Sr. Medical Director - VP of Clinical Development
Sr. Medical Director - VP of Clinical Development
Watertown, MA - On-site (Hybrid may be considered)
Compensation: $330,000-420,000 + bonus + equity
Company Summary:
Join a well‑capitalized, publicly traded precision‑oncology company that is redefining how cancer therapeutics are developed. The organization is built around a functional biology platform that moves beyond genomics to directly measure drug‑regulated pathway activity in tumors. Scientific, translational, and clinical strategy are deeply integrated, with biomarkers serving as a core design principle rather than an add‑on. The company is led by seasoned physician‑scientists with a track record of advancing therapies through late‑stage development and regulatory approval. Backed by top‑tier investors, it maintains a multi‑year operating runway while still operating at a size where individual contributions meaningfully shape programs and strategy. This is an opportunity for someone who thrives in intellectually engaged, high‑ownership settings, values scientific depth, and wants to work on programs with real clinical consequence, without the bureaucracy of larger organizations.
Responsibilities:
- Provide overall clinical development leadership and strategic direction across one or more oncology programs, with full accountability from IND through late‑stage development and registration.
- Partner closely with the CEO, CMO, and senior leadership to shape portfolio strategy, development priorities, and long‑range clinical plans aligned with corporate objectives.
- Lead the design, execution, and interpretation of global clinical trials, ensuring scientific rigor, operational feasibility, and regulatory credibility.
- Serve as the primary clinical authority for program decision‑making, including dose selection, indication expansion, go/no‑go decisions, and investment prioritization.
- Oversee safety strategy and risk‑benefit assessment across programs, including medical monitoring oversight and escalation of key safety signals.
- Guide translational and biomarker strategy in close collaboration with translational medicine, ensuring mechanistic hypotheses are embedded in clinical development plans.
- Represent clinical development at internal governance forums and external venues, including Board discussions, investor updates, DSMBs, and key scientific meetings.
- Lead regulatory interactions alongside Regulatory Affairs, including IND meetings, end‑of‑Phase discussions, and interactions supporting NDA strategy.
- Ensure high‑quality clinical deliverables, including protocols, SAPs, clinical study reports, investigator brochures, and regulatory submission content.
- Build, mentor, and retain a high‑performing clinical development team, fostering a culture of scientific excellence, accountability, and cross‑functional collaboration.
- Partner with Clinical Operations, Biostatistics, Data Management, and CROs to ensure trials are delivered on time, within budget, and to GCP standards.
- Act as a senior cross‑functional leader, driving alignment across research, biomarker, regulatory, and commercial stakeholders.
Qualifications:
- MD or Foreign Equivalent
- 3 years + biotech/Pharma experience working on Oncology studies
- US Board Certification and 2+ years practicing as an oncologist prior to industry.