Executive Director, Global Marketing Cell Therapy Franchise

Executive Director, Global Marketing Cell Therapy Franchise

(Executive Director, Marketing)

The Executive Director, Global Marketing Franchise will play a key role on the global marketing cell therapy team.  This role will have primary responsibilities for optimizing the global environment to ensure commercial success of all Kite assets.  This role will work in close collaboration with the global marketing cell therapy brand leads and global cross functional and regional teams to develop and globally support the implementation of a Kite cell therapy franchise position, develop a global growth strategy for the CAR T class.  In addition, this role will lead the global cell therapy commercial policy and publication efforts to optimize the global environment to support Kite brands to reach their fullest potential. 

Key Responsibilities

  • Develop the global cell therapy growth strategy for the CAR T class; working in close partnership with global brands leads to ensure alignment with individual brand strategies
  • Develop the global cell therapy franchise strategic plan with core franchise deliverables in alignment with Kite leadership positioning
  • Identify key areas of global commercial cell therapy policy (i.e. institutional capacity planning, ethical considerations in cell therapy commercialization, academic CAR T, etc) and work cross functionally to develop a strategic plan to enhance global awareness and/ or drive global policy change providing local communication toolkits
  • Work in close collaboration with international cell therapy opinion leaders to gain insight, understanding and alignment on key policy issues within cell therapy
  • Develop  global congress strategy with cross functional and cross regional alignment
  • Work in close partnership with brand leads to assess local affiliate business cases and ensure global launch sequence standards
  • Develop and implement ongoing strategic planning training plan
  • Work in partnership with key organizations (ARM, EBMT, ASTCT. ASGCT) to identify strategic priorities and develop forward thinking global cell therapy policy
  • Develop global strategy to enhance commercial publications on key cell therapy policy issues
  • Develop global toolkits with commercial policy key message points and supporting insights that can be leveraged locally to drive Kite commercial policy positions with external audiences globally

Qualifications:

The ideal candidate will have 5-10+ years of experience working cross functionally at specialty-focused pharmaceutical or biotechnology companies, with significant experience in Hematology.  Prior experience in cell therapy is a plus.  

The ideal candidate will possess experience working at both a global and affiliate/ local marketing level, achieving success with both long term strategic development and short term tactical implementation.

The ideal candidate will also have experience developing policy principles and action plans to support optimal global policy development. 

Candidates must have an undergraduate degree in marketing or related fields with a post-graduate degree preferred. 

Additional qualifications include:

  • A motivational leadership style with strong business and commercial acumen that has demonstrated success in managing and growing a business
  • Comfort with uncertainty and developing innovative new pathways with rapid timelines and high expectations 
  • Ability to exercise sound judgment and independently determine appropriate action where precedent may not exist
  • Strong leadership skills within a large matrix organization ; ability to navigate complex business structures 
  • An approachable and credible communication style, both verbally and written, to keep all levels of the organization informed and engaged
  • Ability to work collaboratively with cross-functional teams, synthesizing diverse perspectives into cohesive, aligned recommendation/deliverables, managing dissension along the way and championing team recommendations
  • Demonstrated ability to think strategically and align and engage both internal and external stakeholders to drive performance
  • Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
  • Ability to understand the science and data; be effective at leveraging analytics and leading within a science-driven commercial model
  • An established role model of Gilead/Kite core values and ways of working that inspire high performance culture and engagement

Please email resume to jobs@tseworldwide.com for consideration 

Director, Global Marketing Franchise

The Director, Global Marketing Franchise (Director, Marketing) will play an important role on the global marketing cell therapy team. This role has responsibility for assisting in the development and implementation of global disease strategies and global asset strategic and tactical plans.  This role works in close collaboration with the global marketing cell therapy brand and commercial operations leads and the global cross-functional and project teams.  This role reports into the VP, Global Marketing and is based in California.

Key Responsibilities

  • Facilitate the execution of the global brand and commercial operations strategic plans; oversee key elements of the global implementation plans
  • Ensure agile execution and refinement of the global plans by enabling real time monitoring and evaluation of competitive products and marketplace dynamics
  • Lead the implementation of core global tactics ensuring cross functional and global input with timely execution of global deliverables
  • Effectively partner with global and affiliate marketing, medical and market access colleagues to ensure the value of key deliverables
  • Initiating relevant Market Research projects to inform strategic brand plans, and KPI tracking
  • Serve as a core member of key cross functional teams
  • Responsible for coordinating various aspects of key global conferences for example organizing global events, contributor to global congress team.
  • Collaborating with the brand leads to set assumptions for and validate global sales and resources forecast and working closely with the country finance teams.

