Senior Medical Director, Clinical Development, Oncology (Remote)
About The Position
The Senior Medical Director, Solid Tumor Oncology, is a senior clinical leader responsible for shaping and executing the medical and clinical strategy for solid tumor programs across the drug development lifecycle. This role provides deep scientific and medical leadership, drives high‑quality evidence generation, partners cross‑functionally to advance pipeline assets, and represents the organization to external stakeholders, including regulatory agencies, investigators, and key opinion leaders. The Senior Medical Director is accountable for ensuring robust clinical development plans, patient‑centric trial designs, and scientifically rigorous decision‑making aligned with the company’s oncology strategy.
Requirements
- MD or MD/PhD required; board certification in Oncology, Hematology‑Oncology, or a related specialty required.
- Advanced clinical training and experience in solid tumor oncology required.
- 10+ years of clinical and/or pharmaceutical industry experience in oncology, with significant solid tumor focus (thoracic oncology experience preferred).
- Demonstrated leadership in global clinical development and late‑phase programs.
- Proven experience with regulatory interactions and contribution to successful filings.
- Track record of strategic leadership across complex, matrixed organizations.
- Strong strategic thinking combined with operational execution skills.
- Excellent communication, influencing, and stakeholder‑management capabilities.
- High ethical standards, sound medical judgment, and strong patient‑centric mindset.
Nice To Haves
- Experience leading registrational or practice‑changing Thoracic oncology studies.
- Familiarity with biomarker‑driven development and precision oncology approaches.
- Comfort operating in fast‑paced, evolving pipeline environments.
Responsibilities
- Provide strategic medical oversight for solid tumor oncology programs from early development through registration and post‑approval.
- Serve as the medical authority for assigned assets, ensuring scientific integrity, patient safety, and regulatory compliance.
- Guide clinical trial design, endpoint selection, biomarker strategy, and translational integration.
- Oversee medical monitoring and contribute to safety governance committees, including SMCs and DMCs as needed.
- Lead the development and execution of integrated clinical development plans aligned with unmet medical needs and competitive landscape.
- Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, and Translational Medicine to drive timely and high‑quality trial delivery.
- Contribute to portfolio strategy, asset prioritization, and lifecycle management decisions.
- Act as a key medical contributor in regulatory interactions with global health authorities (e.g., FDA, EMA).
- Support preparation and review of regulatory documents, including protocols, CSRs, IBs, IND/CTA submissions, and briefing packages.
- Build and maintain strong relationships with investigators, academic collaborators, and external experts.
- Partner with Medical Affairs to ensure seamless transition from development to launch and post‑marketing activities.
- Contribute to publication strategy, abstract development, congress presentations, and scientific exchange.
- Serve as a credible scientific spokesperson for solid tumor programs, internally and externally.
- Provide mentorship and leadership to medical directors and physicians within the oncology organization.
- Foster a culture of scientific excellence, collaboration, accountability, and patient focus.
- Influence cross‑functional teams through thought leadership rather than authority alone.
Benefits
- medical, dental and vision insurance
- 401k retirement savings plan
- flexible paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
