Senior Vice President, Medical Director

Senior Vice President, Medical Director

Direct Hire Full-Time Role

Salary Range: $355,000 - $375,000 per year

Location: Palo Alto, CA - Hybrid Role

Job Summary:

Reporting to the President, this pivotal role will be instrumental in shaping and executing the clinical strategy, from early-stage development through registration and post-marketing activities.

Duties and Responsibilities:

• Clinical Program Leadership: Design, implement, and medically monitor clinical trials (Phase 1-3) for oncology assets. This includes protocol development, CRO oversight, site selection, and medical monitoring.
• Strategy and Development: Contribute to the overall clinical development plan and strategy for oncology programs, ensuring alignment with regulatory requirements and commercial objectives.
• Data Analysis and Interpretation: Lead the medical review, analysis, and interpretation of clinical trial data, including safety, efficacy, and pharmacokinetic data.
• Regulatory Submissions: Prepare and contribute to regulatory documents (e.g., INDs, NDAs, briefing book etc.), abstracts, presentations, and manuscripts. Represent the company in interactions with regulatory authorities.
• Cross-functional Collaboration: Work closely with research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, and commercial teams to ensure seamless program execution.
• External Engagement: Establish and maintain strong relationships with key opinion leaders (KOLs), investigators, and patient advocacy groups. Present clinical data at scientific conferences and advisory boards.
• Safety Monitoring: Oversee ongoing safety monitoring of clinical trials, including review of adverse events, serious adverse events, and development of risk management plans together with safety team.
• Team Mentorship: Mentor and provide medical oversight to junior clinical development team members.
• Due Diligence: Participate in due diligence activities for partnering opportunities as needed.

Requirements and Qualifications:

• MD required, with board certification preferred but not required.
• Solid tumor oncology experience preferred.
• Minimum of 10+ years of clinical drug development experience in the biotechnology or pharmaceutical industry, with a focus on oncology biologics.
• Demonstrated success in leading and managing clinical trials from early to late-stage development.
• Strong understanding of clinical trial design, biostatistics, medical monitoring, and regulatory requirements (FDA, EMA, ICH guidelines).
• In-depth knowledge of current oncology treatment landscapes, emerging therapies, and unmet medical needs.
• Experience with regulatory submissions (INDs, NDAs, BLAs) preferred.
• Excellent communication, presentation, and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
• Proven ability to work independently and as part of a team in a fast-paced, dynamic environment.
• Ability to travel as required (approximately 10-15%).

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.