The ideal candidate will have 5+ years of global and/ or local hematology/ oncology marketing experience at a specialty-focused pharmaceutical or biotechnology companies.  Prior experience in cell therapy is a plus.  

The ideal candidate will possess experience working at both a global and affiliate/ local marketing level, achieving success with both long term strategic development and short term tactical implementation.

Candidates must have an undergraduate degree in marketing or related fields with a post-graduate degree preferred. 

Additional qualifications include:

  • A Bachelor’s degree in marketing or related fields is required.
  • An advanced science degree such as MD, PharmD, PhD or an advanced business degree such as an MBA is desirable
  • Ability to coordinate with regional and local market teams to collect markets inputs into strategy development and support local implementation of global strategy
  • Comfort with uncertainty and demonstrated ability to exercise sound judgment under tight timelines and independently determine appropriate action where precedent may not exist
  • Leadership skills within a large matrix organization ; ability to navigate complex business structures 
  • An approachable and credible communication style, both verbally and written, to keep all levels of the organization informed and engaged
  • Demonstrated ability to think strategically and align and engage both internal and external stakeholders to drive performance
  • Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
  • Ability to understand the science and data; be effective at leveraging analytics and leading within a science-driven commercial model

Please email resume to jobs@tseworldwide.com for consideration 

Associate Director, Primary Market Research

The Associate Director, Primary Market Research will be responsible for leading primary market research efforts in supporting strategic and tactical decision making with insightful analysis to maximize the potential of Kite’s pipeline and approved cell therapies. As a strategic partner, the role involves collaborating with marketing, customer engagement, market access, and customer facing teams to shape the design/strategy of critical market research and analytical projects. The person in this role will be responsible for working independently to identify, prioritize and find solutions for the key market research needs of the commercial organization. This position reports to the Director, Global Marketing Analytics, and is based in Santa Monica, CA.

Key Responsibilities:

  • Define market research priorities in collaboration with rest of the commercial organization
  • Ensure successful execution of qualitative and quantitative market research studies with physicians, patients, and payers. Integrate results of market research, latest competitive intelligence, as well as secondary analytics into actionable insights
  • Create foundational market understanding through the development of treatment flow maps, market segmentation, attribute/benefit testing, positioning and campaign development, etc.
  • Support early asset commercial planning through opportunity assessments and market landscape research
  • Support brand planning process by providing an objective and detailed understanding of current market dynamics, product performance, customers, and competitors
  • Inform forecast assumptions by executing conjoint demand study and other demand estimation related research
  • Manage vendors to determine appropriate research methodology, ensure project alignment to business objectives and guide execution and reporting

Qualifications:

  • Bachelor’s Degree. MBA or other related graduate-level degree is a plus
  • 6 or more years of work experience in market research, marketing sciences, strategic consulting or other analytical work in the biotech / pharmaceutical industries in leadership roles with direct management experience
  • Previous experience in oncology/hematology is required
  • Track record of delivering actionable insights through successful execution of qualitative and quantitative market research projects, as well as strategic problem-solving skills
  • Exceptional ability to manage multiple projects in a fast-moving entrepreneurial environment, with changing priorities and significant time pressures
  • Strong communication skills (both verbal and written) required. Demonstrated ability to collaborate and work cross-functionally
  • Ability to develop and maintain strong team, including external partners, relationships while driving for positive results
  • Possess a willingness and ability to work hands-on and with a sense of urgency
  • Extensive proficiency with Microsoft Office (Word, Excel, PowerPoint and Outlook)

Please email resume to jobs@tseworldwide.com for consideration 

Director, Global Marketing X19


Director, Global Marketing X19 (Director, Marketing)

The Director, Global Marketing X19 will play a key role on the global marketing cell therapy team.  This role will have primary responsibility for ensuring world market optimization to support X19 to reach its fullest potential.   This role will create and implement global commercial strategic and tactical plans over the life cycle of X19 for existing and future indications.   This role will work in close collaboration with the global marketing franchise and brand leads as well as with the global cross functional and project teams to ensure world market preparation for the successful launch of X19.

Key Responsibilities

  • Develop, in close collaboration with cross functional partners, the strategic launch plan for X19 to maximize it’s potential globally; including the development of  global launch toolkits with positioning, messaging and core creative in alignment with franchise positioning
  • Work with legal, regulatory, medical affairs, clinical and other partners to ensure the cross functional alignment of the proposed strategy
  • Work in close collaboration with global X19 brand leads to develop post launch performance metrics and global dashboards and share key learnings across global launches
  • Manage and coordinate global commercial tactical deliverables
  • Work in partnership to ensure alignment of X19 global forecast assumptions
  • Develop partnerships with key external stakeholders in Lymphoma and CAR T
  • Monitor the CAR T and disease area competitive environment to develop insights and identify opportunities and threats
  • Work in partnership with Gilead colleagues to ensure strong global marketing alignment

Qualifications:

The ideal candidate will have 5+ years of experience leading teams of marketing professionals at specialty-focused pharmaceutical or biotechnology companies, with significant experience in Hematology/Oncology.  Prior experience in cell therapy is a plus.   

