Category: Genomics

Immuno-Oncology Biotech in NJ

  • Our primary focus is targeted virotherapy, based on a fundamental mediator of cell immortalization in cancer 
  • Our goal: unlock the full potential of our virotherapy platform to treat a wide range of solid tumors, even immunologically cold tumor types

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

Director, Clinical Development and Medical Affairs Strategy; NJ

Summary:

This position is responsible for the strategic clinical leadership for clinical development and medical affairs activities in support of the early and late-stage development portfolio in immuno-oncology. This role requires an individual with strong communication and leadership skills, as well as the ability to build strong relationships with key stakeholders (including overseas HQ) in R&D, Medical Affairs, Business Development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific partner who can readily bridge between a cutting-edge research environment and a fast-paced clinical and product development organization. The successful candidate is expected to help drive effective pre-launch clinical development and medical affairs activities and to represent the department and programs at internal and external meetings. The individual should also have experience in regulatory affairs with CBER on immunotherapy.

Essential Functions

  • Provide exceptional scientific and regulatory expertise and collaboration within medical team, to your peers within the group, and to the organization in general.
  • Contribute to the formation, refinement and execution of medical strategies and tactics including early phase 1b/2 and late-stage 2/3 including Investigator-Initiated Study and/or company sponsored studies and ensure medical plans optimally are integrated into Lifecycle Management (LCM) through appropriate collaborations.
  • Establish and maintain relationships with KOLs, investigator sites, cooperative groups, professional societies in oncology, patient groups, and external consultants.
  • Ensure medical and product information is provided in compliance with relevant SOPs and that all data used in the provision of medical information are accurate and meet the needs of internal and external customers.
  • Contribute to the development of a strategic and robust Medical Advisory Board plan that aims to enhance product knowledge and to inform on clinical practice patterns and gaps.
  • Assist in the preparation publications of clinical study data and maintain a publication plan for our oncology portfolio.

Competencies:

  • Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
  • Excellent oral and written communications with ability to present data to all levels of audiences.
  • Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
  • Strong capability of strategic thinking and proposing innovative solutions to issues.
  • Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.

Required Education and Experience:

  • Minimum of 8 years of experience in clinical research working in a pharmaceutical, biotechnology or related environment.
  • Working knowledge of Clinical Drug Development.
  • Working knowledge of Regulatory requirements as pertained to biologics.
  • Working knowledge of Good Clinical Practice (GCP)
  • PhD degree preferred (Immunology or Oncology)

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

Sr. Vice President, Commercial


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

Global Sales and Marketing – Healthcare

Coming Soon…

Executive Level Sales and Marketing – Commercial Launch

For a preview discussion, please contact me tsharon@tseworldwide.com

Bay Area Biotech – COO or CBO

Bay Area Biotech seeded through 2021 with full Gene Therapy development team is seeking a COO or CBO

Ideal candidate has deep scientific background, preferably a PhD and has helped scale biotech business through early iterations. Alternative is successful strategy/management consultant with operating experience ready to take on this amazing leadership role.

For a full discussion, please email tsharon@tseworldwide.com

CSO/Head of Discovery AutoImmune Rare Disease

Head of R&D – Rare Disease,  San Francisco or Redwood Shores, CA

Job Description

The Chief Scientific Officer (CSO) will lead our research programs from hypotheses to clinical trials. The CSO will lead all preclinical activities (discovery, development, etc.)

