Senior Medical Director, Clinical Development, Oncology (Remote)

Key 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.
• Lead the development of robust clinical development plans, patient-centric trial designs, and scientifically rigorous decision-making aligned with the company’s oncology strategy.

Qualifications

• 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.
• Experience: 10+ years of clinical and/or pharmaceutical industry experience in oncology, with significant solid tumor focus (thoracic oncology experience preferred).
• Leadership: Demonstrated leadership in global clinical development and late-phase programs.
• Experience: Proven experience with regulatory interactions and contribution to successful filings.
• Track record: Track record of strategic leadership across complex, matrixed organizations.
• Skills & Competencies: 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.