The ideal candidate will possess experience working at both a global and affiliate/ local marketing level, achieving success with both long term strategic development and short term tactical implementation.

Candidates must have an undergraduate degree in marketing or related fields with a post-graduate degree preferred.  Additional qualifications include:

  • Strong business and commercial acumen that has demonstrated success in managing and growing a business
  • Comfort with uncertainty and developing innovative new pathways with rapid timelines and high expectations 
  • Ability to exercise sound judgment and independently determine appropriate action where precedent may not exist
  • Strong leadership skills within a large matrix organization ; ability to navigate complex business structures 
  • An approachable and credible communication style, both verbally and written, to keep all levels of the organization informed and engaged
  • Ability to work collaboratively with cross-functional teams, synthesizing diverse perspectives into cohesive, aligned recommendation/deliverables, managing dissension along the way and championing team recommendations
  • Demonstrated ability to think strategically and align and engage both internal and external stakeholders to drive performance
  • Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
  • Ability to understand the science and data; be effective at leveraging analytics and leading within a science-driven commercial model
  • An established role model of Gilead/Kite core values and ways of working that inspire high performance culture and engagement

Please email resume to jobs@tseworldwide.com for consideration 

Associate Director, Global Forecasting & Marketing Analytics

The Associate Director, Global Forecasting & Marketing Analytics will be responsible for leading forecasting efforts in supporting strategic and tactical decision making with insightful analysis to maximize the potential of breakthrough cell therapies. As a strategic partner, the role involves collaborating with cross functional teams, including leaders in commercial, FP&A, supply chain, and other corporate functions. The person in this role will be responsible for working independently to identify, prioritize and find solutions for the key forecasting and analytical needs of the commercial organization. He/she will oversee (and at times directly execute) forecasting, secondary data analysis and other analytics projects.

Key Responsibilities:

  • This highly visible role will lead the development and process execution of Long Range (LRP) forecasts for marketed and pipeline products as well as ad-hoc requests including commercial assessment of business development opportunities
  • Independently design, prepare and maintain long range global forecasts models. Leverage primary/secondary research insights and team inputs to create robust assumptions and forecast inputs. The forecaster will produce analogues, formulate assumptions, and define opportunities and risks associated with the forecast. 
  • Work closely with regional forecasting and commercial teams to ensure consistency in forecast structure and comparability between key commercial assumptions
  • Perform ad-hoc and scenario modelling using long-term models to support decision-making by Commercial, R&D, Corporate Development, Finance, and Corporate executive leadership
  • Work with regional Market Research group to help scope and design quantitative market research (e.g., discrete-choice conjoint) to inform revenue forecasting via predictive patient share modelling
  • Collaboration: Partner closely with FP&A, supply chain and other corporate functions to design and execute an effective S&OP process, to build and drive quarterly revenue reconciliation.
  • Strategic Projects: Drive analytics for planned and ad hoc strategic projects including scenario analysis to help drive key decisions for the business.

Qualifications:

  • Bachelor’s Degree. MBA or other related graduate-level degree is a plus
  • 6 or more years of work experience in forecasting, marketing sciences, market research, strategic consulting or other analytical work in the biotech / pharmaceutical industries in leadership roles with direct management experience
  • Previous experience in oncology/hematology is required
  • Track record of delivering actionable insights through successful execution of forecasting and marketing analytics projects, as well as strategic problem-solving skills
  • Exceptional ability to manage multiple projects in a fast-moving entrepreneurial environment, with changing priorities and significant time pressures
  • Strong communication skills (both verbal and written) required. Demonstrated ability to collaborate and work cross-functionally
  • Ability to develop and maintain strong team, including external partners, relationships while driving for positive results.
  • Possess a willingness and ability to work hands-on and with a sense of urgency
  • Extensive proficiency with Microsoft Office (Word, Excel, PowerPoint and Outlook) and forecasting software (e.g., Crystal ball, Forecast Pro, customized platforms)

Please email resume to jobs@tseworldwide.com for consideration 

Director, Global Customer Experience

Director, Global Customer Experience (Director, Marketing)

The Director, Global Customer Experience, will play a key role on the global marketing and customer experience team.  This role will have primary responsibility for ensuring the successful global design, development and launch of key aspects of the ecosystem while additionally leading key digital customer experience development projects.  This role will work closely with the key affiliates, technical operations and information technology.

