Executive Director, Clinical Development

Position Summary

The Executive Director, Clinical Development will provide strategic and medical leadership for a late-stage clinical development program targeting a rare disease indication. This physician leader will be responsible for shaping development strategy, guiding cross-functional execution, and ensuring alignment with regulatory expectations as the program progresses toward major development milestones.

The ideal candidate brings a combination of scientific rigor, clinical insight, operational understanding, and proven experience leading late-stage or registration-enabling studies within a biotechnology or pharmaceutical environment.

Key Responsibilities

• Lead the overall clinical development strategy for a high-priority therapeutic program.
• Translate clinical, scientific, and translational data into actionable development plans and key decision points.
• Drive strategic discussions regarding development pathways, risk-benefit assessments, and lifecycle planning.
• Oversee the design and execution of pivotal and registration-directed clinical studies.
• Provide medical and scientific leadership across all stages of clinical development.
• Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and other functional teams to ensure successful study execution.
• Monitor emerging clinical data and safety information, providing recommendations to support sound development decisions.
• Contribute to protocol development, study design, endpoint strategy, and patient population selection.
• Support interactions with regulatory agencies and contribute to health authority meeting preparations.
• Guide development activities to ensure inspection readiness, data quality, and adherence to regulatory standards.
• Build strong relationships with clinical investigators, key opinion leaders, and external advisors.
• Serve as a key member of the development leadership team and help shape broader portfolio strategy.

Qualifications

• MD or equivalent medical degree.
• Significant clinical development experience within biotechnology and/or pharmaceutical organizations.
• Demonstrated success leading Phase II, Phase III, and/or registration-enabling clinical programs.
• Experience contributing to global regulatory submissions and agency interactions.
• Track record of advancing programs through major clinical and regulatory milestones.
• Strong understanding of global drug development, clinical trial design, and regulatory strategy.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Ability to thrive in a fast-paced, evolving biotech environment.
• Strong clinical judgment and commitment to patient safety and scientific excellence.
• Passion for helping build and scale high-performing teams and organizations.