Executive Medical Director, Clinical Development

Job Summary:

The Executive Medical Director, Clinical Development is a senior physician-scientist leader responsible for providing medical and scientific direction across one or more of the organization's clinical development programs. Reporting to the Chief Medical Officer, this individual serves as the medical lead for assigned pipeline assets — owning the clinical strategy, protocol design, and medical oversight of clinical trials from early-phase through late-stage development. The Executive Medical Director is a key organizational voice in regulatory interactions, clinical investigator engagements, and cross-functional program team leadership, and plays a central role in advancing the organization's pipeline toward regulatory submission and approval. This role combines deep clinical and scientific expertise with the strategic and operational leadership required to drive programs forward in a fast-paced, growth-stage biopharmaceutical environment.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Serve as the physician medical lead for assigned clinical development programs — owning the clinical strategy, development plan, and medical decision-making for pipeline assets across all relevant phases of development (Phase I through Phase III/IV).
• Lead the design, development, and review of clinical trial protocols, informed consent documents, investigator brochures, and clinical sections of regulatory submissions (IND, NDA/BLA, global filings) — ensuring scientific rigor, patient safety, and regulatory alignment.
• Provide medical oversight of ongoing clinical trials — including safety monitoring, medical monitoring activities, serious adverse event (SAE) review, protocol deviation assessment, and benefit-risk evaluation — in close partnership with clinical operations, pharmacovigilance, and biostatistics.
• Lead and actively contribute to regulatory agency interactions — including FDA and EMA meetings, briefing document preparation, and responses to health authority questions — serving as a primary medical spokesperson for assigned programs.
• Drive cross-functional clinical program teams as the medical lead — providing strategic direction and scientific guidance to clinical operations, regulatory affairs, translational medicine, biostatistics, and medical affairs to ensure integrated, high-quality program execution.
• Contribute to the development of the organization's clinical and medical strategy by providing thought leadership on therapeutic area trends, competitive landscape analysis, emerging clinical data, and evolving regulatory expectations relevant to the pipeline.
• Support the preparation and review of scientific publications, congress presentations, and medical education materials that advance the organization's scientific reputation and program visibility.
• Contribute to business development and in-licensing evaluations by providing clinical and medical assessment of external assets and partnership opportunities.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Medical degree (MD or DO) required. Board certification in a relevant clinical specialty strongly preferred. Completion of clinical fellowship training in a relevant therapeutic area preferred
• 5–7 years in a clinical development role within the life sciences industry.
• Demonstrated experience as a physician medical lead on clinical programs across multiple phases of development, including experience with regulatory submissions and agency interactions.
• Deep expertise in clinical trial design, protocol development, GCP compliance, and the medical and scientific interpretation of clinical trial data across Phase I–III/IV development.
• Comprehensive knowledge of global regulatory frameworks (FDA, EMA, ICH guidelines) with hands-on experience contributing to regulatory submissions, briefing documents, and health authority meeting preparation.
• Proficiency in clinical safety monitoring, SAE assessment, medical monitoring practices, and pharmacovigilance processes applicable to clinical-stage drug development programs.
• Strong working knowledge of biostatistics principles, clinical endpoints, adaptive trial design concepts, and translational biomarker strategies as they apply to clinical program design and execution.
• Proven clinical development leader with the ability to serve as the medical authority on cross-functional program teams — setting scientific direction, resolving complex medical questions, and driving alignment across diverse functional stakeholders.
• Strong track record of leading clinical programs through critical milestones — including first-in-human studies, proof-of-concept data readouts, pivotal trial initiation, and regulatory submissions — with a bias for rigor, speed, and quality.
• Collaborative and influential leader who builds trust and credibility with clinical investigators, KOLs, and regulatory agencies — leveraging scientific expertise and interpersonal effectiveness to advance the organization's programs and reputation.
• Committed mentor and scientific role model, dedicated to developing the next generation of clinical development talent within the organization and fostering a culture of scientific excellence and continuous learning.
• Exceptional scientific and medical communication skills — able to present complex clinical data, safety findings, and development strategies clearly and compellingly to diverse audiences including regulators, investigators, executives, investors, and patient communities.
• Skilled in authoring and reviewing high-quality clinical documents including protocols, investigator brochures, clinical study reports, regulatory briefing documents, and scientific manuscripts.
• Strong cross-functional communicator with the ability to translate medical and scientific complexity into actionable direction for clinical operations, regulatory, biostatistics, and commercial teams.