What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?
Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.
Position Summary:
The Clinical Development Lead (Medical Director or Senior Medical Director level) is a Physician-Scientist who plays a pivotal role on Pioneering Medicines (PM) project teams by driving the successful transition of programs from research into early clinical development. Reporting to the SVP of Project Leadership and Development (or a senior Clinical Development Leader), this role contributes to shaping clinical strategies that span from candidate discovery to human proof-of-concept (hPOC).
As a core member of cross-functional teams, the Clinical Development Lead is responsible for crafting and integrating the target product profile and clinical development plans in alignment with research, translational, nonclinical, regulatory, and strategic priorities. This individual will also support program operations, resource planning, and interactions with internal governance and external partners. The role is ideal for an individual passionate about translating cutting-edge science available from across the Flagship Pioneering ecosystem of companies into innovative medicines through rigorous, thoughtful, and collaborative development planning.
This role can be onsite at our Cambridge MA site (4 days onsite per week) or remote for candidates outside a 30-mile radius from Cambridge MA.
Responsibilities:
- Lead the design of early clinical development plans (through hPOC) for PM programs, in alignment with the Target Product Profile (TPP)
- Collaborate closely with the senior clinical leaders, Project Leaders, Research, Strategy, and external advisors/KOLs to define and refine clinical hypotheses and development strategies.
- Integrate clinical plans with translational, nonclinical, and regulatory development strategies to enable seamless progression from exploratory studies to FIH trials.
- Partner with Research teams—including Pharmacology, Translational Sciences, and Nonclinical Development—to align research outputs with clinical objectives.
- Work with the Strategy Group to ensure clinical plans support the TPP and the overall program value proposition.
- Incorporate regulatory input, operational feasibility, and real-world data to ensure robust and executable development strategies.
- Collaborate with Project Management to develop integrated timelines, resource forecasts, and budget assumptions for incorporation into NewCo planning.
- Support the preparation and delivery of key materials for internal governance forums and Joint Steering Committees (JSCs) with external partners.
- Identify and address development risks and bottlenecks proactively; drive resolution across functional interfaces.
- Promote a culture of scientific rigor, accountability, agility, and open collaboration within project teams.
- Enhance cross-functional integration by facilitating communication, alignment, and shared ownership of development goals.
Qualifications:
- Physician Scientist: MD or MD with PhD with a robust scientific background
- 3+ years or more of post-graduate/post-residency experience in industry or academic clinical research.
- Medical residency and/or subspecialty fellowship training highly preferred.
- Strong understanding of early clinical development and translational medicine, mechanisms of disease, and patient care paradigms in relevant therapeutic areas (oncology, immunology and/or metabolic diseases preferred)
- Demonstrated excellence in scientific rigor, operational decision making, risk mitigation, and innovation.
- Proven leadership and effective communication skills, with the ability to collaborate and convey strategic implications to diverse stakeholders.
- Excellent oral, written, and presentation skills for engaging stakeholders and fostering teamwork.
- Strong strategic thinking and critical thinking skills for identifying and addressing bottlenecks while optimizing cross-functional processes.
- Proactive and adaptable in demanding environments, with an operational mindset to improve efficiency and achieve strategic goals.
About Flagship Pioneering:
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.
Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.
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The salary range for this role is $205,000 - $335,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.
