatric Oncology/Hematology.
  • Industry experience in Medical Affairs is preferred.
  • Sound scientific and clinical judgment, including in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
  • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials.
  • Broad and formal leadership experience, including excellent “leadership presence” to represent Medical Affairs within the company, to other functions, and to leaders at every level.
  • Excellent skills working with experts from other functions and countries and influencing decision making without authority in a complex and matrix environment.
  • High energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives.
  • Demonstrated ability to inspire confidence while working effectively in a matrix environment.
  • Comfort operating in a consensus building role but also able to make specific recommendations and decisions and drive for implementation.
  • Ability to inspire confidence, both internally and externally – leading by example and demonstrating collaborative behavior.
  • Demonstrated ability to organize and lead expert Clinical Research Advisory Panels.
  • Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders.
  • Excellent communication skills with the ability to build solid working relationships with the commercial organization, as well as negotiate and influence across cultures.

Apply by emailing resume to jobs@tseworldwide.com

Director, Medical Affairs – Immuno-Oncology

  • MD, Board Certification in Oncology/Hematology or Pediatric Oncology/Hematology.
  • Immuno-oncology treatment expertise
  • Industry experience in Medical Affairs or Clinical Development.
  • Opportunities with clients in NJ, PA, MA, CA and WA

Please send message to jobs@tseworldwide.com for client disclosures

Chief Medical Officer – Hematology / Oncology

Seeking a creative translational medicine expert to develop and execute the clinical research and development plan for the company. This key position with be responsible for evaluating the current Hematopoietic Stem Cell Transplantation landscape and building the translational science strategy for novel drug development programs. The successful candidate will identify and develop relationships with key opinion leaders, patient advocacy groups, academic institutes and hospitals to integrate novel advances in transplantation research into the drug development process and clinic.

Responsibilities/Requirements

  • Lead the clinical development strategy and be accountable for the execution of the translational medicine effort within the company
  • Collaborate closely with internal research team to integrate translational research into research, development and clinical strategies
  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators
  • Lead internal and external team members, vendors and consultants to develop an IND package, as well as review and evaluate pre-clinical safety data for submission
  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports
  • Organize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings
  • Support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities
  • Travel, as needed, nationally and internationally

Qualifications

  • Candidate must possess an MD with research experience or an MD / PhD, as well as a fellowship in Hematology/ Oncology or related areas
  • The ideal candidate will have several years of clinical experience in stem cell transplantation within academic medical, pharmaceutical and/or biotechnology sectors
  • Extensive experience in translational or clinical research related to drug development is required: biotech/ pharma experience favorably considered
  • Experience with developing regulatory strategy, including experience with IND-enabling, Phase I and Phase II studies preferred
  • Broad therapeutic area and target class expertise and experience in one of the following; Hematology/ Oncology, Auto-immunity and/ or Hematological Rare Genetic Diseases
  • Ability to identify and build relationships with thought leaders and leading clinical centers
  • Strong academic record with high quality peer-reviewed publications that demonstrate research productivity and the ability to perform cutting edge research in stem cell biology/transplantation and/or gene therapy
  • Effective communications (verbal & written) and presentation skills are essential

 

To apply, please submit your resume to jobs@tseworldwide.com

 

Head of US Market Access, Value and Pricing Practice Lead

We have a tremendous opportunity (or opportunities) to join the premier “top tier” Management Consultancy as they continue to build a US Market Access, Value and Pricing division.  There is an existing group in place that has been extraordinarily successful with big pharma and now they are working to build off of this success. Please contact me for more details!

jobs@tseworldwide.com