Key Responsibilities

  • Global design, development and execution of key aspects of the ecosystem
  • Key contact for local  affiliate partners for commercial operational readiness
  • Assess business needs for new portal launches; develop customer insight guidelines to optimize customer feedback through primary market research and informal discussions with customers
  • Identify Business Requirements for Kite Konnect Ecosystem
  • Leader of the head office cross functional team to ensure global Kite Konnect implementation
  • Key partner to technical operations/ supply chain team to ensure alignment
  • Key contributor to the ongoing development/ enhancement of the Kite commercial operations customer experience
  • Represent Kite Konnect in strategic planning sessions as part of the G3MO team and with cross functional planning teams
  • Key member of the Kite Konnect Governance Committee to cross-functionally and cross-geography prioritize enhancements, share best practices and facilitate partnerships in efficiency across the organization
  • Represent Commercial Operations needs and requirements to cross-functional planning teams
  • Work with cross-functional partners from legal, US Marketing, Commercial Operations and others to refine the needs to internal and external stakeholders

Qualifications:

The ideal candidate will have 5+ years of global commercial / digital experience at specialty-focused pharmaceutical or biotechnology companies. Experience with commercial operations or customer experience with comfort in digital commercial/ customer platforms is ideal.

The ideal candidate will possess experience working at both a global and affiliate/ local marketing level, achieving success with both long term strategic development and short term tactical implementation.

The ideal candidate will also have experience with digital commercial / customer platforms.

Experience leading the design and implementation of global launches and / or transformational business initiatives within global markets will be considered a strong benefit.

Candidates must have an undergraduate degree in marketing or related fields with a post-graduate degree preferred.  Additional qualifications include:

  • A motivational leadership style with strong business and commercial acumen that has demonstrated success in managing and growing a business
  • Comfort with uncertainty and developing innovative new pathways with rapid timelines and high expectations 
  • Ability to exercise sound judgment and independently determine appropriate action where precedent may not exist
  • Strong leadership skills within a large matrix organization ; ability to navigate complex business structures 
  • An approachable and credible communication style, both verbally and written, to keep all levels of the organization informed and engaged
  • Ability to work collaboratively with cross-functional teams, synthesizing diverse perspectives into cohesive, aligned recommendation/deliverables, managing dissension along the way and championing team recommendations
  • Demonstrated ability to think strategically and align and engage both internal and external stakeholders to drive performance
  • Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
  • An established role model of Gilead/Kite core values and ways of working that inspire high performance culture and engagement

Please email resume to jobs@tseworldwide.com for consideration

Associate Director, Global Commercial Project Management

The Associate Director, Global Commercial Project Management is responsible for providing project management support to multiple global commercial strategy teams

Responsibilities:

  • Work in partnership with brand and customer experience strategy leads to develop, gain approval, and execute on the global commercial strategies
  • Manage the G3MO steering committee agendas, minutes and action items in alignment with the G3MO steering committee co-chairs
  • Manage the G3MO franchise meetings for the strategy teams; including ongoing coordination across the commercial strategy teams
  • Work to ensure timely, efficient, and action-oriented G3MO  meetings and responsible for coordinating team operations and communications.
  • Develop communications and presentations related to strategy, status, critical path activity timing, resources required, and related issues and / or risks, and communicate internally and to external partners as appropriate
  • Ensures delivery of high quality integrated cross functional project plans, effective management of project activities, and control of project timelines
  • Create and maintain tools for internal and external communication about project goals and progress (dashboards etc.)
  • Partner with key partners to champion continuous improvement, new ideas, and initiatives that drive corporate programs
  • Directs project communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status
  • Provides input into periodic project reports, budget reforecasts etc.

Qualifications:

The ideal candidate will have 5+ years of commercial project management experience at specialty-focused pharmaceutical or biotechnology companies.