Responsibilities

Preclinical

  • Evaluate current therapeutic avenues under investigation  and conceive of additional options to pursue, then contribute to program selection
  • Establish clear expectations and priorities and drive key initiatives to completion
  • Guide preclinical R&D for multiple programs
    • Plan research activities so they enable Investigational New Drug (IND) submission
    • Work with internal members and outside contractors to prepare research protocols
    • Analyze and interpret data, then advise on follow-up studies
  • Oversee preparation and submission of patent applications

Clinical

  • Lead IND through NDA (New Drug Application) submission processes
  • Interact with regulatory authorities and advisors to facilitate safe and rapid translation of preclinical research to clinical trials
  • Design clinical research study protocols, including objectives, patient inclusion/exclusion criteria, dose selection, endpoints, sample size, and safety monitoring
  • Interpret results from clinical trials and guide future trials
  • Maintain knowledge of treatment landscapes including current treatment strategies, current and potential competitors, and new therapeutic developments

Requirements

  • MD, PharmD or PhD in the life sciences with at least 10 years of pharmaceutical or biotechnology industry experience in clinical drug development
  • Comprehensive understanding of the drug development process in all phases of testing
  • Strong scientific background, exemplified by publications and overall stature in the pharmaceutical/biotechnology industry
  • History of leading teams from discovery to clinical stages
  • Extensive experience designing, running, and managing multiple pre-clinical programs simultaneously
  • Track record of successful IND submissions and experience interfacing with regulatory agencies
  • Significant experience in designing and carrying out clinical trials
  • Experience in drafting patent applications and moving them through to issuance
  • Ability to consider new information outside of his/her area of expertise
  • Excellent communication, organizational, and interpersonal skills

Not required, but desired

  • Experience in gene therapy, enzyme replacement therapy, or gene editing
  • Experience in developing treatments for rare diseases and/or neurodegeneration

Please email CV and Cover Letter to 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

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

VP or Senior/Director of Clinical Development – NYC

The Senior/Director of Clinical Development will report to the CMO and join our newly created development team in our new offices in Midtown Manhattan.  The successful candidate will be responsible for helping to develop our clinical trial strategy, design and execution from phase 1 to phase 3 for multiple assets in Solid and Hematological malignancies.  

Responsibilities:

  • Collaborate with Chief Medical Officer to provide leadership and medical/clinical input for our programs, protocols in development and clinical trial design
  • Serve as Medical Lead for multiple assets and prioritize trials
  • Lead Medical Monitor on trials for products in development in Solid and Hematological malignancies
  • Participate and work with team members to prepare and review regulatory documents and submissions (IND and NDA)
  • Identify and build relationships with KOLs and Clinical Investigators 

Qualifications

  • MD, DO or Equivalent 
  • Board Certification or Eligibility  in Hematology / Oncology strongly preferred
  • 3-5 years Clinical Development, Drug Development experience in Pharma or Biotech
  • Demonstrated expertise in Hematology/ Oncology Clinical Development
  • Excellent oral and written communication skills
  • Ability to demonstrate flexibility and handle lean environments 

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

Successful Oncology Placements

We have been fortunate to work closely with a global biopharma to help build their commercial strategy team.  We are fortunate to work with companies making a meaningful difference in the fight to end cancer.  This company is building their global strategy as they move Immuno-Oncology therapies to market.

Contact us jobs@tseworldwide.com to help build your team!

Successful placements with global pharmaceutical company

  • Director, Clinical Development – Immunotherapies

https://wp-k1hwq7y3c2.pairsite.com/director-clinical-development-immunotherapies/

  • Director; Worldwide Oncology Commercial Strategy           

https://wp-k1hwq7y3c2.pairsite.com/director-worldwide-oncology-commercial-strategy/

  • Director; Business Development & Clinical Collaborations             

https://wp-k1hwq7y3c2.pairsite.com/director-business-development-clinical-collaborations-oncology-commercialization/

  • Director; Worldwide Strategic Analytics and Budgeting

https://wp-k1hwq7y3c2.pairsite.com/director-io-analytics/

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

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

Head of Translational Development


The candidate will be responsible for both therapeutic areas: Oncology & Immunology. As the functional head of Translational Development , they will be at the interface with the Discovery and Development teams, with the aim of providing the successful implementation of stratification strategies, clinical biomarker and pharmacodynamic assays in the early clinical development phases.


