Senior Director, Clinical Development

Responsibilities

• Provide clinical science leadership within assigned teams or programs
• Manage the design, planning, and execution of clinical trial programs
• Lead study design, implementation, and execution of clinical trials
• Prepare clinical study synopses and contribute to protocol writing and major amendments
• Identify and cultivate relationships with national and international thought leaders
• Oversee the quality and timeliness of clinical sections of INDs, Investigator Brochures, and CTAs
• Provide or supervise medical monitoring activities, including safety management and adverse event reporting
• Conduct ongoing benefit/risk assessments and monitor protocol adherence

Requirements

• Doctoral level degree (PhD, MD, PharmD, or PsyD)
• 6+ years of relevant clinical development experience
• Experience in small molecule development
• Experience in data review, ana...