Candidates must have an undergraduate degree in marketing or related fields with a post-graduate degree preferred.  Additional qualifications include:

  • Project Management certification or equivalent is a plus
  • Experience should include prior participation in cross-functional project management activities.
  • Must be able to understand and effectively communicate both scientific and business related ideas/concepts
  • Must possess excellent interpersonal, organizational, written and verbal communication skills along with ability to work collaboratively in a team environment
  • Must be able to support highly complex multiple activities simultaneously
  • Must be able to work independently under minimal supervision, develop and drive a personal work plan, and manage/prioritize time effectively
  • Able to express ideas and present information effectively within teams, functions, and with external partners
  • Demonstrate/Provide active listening and feedback within team, ability to facilitate problem solving, decision making, and issue resolution
  • Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and Microsoft Office Suite
  • Strong program management skills
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced, dynamic, and highly fluid company environment with minimal guidance and able to adjust workload based upon changing priorities

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

VP, CMC – Boston, Philadelphia, NJ, SF

Reporting to the Chief Portfolio Officer (CPO) and Head of Gene Therapy, the Vice President, Gene Therapy CMC will lead a team focused on CMC development of the gene therapy portfolio.  This individual will be a senior leader in the organization and contribute to the company’s research and development efforts to create high value gene therapies to address unmet medical needs for devastating rare diseases. The position will be based out of one of locations in the central NJ/Philadelphia area with laboratory facilities. 

This role is seen as a critical addition to the existing Tech Ops organization currently responsible for overseeing CMC product strategy development and execution of gene therapies, as well as overseeing the complex global network of partners who manufacture and supply clinical and commercial products.  

ROLES AND RESPONSIBILITIES

Primary responsibilities include:

  • Lead, define and build the broad gene therapy technical development and manufacturing strategy with members of the Technical Leadership Team, and  Gene Therapy Leadership Team 
  • Lead the multi-functional team responsible for the development and execution of comprehensive and integrated technical development plans for product portfolio
  • Coordinate and align with the Global Supply Chain leadership to implement the gene therapy supplier network strategy 
  • Direct the design, development, scale-up, and technology transfer of gene therapy manufacturing processes from feasibility test, pilot plant through manufacturing scale
  • Responsible for process development and provides support for process validation in accordance with regulatory guidance
  • Manage the development, implementation, and support of production processes, analytics, control methods and equipment to achieve stage appropriate production of preclinical test article, and early stage clinical trial material
  • Represents the Technical Operations function as a member of the cross-functional Gene Therapy Leadership Team (GTLT) providing strategic guidance to R&D Steering Team on the gene therapy programs and business
  • Work seamlessly with functional and cross functional stakeholders such as Research, Program Management, Alliance Management, Project Management, QC, QA, Regulatory, Manufacturing, Supply Chain and Manufacturing Science & Technology and external collaborators to help advance the portfolio programs through development
  • Key decision influencer on complex issues where analysis of situations and data requires an in-depth knowledge of process development and engineering, factors influencing scale up / scale down of critical process parameters and pharmaceutical production equipment
  • Has accountability for the technical, operational and financial performance of the Technical Development department
  • Is accountable for the alignment of the departmental activities with the activities of the peer departments
  • Provides overall direction to the function and is accountable for departmental deliverables
  • Works with the SVP, Tech Ops and the peer department heads to actively contribute to the gene therapy activities within Tech Ops
  • Coordinates with  the SVP, Tech Ops and the CPO & Head of Gene Therapy to develop and communicate strategic and tactical direction of CMC Development
  • Is recognized as a thought leader internally within and externally within peer communities and uses reputation to enable successful performance of the department
  • Select, develop, and evaluate personnel to ensure the efficient operation of the function
  • Represents the department internally/externally
  • Able to gather internal/external benchmarks for best practices in the scientific field
  • Other responsibilities/activities as may be assigned

ORGANIZATIONAL STRUCTURE

Dual reporting to the Senior Vice President, Technical Operations and CPO and Head of Gene Therapy

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements

  • Ph.D. in engineering or life sciences

Professional Work Experience 

  • 5+ years direct leadership experience in gene therapy CMC development and manufacturing, bioprocess development or related areas
  • 10 – 15 years of experience of CMC development experience  
  • Experience managing a broad organization, as a leader of leaders
  • Experience with external manufacturing providers, partners, and/or academic collaborations is required
  • Demonstrated ability to successfully manage biologics/gene therapy  programs through technical development, including QbD process characterization and validation, is required
  • A keen ability and desire to grow an organization, mentor our next level leaders, and help manage the dynamics of change
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • A passion for addressing the critical unmet medical needs of patients

To apply please email resume to jobs@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

Director, Program Management

SUMMARY OF POSITION

The Director, Program Management is the operational lead for a clinical stage program to ensure that program and corporate goals are met on time, within budget and with high-quality results.  Using solid program management knowledge and broad experience in drug development, the Associate Director, Program Management will partner with the relevant Medicines Lead to create development plans, but be directly responsible for the day-to-day, cross-functional execution of those plans.This role will support the Medicines Lead for Rare Disease.