Technical Skills:

   • Collaborations that impact all of research, or even across multiple functions.
   • Scientific and technical expert.
   • Proven track record of success in drug discovery and development.

Responsibilities:

   • Cell panel screening: define resistance mechanisms, sensitivity elements, PD markers and potential biomarkers of response
   • Genomics analysis from human clinical samples, cell screen samples and clinical trial support (defined clinical experiments from the development teams). This includes development of a high dimensional bioinformatics.
   • Clinical PD or Biomarker assays, translated from discovery (if applicable or appropriate) or developed specifically for early clinical use, assessing feasibility and applicability for companion diagnostics
   • Application of model systems (in collaboration with the disease biology and in vivo pharmacology groups) beyond those routinely employed by discovery teams that aid in patient stratification/response and compound use, either        in-house or as a collaboration
   • Translational Development representation to the Development Project teams
   • Participate in formulating disease area strategy for target selection and validation
   • Evaluating, in conjunction with BD and the established teams, the potential in-licensing opportunities that may include potential therapeutics, emerging technologies, processes or capabilities that will enhance our Drug Discovery and Early Development efforts.
   • Being part of the team responsible for establishing key alliances with academic centers, co-operative groups and government agencies for cost effective implementation of  R & D and early development strategy

Qualifications:


   • Track record in large and small companies, leading innovative efforts to deploy technologies and assays for enhanced translational capabilities
   • Excellent communication, managerial and scientific qualities are expected
   • Ability to interact effectively across boundaries using influencing and relationship building skills.
   • Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals.

Other Attributes:

   • A problem solver who creatively and knowledgeably transcends departmental function to act as a resource to entire research effort and senior managers in development.
   • Identifies issues early and proposes innovative solutions.
   • Communicates within the larger organization and external community.
   • Provides expert guidance to multi-disciplinary teams and senior management.
   • A leader whose scope of influence stretches across.
   • A leader who influences external scientific community.

Requirements & Education:

   • MD, DO or PhD
   • 10 years industry experience

Associate Director, Translational Medicine – NYC

 Position Overview

The Translational Medicine Specialist is a core member of our Antigen Map team and is responsible for advancing scientific insights into viable clinical products. This leader will develop and execute translational strategies for furthering the development of next diagnostic products, with opportunities in infectious disease, autoimmunity and oncology. The successful candidate will work cross-functionally to develop a clinical development strategy across potential applications in alignment with Antigen Map team leadership. The Translational Medicine Specialist will also develop and manage clinical protocols and validation in clinical data sets that meet regulatory requirements.

Key Responsibilities

  • Serve as the dedicated translational medicine lead for the Antigen Map project
  • Help develop strategy for the Antigen Map program to ensure alignment between R&D objectives and unmet medical need
  • Support clinical development and validation of new diagnostic products
  • Develop and lead sponsored clinical protocols to test key hypotheses
  • Represent us externally and deliver scientific presentations
  • Support cross-functional teams to broaden existing and secure new clinical opportunities
  • Serve as a clinical resource to internal stakeholders such as business development, research, computational biology, marketing and sales

Experience and Skills:

  • MD with a minimum 3 years of experience, with a minimum 2 years of experience in translational and clinical research (can be Academic)
  • Deep understanding of translational research/medicine and clinical diagnostics
  • Demonstrated experience in the application various scientific technologies into translational research strategies
  • Demonstrated scientific acumen and mechanistic understanding of disease biology
  • Working knowledge of FDA guidance for the Dx and Rx industries
  • Ability to manage multiple projects and engage with diverse stakeholders in a dynamic environment within tight timelines
  • Ability to think quantitatively, interpret clinical data and interact with computational biologists and biostatisticians
  • Strong interpersonal and presentation skills, good judgment and ability to communicate with a diverse range of individuals
  • Excited about an early stage company environment and driven to make a difference
  • Strong work ethic with expectation of excellence from self and others

