About Pioneering Medicines:

Pioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship’s innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship’s bioplatform companies. Within Flagship’s Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners’ R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.

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. 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 completion required
• Subspecialty fellowship training is 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.

Location: Cambridge, MA

About Flagship Pioneering:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

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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