Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development responsible for scientific and strategic leadership across late-stage clinical programs, including anticipated regulatory interactions. Leads projects under the Head of Clinical Development, collaborates with business development, and fosters innovation and external partnerships. Requires a doctoral degree and a track record of success in clinical development.

Responsibilities

• Supervises one or more direct reports and leads the clinical development team for a product
• Leads the design and execution of projects conducted in support of clinical research programs
• Leads the clinical study team in protocol development, monitoring, study reports, training documents, and other clinical/regulatory documents
• Leads the clinical development product team to facilitate goals and study quality metrics
• Contributes to investigator and advisory board meeting organization, preparation, and execution
• Ability to work across multiple projects and teams
• Maintains up-to-date knowledge of regulations and guidelines for the therapeutic area and advances in the field
• Cultivates relationships with external partners (investigators, clinicians, scientists) to support innovation and business development
• Assists with due diligence for business development opportunities
• May require travel to field sites, meetings, and conferences

Qualifications

• Doctorate degree: MD, Ph.D., or PharmD
• At least 15 years of clinical/research experience, including 5 years of industry experience
• Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Ability to make independent, timely, and appropriate decisions
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Excellent written and verbal communication skills
• Intellectual curiosity, flexibility, and persistence
• High level of organizational and project management skills
• Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators

Education

• Doctorate degree: MD, Ph.D. or PharmD in a related area

Additional Requirements

• May require travel to field sites, internal and external meetings and conferences