About this opportunity
Clinovo lists this Executive Director, Clinical Development opportunity in san diego, Texas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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. xavwley
Passion for helping build and scale high-performing teams and organizations.
Worksite address
san diego, TX, 78384, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.