MAJOR ACTIVITIES AND RESPONSIBILITIES

  • Supportive Leadership: Provides operational support and leadership and overall direction to cross-functional teams.
  • Planning, Documenting and Tracking: Facilitates achievement of strategic goals for a program by proactively planning tasks, documenting meeting outcomes including actions and decisions, and monitoring ongoing progress of deliverables.
  • Risk Identification, Mitigation and Communication: Scans workstreams to identify potential risks, develop mitigation plans and communicate these in a timely fashion to the cross-functional team and the Medicines Lead.
  • Budget Management:  Maintains spend levels in line with board-approved budget, supports contract request process from teams as needed.
  • Governance and Continuous Improvement: Ensures key recommendations flow through the Core Team, various Matrix Teams, and appropriate governance committees in the right order to ensure vertical and horizontal integration across functional areas and senior management. Identifies and analyzes problems, and recommends solutions to rest of Program Management as part of continuous improvement.
  • Communication: Ensures effective, accurate and timely communication of key issues and progress to the Medicines Lead, program team members, and other functions or governance committees as appropriate.
  • Other responsibilities may be assigned as required.

REQUIREMENTS

  • BS/MS in life sciences required; Advanced degree (PhD, MBA) preferred.
  • PMP certification preferred.
  • Minimum of 5 years of relevant program management experience in drug development managing clinical stage programs (Ph 1 – 3).  Other functional experience in drug development preferred (e.g. Clinical Operations, Regulatory Operations, Technical Operations, etc.).
  • Experience in marketing authorization submissions and approvals in Europe, U.S., Japan a plus.
  • Facility with tools and technology including MS Project/Powerpoint/Excel, SharePoint, teleconferencing platforms preferred.

EXPERIENCE AND SKILLS 

  • Excellent interpersonal, verbal and written communication skills.  
  • Able to work effectively in a cross-functional environment.
  • Detail-oriented and highly organized.
  • Works independently and under tight deadlines.
  • Comfort with ambiguity.
  • Able to resolve conflicts in a positive and collaborative manner.
  • Constantly looks for ways to improve (processes, own behaviors)
  • Able to manage up and down.
  • Self-awareness.

TRAVEL 

  • The role for may require up to 25% travel, both domestic and international.

Vice President, Process Development; Cellular Assays

Position Overview:

The Vice President (VP) of Product Development will be responsible for state-of-the art cellular immunology laboratory process and product development requirements. This key role will lead the transition of T-cell receptor (TCR) discovery workflows from research and proof-of-concept to the next product development stage. The VP of Product Development is accountable for implementing end-to-end TCR screening and characterization workflows, assay validations and standardization. S/he will implement GLP-compliant processes, production-level controls, drive assay / method validations, maintain all necessary documentation, and evaluate workflow changes that could affect the production and control of a TCR product. The VP of Development will put in place strategies to scale cellular immunology laboratory and support the development of IND-ready products.  This key leadership role will support corporate-level Drug Discovery goals.

Job Responsibilities:

  • Evaluate current cellular immunology and workflows, assays (e.g., TCR binding, cell killing and safety) and processes. 
  • Transition research-based workflows into product and process development under GLP conditions. 
  • Lead product development strategy and establish TCR product validation and development plans, including product characterization and safety evaluation. 
  • Maintain relevant requisite TCR screening and product controls plus validation data. 
  • Develop and maintain detailed reports containing TCR screening and characterization development methods. 
  • Lead efforts to inform the development of real-time, patient-specific TCR screening process for a future fully personalized TCR-based cellular therapy. 
  • Coordinate cross-functionally with R&D, Operations and leadership to provide timely product development needs that inform infrastructure or resource requirements.

Experience and Skills:

  • Advanced degree in Life Sciences: PhD, MD, or MD / PhD. 
  • Strong background and experience in biologics process validation and product development. 
  • Experience in cellular immunology / biology is preferred. 
  • >7 years of experience leading product development. 
  • Demonstrated understanding of assay and product development requirements. 
  • Ability to work in a matrix environment and leverage cross-functional resources. 
  • Ability to function autonomously and drive strategic decisions. 
  • Team leader with the ability to work and manage others. 
  • Ability to work effectively with senior-level stakeholders, internally and externally. 
  • Strong communication and interpersonal skills and good judgment. 
  • Independent strategic thinker with strong ability to solve complex problems. 
  • Excited about an early stage company environment and driven to make a difference.

Sr. Director/VP – Cell Therapy Discovery

Position Overview:

The Sr. Director of Cell Therapy Development will be responsible for establishing therapeutic product requirements and develop IND-enabling strategies for our Drug Discovery group. The Sr. Director of Cell Therapy Development will develop, plan and implement product requirements to inform clinical programs for T cell receptor based cell therapies plus any potential future drug modalities to be developed. S/he will establish product efficacy and safety specifications. In the near-term, this role will focus on informing robust TCR data packages for IND submissions and IND-enabling clinical trials.

