Executive Medical Director

Responsibilities and Duties

• Serve as the Clinical / Medical Lead across multiple complex clinical studies and development programs, ensuring high-quality trial execution, patient safety, and scientific integrity.
• Act as a senior clinical development resource within the organization, providing scientific and operational guidance to fellow Medical Directors and study teams.
• Lead the creation, optimization, and execution of comprehensive Clinical Development Plans (CDPs) and innovative study protocols for new indications, lifecycle management activities, and future pipeline opportunities.
• Provide strategic medical and scientific leadership across cross-functional matrix teams, including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Translational Research, and Drug Safety / Pharmacovigilance.
• Provide physician oversight for medical monitoring activities, including subject eligibility evaluation, protocol deviations, endpoint assessment, and emerging clinical issues.
• Provide clinical safety leadership across assigned programs, including review of aggregate safety data, SAE evaluation, Benefit-Risk evaluation, and collaboration with Pharmacovigilance to support patient safety.
• Lead the clinical authoring, review, and defense of key regulatory documents (including INDs, Briefing Packages, Investigator’s Brochures [IBs], Clinical Study Reports [CSRs], and NDA/BLA/MAA clinical modules) and serve as a primary clinical representative in meetings with the FDA, EMA, and other global health authorities.
• Direct interpretation, synthesis, and reporting of complex clinical data from ongoing and completed trials, contributing to high-impact peer-reviewed publications, congress presentations, and internal executive briefings.
• Establish and maintain collaborative partnerships with external Key Opinion Leaders (KOLs), investigators, academic collaborators, and study sites; support and participate in Scientific Advisory Boards and Data Safety Monitoring Boards (DSMBs).
• Mentor, guide, and support Medical Directors and cross-functional study team members, sharing clinical development expertise and serving as a resource for protocol design, medical monitoring, regulatory strategy, and study execution.

Qualifications and Skills

• Doctor of Medicine (MD) or equivalent international medical degree required; Board Certification in Endocrinology, Pediatrics, Genetics, Internal Medicine, or a related specialty preferred.
• Minimum of 8-10 years of clinical development experience within the pharmaceutical or biotechnology industry, including experience leading global clinical development programs and regulatory interactions; Experience in rare disease, endocrinology, obesity, metabolic disease, pediatrics, or related therapeutic areas strongly preferred.
• Demonstrated success serving as a senior medical leader within a Clinical Development organization, including mentoring and developing other physicians and providing technical leadership across multiple studies or programs.
• Demonstrated track record of successful clinical trial design, medical oversight, and execution across Phase 1 through Phase 3 clinical studies, including registrational/pivotal trials.
• Proven experience leading clinical components of global regulatory filings (IND/NDA/BLA/MAA) and direct participation in formal interactions with regulatory agencies (e.g., FDA, EMA, PMDA).
• Deep expertise in GCP/ICH guidelines, pharmacovigilance reporting standards, ethical conduct of clinical trials, and global clinical regulatory policies.
• Exceptional leadership and matrix collaboration capabilities, with demonstrated success influencing cross-functional teams and external stakeholders and serving as a trusted subject matter expert and mentor within a Clinical Development organization.
• Demonstrated ability to balance scientific rigor, patient needs, regulatory requirements, and business priorities within a fast-paced biotech environment.
• Superior written, verbal, and presentation communication skills, with the ability to convey complex medical/scientific concepts clearly to diverse internal and external audiences.
• Ability to travel domestically and internationally as necessary (up to 20%).