Biophase Jobs in Usa

Executive Director, Clinical Development (MD)

On-site in San Diego

Must have an MD

Overview

The 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 Responsibilities

Clinical Strategy & Portfolio Leadership

• Define 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 Oversight

• Provide 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 & Safety

• Serve 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 Leadership

• Lead 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 Engagement

• Build relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease.
• Represent the organization at scientific conferences, advisory boards, and investigator meetings.

Qualifications

• Medical degree (MD) required
• 10+ years of clinical development experience within the pharmaceutical or biotechnology industry
• Demonstrated experience leading clinical studies in obesity or metabolic disease
• Significant leadership experience, including oversight of teams or programs
• Track record of directing clinical programs across multiple development stages
• Strong understanding of drug development strategy, clinical operations, and planning
• Expertise in clinical data analysis and interpretation
• Familiarity with SOPs, GCP, ICH guidelines, and regulatory compliance
• Ability to travel approximately 25%

Preferred

• Experience supporting regulatory submissions and agency interactions (IND, NDA/BLA)
• Board certification in Endocrinology, Diabetes, Metabolism, or related specialty
• Experience within a clinical research or biotech operational environment
• Excellent written and verbal communication skills, including presentation of complex data to varied audiences

Core Competencies

• Strategic thinking and program prioritization
• Strong cross-functional collaboration and leadership
• Effective decision-making and problem solving
• Organizational and communication skills
• Ability to manage shifting priorities in a dynamic environment

Compensation & Benefits

• Full-time position
• Competitive compensation based on experience
• Equity participation and performance bonus eligibility
• Retirement plan with employer match
• Medical, dental, and vision coverage
• Flexible spending programs
• Life insurance and employee assistance programs
• Paid time off and holidays