This key role within R&D will guide the cellular therapy product development strategy and successfully enable us to achieve its Drug Discovery clinical development goals.

Job Responsibilities:

  • Lead IND-enabling strategy and establish TCR-based cellular therapy development plans. 
  • Inform clinical Target Product Profile (TPP) and develop IND-enabling TCR data packages. 
  • Support R&D efforts to ensure the creation of comprehensive product development plans. 
  • Support communications to fulfill regulatory authority requirements and address inquiries (e.g. Pre-IND meetings, IND questions and answers). 
  • Lead the development of product characterization; maintain relevant requisite product controls. 
  • Develop reports to support regulatory submissions/filings. 
  • Track and report any significant changes to the TCR discovery process / methods that may require amendments to regulatory materials or impact future manufacturing process and product development. 
  • Lead efforts to inform framework for real-time, patient-specific TCR screening, including immune monitoring during clinical trials. 
  • Provide timely product development requirements that inform new product/clinical needs. 
  • Write and implement development protocols, review and interpret data.

Experience and Skills:

  • Advanced degree in Life Sciences: PhD, MD, or MD PhD. 
  • Strong background and experience in biologics product development. 
  • Experience in cellular immunology/biology and cellular therapy product development. 
  • >5 years of experience leading biologics product development. 
  • Demonstrated understanding of IND-enabling product requirements and product launch. 
  • Ability to work in a matrix environment and leverage cross-functional resources. 
  • Ability to interact strategically with drug discovery partners to inform product requirements. 
  • Ability to function autonomously and drive strategic decisions. 
  • Team leader with the ability to work and manage others. 
  • Ability to work effectively with senior-level stakeholders, internally and externally. 
  • Strong communication and interpersonal skills and good judgment. 
  • Independent strategic thinker with strong ability to solve complex problems. 
  • Excited about an early stage company environment and driven to make a difference.

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

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

Director, Program Management –NJ

Director, Program Management – Gene Therapy

Summary of Position

The Director, Program Management will support preclinical and/or clinical programs. The Director will be responsible for driving strategy and cross-functional execution on key program work streams, as well as for managing overall program timelines and budgets to support achievement of relevant corporate and program milestones. This role will contribute to the development plan and budget for the franchise.  In addition to these preclinical/clinical program responsibilities, the Director, Manager of Program Management will help support the Head of R&D Program Management with other initiatives as needed, and will contribute to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Roles and Responsibilities

  • Working closely with the Head of R&D Program Management and Discovery area leaders to manage development and execution of overall global strategy for the preclinical programs
  • Contributing to timely execution of program activities including anticipating and identifying project risks, mitigations and contingencies, and supporting timely action plans and issue resolution
  • Ensuring effective communication to align program activities with corporate strategy, and ensure effective program execution
  • Partnering with functional team members to monitor program spend against budget, and to develop project scenarios for decision making
  • Using key project management tools to enhance project and program delivery and information dissemination to the team and key stakeholders
  • Ensuring effective program team meetings, logistics and documentation
  • Contributing to development and review of corporate communications
  • Supporting other initiatives as needed
  • Contributing to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Qualifications and Background Requirements

  • A degree in the life sciences is desirable
  • An advanced degree in the life sciences, MBA or management consulting experience is desirable
  • Formal training in program/project management (e.g. PMP certification) is a plus
  • 6+ years of development experience in the pharmaceutical/biotech industry (with drug substance/drug product manufacture, preclinical, analytical, quality, clinical, and/or regulatory), of which 3+ years in program management
  • Strong interpersonal and communication skills for effective collaboration
  • Solid organizational skills including high attention to detail and ability to multi-task
  • Strong business acumen
  • Previous project management experience
  • In-depth experience with project management tools

Please email resume & cover letter to jobs@tseworldwide.com

Associate Director, Program Management – Gene Therapy

Associate Director, Program Management – Gene Therapy

Summary of Position

The Associate Director, Program Management will support preclinical and/or clinical programs. The Associate Director will be responsible for driving strategy and cross-functional execution on key program work streams, as well as for managing overall program timelines and budgets to support achievement of relevant corporate and program milestones. This role will contribute to the development plan and budget for the franchise.  In addition to these preclinical/clinical program responsibilities, the Associate Director, Manager of Program Management will help support the Head of R&D Program Management with other initiatives as needed, and will contribute to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Roles and Responsibilities