Head of Clinical Development – Immunotherapy and Biomarkers

Head of Clinical Development – Immunotherapy and Biomarkers

RESPONSIBILITIES

  • Provide clinical leadership and focus for R&D to ensure the creation of comprehensive product development plans from concept to launch
  • Develop actionable plans with anticipate regulatory requirements and timelines to support validation and labeling efforts
  • Provide timely product development requirements to operations which will support scaling infrastructure and capacity to support new product/market needs.
  • Experience writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis and presentation of data to internal and external audiences.
  • Ability to work in a matrix environment with other departments to include Project Management, Regulatory Affairs and Medical Affairs.
  • Excellent oral, written and personal communication skills.
  • Strong clinical research, leadership and management experience
  • Demonstrated experience leading collaborations with RA, QA, R&D, Medical and Commercial to successful product launch.

please email CV to jobs@tseworldwide.com

Genomics / Diagnostics Careers

Our genomics clients are growing rapidly and we are looking for the following:

 

  • Director – VP level candidates – Pharma Partnering; Nationally and possible EU
  • Site Head- San Francisco Bay Area and additional locations
  • VP, Translational Development – Oncology and Immunology – location open (multiple)
  • VP Clinical Development – Oncology and Immunology – location open (multiple)

For details and consideration, please send a note to tsharon@tseworldwide.com

 

 

New Opportunities and Successful Placements

Here’s a sample of our recent activity: ***Updated October-10-2019***

Open positions:

  • VP or SVP of Clinical Development- Boston Biotech 
  • COO or CBO San Francisco Biotech
  • CSO San Francisco Biotech
  • Senior Scientist-Director; DMPK
  • Director of Operations, NYC Healthcare
  • Sr/Director, IP Attorney – Boston Biotech
  • Exec Director, Late Stage Medical Lead – Rare Disease
  • Director, Field Medical Affairs – NJ
  • SVP, Head of Companion Diagnostics
  • Director, Business Development and Alliances (Field Based)
  • Head of Healthcare Product Development, San Francisco
  • VP, Cell Therapy Development, San Francisco
  • Head of Regulatory – Diagnostics
  • Boston Biotech Leadership opps – CFO, COO and CBO 
  • VP, CMC Gene Therapy – NJ
  • Director, S&E – Boston Area Biotech
  • CFO Boston Biotech
  • Director, Program Management – NJ Gene Therapy 
  • Director/AD Program Management – NJ
  • Director, Clinical Development – NYC
  • Director – Clin Ops NYC
  • Investment VP and Associate – Life Sciences Real Estate Incubator LA/NYC/Boston
  • Head of Gene Therapy Regulatory NY, NJ and Philadelphia
  • COO- Boston Biotech
  • FILLED
  • Head of Discovery, Rare Diseases, Gene Therapy
  • COO-Boston Biotech
  • CFO-NYC Biotech
  • Director, Clinical Ops, NYC
  • VP, Marketing – Pre Launch- Bay Area (FILLED)
  • VP, Market Access – Bay Area
  • VP, Commercial Analytics – Bay Area
  • VP, IT- NJ
  • VP, Banking – NYC
  • Director, Worldwide Strategic Analytics; Oncology – NJ
  • Director of BD&L and Corporate Strategy – NJ
    • Director, Business Development & Clinical Collaborations Oncology Commercialization
    • Director of Market Insights and Business Intelligence, Boston
    • A/D, Forecasting and Market Analytics-Boston
    • Manager, Healthcare Predictive Analytics
    • San Francisco -A/D of Commercial Operation, Boston
    • VP, Operations Consulting – NYC Bank -SVP, Corporate Strategy and BD
    • Sr Director, Immuno-Oncology Portfolio -Director of Commercial Strategy, Rare Diseases
    • VP, Global Medical Affairs, Rare Diseases
    • Several Strategy Consultants
    • Global Lead, Search and Evaluation
    • Lead, Global Launch / Marketing
    • Clinical Research Physician, Oncology
  • Investment Banking Associate, Healthcare M&A

Director/Sr. Director/VP Business Transformation

Our clients are looking for candidates to lead Business Transformation across billion dollar global organizations.

