Senior Medical Director, Clinical Development

About the role

Location: Cambridge, Massachusetts. Employment Type: Full-Time.

This individual will serve as a senior study physician supporting the development of novel therapies for patients with solid tumors. The Senior Medical Director will provide medical leadership across global clinical trials, with a strong emphasis on hands-on medical monitoring, patient safety, clinical data review, and cross-functional study execution. The position is well suited to an oncologist with experience leading early- and late-stage clinical studies who wants to remain closely involved in the scientific and medical aspects of clinical development. Experience in lung cancer, including small-cell lung cancer, and antibody-drug conjugates is highly desirable, although candidates with broader solid-tumor expertise will also be considered.

Responsibilities

• Serve as the medical lead and study physician for global oncology clinical trials.
• Provide hands-on medical monitoring, including the review of patient eligibility, safety events, laboratory findings, dose modifications, protocol deviations, and patient-level clinical data.
• Lead the ongoing assessment of emerging safety, efficacy, pharmacokinetic, and pharmacodynamic data.
• Collaborate closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Translational Medicine, and Medical Writing.
• Contribute to clinical development plans, study concepts, protocols, informed consent documents, investigator brochures, clinical study reports, and regulatory submissions.
• Support study design, dose-escalation and expansion strategies, and benefit-risk assessments.
• Provide medical guidance to investigators, study sites, CROs, and internal clinical study teams.
• Lead or participate in safety review committees, data review meetings, investigator meetings, and program-governance discussions.
• Develop productive relationships with investigators, key opinion leaders, cooperative groups, and external scientific experts.
• Support interactions with global health authorities, including the FDA and other regulatory agencies.
• Evaluate clinical data to identify meaningful trends, emerging risks, and opportunities to optimize development strategy.
• Contribute to publications, abstracts, scientific presentations, and the communication of clinical study results.
• Provide scientific and medical input into potential indications, combination strategies, and lifecycle-development opportunities.
• Mentor clinical scientists and other members of the clinical development organization.

Qualifications

• MD or equivalent medical degree required.
• Board certification or board eligibility in Medical Oncology, Hematology/Oncology, or a related specialty strongly preferred.
• Approximately five or more years of clinical development experience within a biotechnology, pharmaceutical, or related research organization.
• Demonstrated experience serving as a study physician or medical monitor for interventional oncology clinical trials.
• Strong knowledge of solid-tumor drug development and contemporary oncology clinical practice.
• Experience reviewing patient-level safety and efficacy data and making timely medical decisions.
• Experience contributing to clinical protocols, development plans, regulatory documents, and health-authority interactions.
• Ability to operate effectively across global, multidisciplinary clinical development teams.
• Strong written, verbal, presentation, and relationship-management skills.
• Sound clinical judgment and the ability to succeed in a fast-paced, data-driven environment.

Required Skills

• Demonstrated experience serving as a study physician or medical monitor for interventional oncology clinical trials.
• Strong knowledge of solid-tumor drug development and contemporary oncology clinical practice.
• Experience reviewing patient-level safety and efficacy data and making timely medical decisions.
• Experience contributing to clinical protocols, development plans, regulatory documents, and health-authority interactions.
• Ability to operate effectively across global, multidisciplinary clinical development teams.
• Strong written, verbal, presentation, and relationship-management skills.
• Sound clinical judgment and the ability to succeed in a fast-paced, data-driven environment.

Preferred Skills

• Clinical or drug-development experience in lung cancer, particularly small-cell lung cancer.
• Experience developing antibody-drug conjugates or other targeted oncology therapies.
• Experience within global Ph3 studies.
• Familiarity with global clinical programs conducted across the United States, Europe, and Asia.
• Experience supporting regulatory submissions or major clinical-development milestones.