Director, Clinical Development

About This Role

The Director of Clinical Development is a motivated and experienced Clinical Scientist with expertise in Phase 1-3 clinical studies. This individual will provide scientific input during protocol development, study design, oversight of study conduct, and interpretation of study results.

Responsibilities

• Lead the preparation of clinical study related documents including protocols, charters, meeting presentations, publications, and clinical sections of regulatory documents.
• Support the design and execution of key elements of the Clinical Development Plan within a therapeutic area.
• Lead or support the clinical sub team and participate in the program team.
• Contributes to preparation of all ancillary study documents including informed consent forms, case report forms, operations manuals, diaries, investigator’s brochures, and operations manuals.
• Assist with the preparation, or oversite of vendor preparation, of data listings, clinical study reports and clinical submission documents.
• Collaborate with clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation.
• Collaborate with clinical operations team to review vendor, CRO and site scope of work, study budget, and plans or manuals related to study data, IVRS, central labs, etc.
• Provide scientific expertise for selection of investigators and vendors.
• Develop internal and external training materials and presentations.
• Train colleagues, CRO staff, and study site staff on the clinical protocol

Requirements

• 10+ years of demonstrated drug development or medical research experience within the biopharmaceutical industry
• Experience leading all stages of clinical trials
• Knowledge of first-in-human clinical trial design
• Experienced supporting clinical trial design, statistics, and data review tools
• Proficiency in development of protocols, case report forms, informed consent documents, and study initiation and monitoring activities
• Proven ability to share scientific data effectively across functions and through presentations
• Experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends

Qualifications

• Relevant clinical or biomedical Ph.D. or MSc degree
• 10+ years of demonstrated drug development or medical research experience within the biopharmaceutical industry.

Nice to Have

• Metabolic experience highly preferred
• Gene therapy experience in a biotech company preferred

Benefits