Senior Medical Director
Meet Life Sciences
Meet Life Sciences is representing a clinical-stage oncology biotech seeking a Medical Director / Senior Medical Director to support the clinical development of oncology programs. This role will focus on the design, execution, and oversight of clinical trials, including contributing to clinical strategy, serving as primary Medical Monitor, supporting regulatory submissions, and collaborating with cross-functional teams. The position will provide scientific and medical input to ensure the successful conduct of clinical trials and advancement of oncology assets.
This role reports to the VP, Clinical Development, Oncology and is based in our client’s Cambridge, MA office. This role would require a candidate to work on-site 3 times per week.
Key Responsibilities
- Clinical Trial Support: Provide medical expertise to support the lead physician/scientist in the design and execution of oncology clinical trials. Collaborate with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements.
- Medical Monitoring: Serve as Medical Monitor for assigned clinical trials, ensuring patient safety, protocol compliance, and medical oversight. Review safety data, participate in data monitoring activities, and act as the primary medical contact for study teams and investigators.
- Cross-functional Collaboration: Partner with regulatory affairs, clinical operations, pharmacovigilance, biostatistics, medical affairs, and commercial teams to align clinical and business objectives, often across multiple time zones.
- External Representation: Represent our client in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators.
- Data Analysis & Interpretation: Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Collaborate with cross-functional teams to translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement.
- Regulatory Support: Support the preparation of regulatory documents, participate in health authority interactions, and contribute to risk management planning and mitigation strategies throughout the development lifecycle.
- Business Development Support: Support the medical leadership team with licensing opportunities, partnerships, and due diligence activities.
- Scientific Support: Maintain up-to-date knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy and contribute to the clinical development function.
Qualifications
Required
- MD with board certification in Oncology, Hematology-Oncology, or a related specialty.
Preferred
- Clinical development experience, with a focus on late-stage trials, preferably as a Medical Monitor.
- Experience working in cross-functional team environments.
- Strong understanding of oncology drug development, clinical endpoints, and regulatory pathways.
- Clinical practice experience or experience as an investigator.
- Strong communication skills.
- Effective collaboration skills with the ability to interact with internal and external stakeholders.
- High ethical standards and commitment to scientific rigor.
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