Note: The job is a remote job and is open to candidates in USA. Kaye/Bassman International is partnering with a well-funded, clinical-stage biotechnology company advancing innovative therapies in areas of high unmet medical need. They are seeking a Senior Director of Clinical Development to lead clinical development activities, provide medical leadership for clinical trials, and collaborate with various teams to shape clinical strategy and ensure trial execution.

Responsibilities

• Lead clinical development activities across one or more global development programs
• Provide medical leadership for Phase I–III clinical trials, including study design, execution, data review, and interpretation
• Serve as the medical monitor and clinical lead across active studies
• Review safety narratives, adverse events, protocol deviations, coding, MedDRA / WHO Drug terms, and patient-level clinical data
• Partner closely with Clinical Operations, Regulatory, Biometrics, Safety / PV, Medical Writing, and external vendors
• Contribute to protocols, investigator brochures, clinical study reports, regulatory documents, and study-level materials
• Support regulatory strategy and interactions with global health authorities
• Engage with investigators, KOLs, advisory boards, and clinical trial sites
• Help evaluate emerging clinical data, competitive intelligence, and development opportunities

Skills

• M.D., D.O., or equivalent medical degree
• Strong clinical background, ideally with residency, fellowship, or meaningful hospital-based clinical training
• Medical training or clinical practice experience in the U.S., Canada, U.K., Western Europe, Australia, or another comparable Western clinical training environment strongly preferred
• Industry clinical development experience within biotechnology or pharmaceutical companies
• Hands-on experience supporting or leading Phase II and / or Phase III clinical trials
• Experience with medical monitoring, safety review, medical narratives, clinical data review, coding review, and protocol deviation review
• Ability to work cross-functionally in a fast-paced, execution-focused biotech environment
• Hematology, coagulation, transfusion medicine, anesthesiology, critical care, trauma, surgery, perioperative medicine, cardiovascular medicine, or related acute care background
• Experience with therapies impacting bleeding, clotting, acute physiologic response, or hospital-based interventions
• Experience with biologics, cellular therapies, complex biologic products, or advanced therapeutic modalities
• Prior experience in small to mid-sized biotech environments
• Exposure to late-stage, registrational, or global development programs

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