  • Working closely with the Head of R&D Program Management and Discovery area leaders to manage development and execution of overall global strategy for the preclinical programs
  • Contributing to timely execution of program activities including anticipating and identifying project risks, mitigations and contingencies, and supporting timely action plans and issue resolution
  • Ensuring effective communication to align program activities with corporate strategy, and ensure effective program execution
  • Partnering with functional team members to monitor program spend against budget, and to develop project scenarios for decision making
  • Using key project management tools to enhance project and program delivery and information dissemination to the team and key stakeholders
  • Ensuring effective program team meetings, logistics and documentation
  • Contributing to development and review of corporate communications
  • Supporting other initiatives as needed
  • Contributing to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Qualifications and Background Requirements

  • A degree in the life sciences is desirable
  • An advanced degree in the life sciences, MBA or management consulting experience is desirable
  • Formal training in program/project management (e.g. PMP certification) is a plus
  • 6+ years of development experience in the pharmaceutical/biotech industry (with drug substance/drug product manufacture, preclinical, analytical, quality, clinical, and/or regulatory), of which 3+ years in program management
  • Strong interpersonal and communication skills for effective collaboration
  • Solid organizational skills including high attention to detail and ability to multi-task
  • Strong business acumen
  • Previous project management experience
  • In-depth experience with project management tools

Please email resume & cover letter to jobs@tseworldwide.com

Executive Director, Rare Disease Product Development

Executive Director, Product Development, Bay Area

Product Development is responsible for corporate and R&D governance, business operating model (core teams and sub-teams) and portfolio strategy. Product Development integrates overall product strategy and ensures planning and timely execution to inform decision making and development of therapies .

Role:

Product champion and leads a team of core functional leaders that together help develop product strategy and planning for clinical and/or marketed products. You will be the primary liaison between team/sub-teams and executive management and has overall accountability to executive management (CEO and CEO leadership team) for the integrated product strategy. In collaboration with core team (CT) members, ensures progress and execution against plans and as the leader of the CT is the primary contact for internal stakeholders. As a senior leader in the core team leader group, is a role model, mentors peers and contributes to key core team processes and initiatives.

Key Responsibilities:

Program Strategy
Lead the CT in the generation of a Target Product Profile and the cross-functional compound development and lifecycle strategy taking into account global considerations
Lead CT and develop forward looking integrated stage based product development plans that are aligned with program strategy and ensures assumptions and drivers are aligned with plans to inform financial planning
Lead efforts in partnership with line functions to optimize value of the compound throughout its lifecycle.
Ensure potential risks are identified and contingency planning with a solutions focused mindset.
Team Effectiveness
Ensure cross functional partnerships and resources are leveraged effectively, and with accountability, to achieve program objectives.
Drive collaboration and transparency across all functions on the CT and challenge team members to be broad and inclusive in their strategy planning.  
Resolve conflicts at the Core Team, provide and receive feedback to develop and maintain a high performing team and if necessary escalate team member performance related issues to functional management
Governance and Approvals
Ensure that team recommendations are brought to appropriate governance for management buy-in and decisions
Ensure alignment of program strategy/plan/execution with management expectations & priorities
Lead CT in the development of scenarios and recommendations and present CT position for decision making at various governance bodies. Leverage SMEs for expertise and have SMEs present on topics pertaining to their areas
Communication
Single point of contact on program for executive and functional management
Ensures communication of rationale and context for decisions made to team
Leads team in developing a comprehensive internal and external communication plan with team input for important program milestones, key data, etc.
Reviews and agrees to publication plan, reviews publication concepts, presentations and manuscripts
Primary source for information as needed for external communications (press releases, investor related, etc.)
Reviews health authority related documents and ensures consistency with strategic objectives for the program
In partnership with Project Management Lead, CTL ensures
Timely progress and execution against strategy and plans
Timely and aligned input into drivers for LRP and Budget process
Requirements

Education:

The successful candidate will ideally have an advanced degree in a scientific discipline (e.g., Ph.D. or M.D.); M.B.A. is a plus.

Experience:

15+ years (Executive Director) or 12+ years (Senior Director) experience in the biotechnology/ pharmaceutical industry. Ideally, the individual will have experience in drug development across several therapeutic areas and across the spectrum of drug development and life cycle management.
Experience as a leader of product or compound strategy teams or sub-teams. Experience leading a core/cross functional strategy team for an investigational therapy through development is preferred.
The successful candidate will also demonstrate strong leadership ability and professional credibility to influence a highly intelligent and sophisticated audience of colleagues, partners, and external constituents.
This individual must be a self-starter and possess excellent leadership, influencing and communication skills, as they will be applied at all levels, including at the core team, interactions with the executive team, and presentations to high-level internal and external audiences

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

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