Executive Director, Clinical Development
BioPhase - San Diego, CA
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Executive Director or Sr. Director, Clinical Development (MD)On-site in San Diego, Remote if outside San DiegoMust have an MDMust have extensive metabolic/endocrinology experience in industryMust have early clin development experience OverviewThe organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. This role will provide medical and strategic direction for programs spanning early clinical research through late-stage development, with particular focus on obesity and related metabolic disorders.The Executive Director will guide the advancement of novel therapeutics by integrating clinical science, regulatory strategy, and operational execution. The successful candidate will have a proven record of leading complex clinical programs, influencing cross-functional teams, and delivering high-quality clinical data in a biotechnology or pharmaceutical environment.Key ResponsibilitiesClinical Strategy & Portfolio LeadershipDefine and oversee clinical development strategy for obesity and metabolic disease programs across all phases of development.Provide senior medical leadership for study design, conduct, and interpretation, including endpoints, patient populations, safety oversight, and benefit-risk evaluation.Serve as the company's internal medical authority for metabolic disease programs and advise executive leadership, project teams, and external partners.Contribute to portfolio prioritization, development sequencing, and long-term clinical planning aligned with corporate objectives.Clinical Program OversightProvide accountability for execution and quality of assigned clinical programs.Oversee development of clinical protocols, amendments, and integrated development plans.Ensure study deliverables are completed within timelines, budget, and quality expectations.Direct medical governance activities and ensure appropriate patient safety oversight across trials.Regulatory & SafetyServe as the senior medical representative in interactions with regulatory agencies for assigned programs.Partner with Regulatory Affairs, Clinical Operations, Biostatistics, CMC, and Program Management to align development and submission strategies.Lead medical contributions to key regulatory documents including INDs, investigator brochures, clinical study reports, and regulatory briefing materials.Participate in regulatory meetings and health authority interactions (e.g., FDA, EMA).Maintain compliance with GCP, ICH guidelines, and applicable regulations.Cross-Functional LeadershipLead collaboration across clinical operations, pharmacovigilance, translational sciences, biostatistics, and commercial teams.Provide mentorship and leadership to clinical staff and contribute to building organizational capabilities in clinical development.External EngagementBuild relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease.Represent the organization at scientific conferences, advisory boards, and investigator meetings.QualificationsMedical degree (MD) required18+ years of clinical development experience within the pharmaceutical or biotechnology industryDemonstrated experience leading clinical studies in obesity or metabolic diseaseSignificant leadership experience, including oversight of teams or programsTrack record of directing clinical programs across multiple development stagesStrong understanding of drug development strategy, clinical operations, and planningExpertise in clinical data analysis and interpretationFamiliarity with SOPs, GCP, ICH guidelines, and regulatory complianceAbility to travel approximately 25%PreferredExperience supporting regulatory submissions and agency interactions (IND, NDA/BLA)Board certification in Endocrinology, Diabetes, Metabolism, or related specialtyExperience within a clinical research or biotech operational environmentExcellent written and verbal communication skills, including presentation of complex data to varied audiencesCore CompetenciesStrategic thinking and program prioritizationStrong cross-functional collaboration and leadershipEffective decision-making and problem solvingOrganizational and communication skillsAbility to manage shifting priorities in a dynamic environmentCompensation & BenefitsFull-time positionCompetitive compensation based on experienceEquity participation and performance bonus eligibilityRetirement plan with employer matchMedical, dental, and vision coverageFlexible spending programsLife insurance and employee assistance programsPaid time off and holidays
Created: 2026-05-10