Senior Director, Clinical Development

SUMMARY 

The Senior Director, Clinical Development will lead the clinical strategy and study execution of our I&I development programs. Working closely with internal and external stakeholders, this individual will drive clinical development plans, provide medical leadership across clinical studies, and contribute to study design, protocol development, safety reviews, data interpretation, regulatory submissions, publications, and presentations. As a key member of the development leadership team, this individual will guide cross-functional activities to achieve program objectives while ensuring compliance with ICH-GCP and applicable regulatory requirements.

 RESPONSIBILITIES:

Clinical Strategy & Leadership

• Develop and execute a multi-year clinical development strategy for our clinical programs.
• Lead creation and execution of medical plans across the US, Europe, and other potential jurisdictions.
• Provide medical leadership and scientific guidance to a cross-functional program team through all phases of clinical development.
• Evaluate and integrate emerging scientific, clinical, and competitive insights into development strategies.

Clinical Trial Design & Execution

• Drive the development of clinical content including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports
• Lead Medical Monitoring, or provide oversight and guidance to designated Medical Monitors, across clinical programs; provide medical oversight, review safety data, and ensure adherence to protocol and regulatory standards.
• Partner with clinical operations to support site selection, investigator training, and issue resolution during study conduct.

Safety & Compliance

• Oversee the assessment and interpretation of safety data, including adverse events, safety signals, and risk mitigation strategies.
• Oversee pharmacovigilance to ensure timely evaluation and reporting of safety information.
• Ensure clinical programs follow ICH-GCP, ethical standards, and regional/global regulatory requirements.

Regulatory & Scientific Communication

• Contribute to the preparation and review of regulatory submissions including INDs, CTAs, briefing documents, and NDAs/BLAs.
• Represent the clinical program in interactions with health authorities such as FDA, EMA, and other global agencies.
• Develop and review key clinical documents including protocols, investigator brochures (IBs), clinical study reports (CSRs), and publications.

Cross-Functional Collaboration

• Partner cross-functionally with Research and Operations functions
• Provide medical and scientific expertise for internal decision-making, including business development activities as required
• Support advisory boards, KOL engagement, and scientific congress activities.

External Engagement

• Build and maintain relationships with investigators, key opinion leaders, and external experts.
• Stay current on scientific advances, competitive intelligence, and therapeutic area trends to inform program direction.

EXPERIENCE & QUALIFICATIONS 

• M.D. required; significant I&I or rare disease clinical development experience strongly preferred
• Minimum of 8+ years of relevant experience with a demonstrated track record of success in clinical research and drug development within academia, biotechnology, and/or the pharmaceutical industry.
• Demonstrated experience designing and executing clinical programs across multiple phases and geographic regions.
• Experience with phase 1/2 clinical studies is required
• Strong knowledge of GCP, ICH guidelines, global regulatory requirements, and the drug development process.
• Experience building and leading a team of direct reports and contractors
• Proven medical and scientific leadership of cross-functional teams, with experience engaging regulatory agencies, investigators, KOLs, and external partners.
• Excellent analytical, strategic, and communication skills.
• Experience authoring and reviewing key clinical and regulatory documents and contributing to global regulatory submissions and health authority interactions.