Pioneering Medicines | Cambridge, MA Pioneering Medicines: Medical Director​/Senior Medical Director, Clinical

Pioneering Medicines:
Medical Director / Senior Medical Director, Clinical Development Lead

Cambridge, MA USA

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).

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 New Co 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…