Medical Director

Company: Biotech

Position Overview:

The Medical Director will play a critical role in guiding clinical development programs, providing scientific insights, and serving as a medical expert both internally and externally. This role requires strong collaboration with cross-functional teams, including clinical operations, regulatory affairs, and research & development.

Key Responsibilities:

• Clinical Development Strategy: Lead the development and execution of clinical strategies for oncology programs, from preclinical through late-stage development, including trial design and protocol development.
• Medical Expertise: Serve as the primary medical expert on oncology, providing scientific and clinical insights for drug development and ensuring clinical trials are aligned with corporate goals and regulatory standards.
• Study Oversight: Oversee the conduct of clinical trials, monitor safety data, ensure protocol compliance, and address any medical concerns that arise during the study.
• Regulatory Support: Collaborate with regulatory affairs to provide medical input on regulatory submissions, including INDs, NDAs, and briefing packages for global regulatory agencies such as the FDA, EMA, etc.
• Cross-Functional Collaboration: Partner with internal teams (R&D, commercial, clinical operations) to ensure scientific and medical integrity of development programs. Act as a liaison between the clinical development team and external key opinion leaders (KOLs), investigators, and regulatory bodies.
• Scientific Leadership: Represent the company at scientific and medical meetings, conferences, and advisory boards. Present clinical data to KOLs, stakeholders, and regulatory bodies.
• Medical Communication: Provide clinical input on publications, presentations, and investor communications. Ensure the medical accuracy of external and internal documents related to oncology programs.
• Patient Safety: Ensure patient safety by monitoring adverse event data and developing risk management plans in accordance with global regulatory guidelines.
• Team Leadership: Manage, mentor, and develop clinical teams, including physicians, scientists, and clinical operations staff.

Qualifications:

• Medical Degree: MD or equivalent with board certification in Oncology, Hematology/Oncology, or related fields.
• Experience: Minimum of 5-7 years of experience in oncology clinical development within biotech, pharma, or academic settings.
• Leadership: Proven ability to lead cross-functional teams and manage complex oncology clinical programs.
• Regulatory Knowledge: In-depth understanding of the regulatory environment for oncology drug development, including experience with IND, NDA, or BLA submissions.
• Communication: Excellent verbal and written communication skills, with the ability to convey complex medical and scientific information to diverse audiences.
• Clinical Trial Expertise: Experience designing, implementing, and monitoring Phase I-IV clinical trials in oncology.
• Collaboration Skills: Demonstrated ability to work collaboratively in a fast-paced, entrepreneurial environment.

Preferred Qualifications:

• Experience in immuno-oncology, targeted therapies, or cell and gene therapies.
• Strong network within the oncology KOL community.
• Experience with global clinical trial management.

What We Offer:

• Competitive salary and equity compensation
• Comprehensive health and wellness benefits
• Professional development and career growth opportunities
• A dynamic, collaborative work environment in Boston’s biotech hub

If you are a driven, innovative medical leader with a passion for oncology, we encourage you to apply and join our mission to transform cancer treatment for patients around the world.

How to Apply:

Please submit your CV and cover letter to Alex.