Responsibilities such as:

  • Conceptualize growth strategies and drive their execution
  • Make decisions that support and drive the organization strategy; build alignment within the organization to support these decisions
  • Development of change strategies and plans for accelerated implementation of new organization designs and processes

These clients include the following sectors

  • Healthcare
  • Financial Services
  • Telecom
  • Technology
  • Insurance

Site locations include: NYC, NJ, Philadelphia, Boston, San Francisco, Seattle and opportunities across Europe and Asia

Ideal candidates have 6+ years of experience in management consulting.  MBA strong preferred

Please email resume to jobs@tseworldwide.com for consideration

Head of Clinical Development – Immunotherapy and Biomarkers

  •  

    POSITION OVERVIEW

    The Vice President of Clinical Development will be responsible for establishing product requirements and development strategies for  Diagnostic Business Unit, while managing the execution of development plans for new and current products.  This important lead role will develop, plan and implement clinical research programs and trials. Lead the team to establish relevant product specification, evidence to support regulatory and payer requirements while addressing unmet clinical needs. The successful candidate will also present technology to key customers including clinical researchers, health care providers, and payers to gain engagement and support.  

    Vice President of Clinical Development will manage the allocation of personnel and financial resources to ensure the successful and timely completion of clinical product development goals.  This pivotal role will coordinate clinical product development with software development to effectively position clinical portfolio for long term success.  This hands-on leader will provide scientific expertise across the organization and drive cross-functional collaboration across all internal stakeholders while working closely with Medical Affairs. 

    RESPONSIBILITIES

    • Provide clinical leadership and focus for R&D to ensure the creation of comprehensive product development plans from concept to launch 
    • Develop actionable plans with anticipate regulatory requirements and timelines to support validation and labeling efforts 
    • Provide timely product development requirements to operations which will support scaling infrastructure and capacity to support new product/market needs.  
    • Experience writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis and presentation of data to internal and external audiences.
    • Ability to work in a matrix environment with other departments to include Project Management, Regulatory Affairs and Medical Affairs.
    • Excellent oral, written and personal communication skills.
    • Strong clinical research, leadership and management experience
    • Demonstrated experience leading collaborations with RA, QA, R&D, Medical and Commercial to successful product launch.  
    • Define and manage external partnership(s) including face to face meeting with global thought leaders
    • Interact with therapeutic partners to inform appropriate product requirements 
    • Serve as subject matter expert across the clinical portfolio to support business objectives
    • Expert communication of data in presentations at scientific conferences, either local, regional, or international
    • Create, support, present medical and scientific educational content supporting strategic plans
    • Exemplifies transparency and promotes quality of science
    • Liaise with Business Development and research functions to maximize the scope of new product development plans

    REQUIRED SKILLS, ABILITIES AND CREDENTIALS

    • Advanced degree in Life Sciences: PhD, MD, or MD PhD 
    • Strong technical background in molecular biology, genomics, next generation sequencing
    • >7 years of experience leading IVD and CLIA product development
    • Research experience in hematology, oncology or immunology with a demonstrated understanding of clinical trials addressing diagnosis, treatment of disease
    • Understanding of running clinical trials from study concept to publication
    • Excellent leadership experience in a matrix environment
    • Effective communication skills
    • Good interpersonal relationship building/maintenance
    • Ability to establish relationships and high-level customers
    • Strong presentation skills are very important
    • Excited about an early stage company environment that may require greater self-sufficiency.
    • Travel is required

please email CV to jobs@tseworldwide.com

 

Vice President, Personalized Medicine

We have multiple opportunities for Senior scientists to lead the next wave of cancer R&D for this client.

Ideal candidates have a PhD, have lead teams in product development and deep biomarker expertise.

To set up an exploratory, discussion, please email jobs@tseworldwide.com