Senior Medical Director, Clinical Development (Oncology)
Location: US Remote
A global, innovation-driven biopharmaceutical company is seeking a Senior Medical Director of Clinical Development to support the advancement of a broad clinical pipeline focused on oncology. With a robust portfolio of approved and late-stage assets, this company is committed to developing high-quality and accessible biologics for patients worldwide.
Position Overview:
Reporting directly to the Chief Medical Officer, the Senior Medical Director will lead clinical development strategy and execution for a portfolio of clinical-stage programs. This individual will oversee medical aspects of clinical trials from design to regulatory submission, providing scientific and operational leadership in close collaboration with cross-functional stakeholders. The role includes responsibility for global trial oversight, medical monitoring, regulatory engagement, and team leadership.
Key Responsibilities
Clinical Development Strategy & Leadership
- Serve as the Clinical Development Lead, providing strategic and operational direction for ongoing clinical trials.
- Line manage a team of 2 Associate Directors and 1 Medica Director
- Lead the design, execution, and oversight of clinical development plans and trial protocols.
- Represent the company in scientific forums, investigator meetings, and global regulatory interactions.
Cross-Functional Collaboration
- Partner closely with Clinical Operations, Regulatory Affairs, Program Management, CMC, and external CROs to ensure alignment across all trial activities.
- Lead and mentor a team of clinical scientists and medical staff to achieve development objectives.
Trial Oversight & Execution
- Ensure medical governance and ethical compliance across all studies, with accountability for clinical deliverables.
- Drive site and investigator engagement, patient recruitment strategies, and data interpretation.
- Oversee the drafting and review of key clinical documents, including protocols, IBs, CSRs, and regulatory submissions.
Regulatory & Safety Responsibilities
- Operate as a central point of contact for medical oversight and safety risk mitigation across studies.
- Ensure adherence to ICH-GCP guidelines and regulatory compliance across all development phases.
- Participate in regulatory authority meetings and contribute to the preparation of submission materials (e.g., INDs, NDAs, etc.).
External Engagement & Representation
- Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and external collaborators.
- Engage in external conferences, advisory boards, and scientific exchange.
Qualifications
Required:
- MD with Board Certification in Oncology (preferred) or strong Oncology background.
- Minimum of 8 years experience in clinical development within the biotech or pharmaceutical industry.
- At least 5 years of line management leadership experience managing clinical or medical affairs teams.
- Demonstrated track record in leading global clinical trials and progressing programs through regulatory milestones.
- Deep understanding of GCP, ICH guidelines, regulatory frameworks (FDA, EMA), and clinical trial operations.
- Strong scientific acumen with the ability to interpret, synthesize, and communicate complex clinical data.
Preferred:
- Experience in thoracic oncology.
- Previous involvement in regulatory submissions and interactions with global health authorities.
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