Senior Director, Clinical Development

Responsibilities

• Provides clinical science leadership within assigned teams or programs
• Manages the design, planning and execution of clinical trial program(s) as needed with minimal guidance
• Able to play a leadership role in subject matter expertise when interacting with global health authorities
• Leads the study design, implementation and execution of clinical trials on assigned programs
• Prepares clinical study synopses and serves as a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports
• Works cooperatively with project team members to provide clinical development expertise and leadership
• Identifies and cultivates relationships with relevant national and international thought leaders to further project goals
• In partnership with Regulatory Affairs and Project Management, oversees and ensures the quality, coordination and timeliness of clinical sections of IND’s, Investigator Brochures, CTA’s, ISS’s, ISE’s and clinical expert reports, including writing and editing
• Responsible for providing or supervising medical monitoring activities for all human clinical trials including support of adverse event reporting and safety management
• Responsible for ongoing benefit/risk assessment, monitoring adherence to protocols, helping in the investigation of protocol deviations and providing leadership for monitoring activities related to execution of the protocol or program
• Develops relationships with investigators and external organizations and experts to optimize study design and executions
• Provides medical/clinical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents

Requirements

• Doctoral level degree (PhD, MD, PharmD, PsyD) required
• 6+ years of relevant clinical development experience
• Experience in CNS development (Psychiatry or neurology) strongly preferred
• Strong knowledge of the clinical development process
• Solid understanding of the pharmaceutical industry, company competition and commercial side of business
• Experienced in data review and analysis, presentations (internal and external) and regulatory writing (IND, CTD sections)
• Experience building strong relationships within cross-functional groups to achieve results
• Promised ability to identify and solve relevant problems related to clinical development
• Background and proven relevant experience in engaging with clinical trial strategy and trial management
• Understanding of the drug development process including technical, business, and regulatory issues
• IND experience strongly preferred
• Diplomacy and professionalism, ability to build positive relationships both with company leadership and external experts
• Able to command respect from peers and subordinates, capable of highly independent work as well as being a team player and role model
• Excellent interpersonal, verbal and written communication skills
• Proven ability to work remotely and with remote internal and external interdisciplinary teams
• Problem-solving and strategic planning skills
• Excited by innovative ideas in clinical research space
• Self-motivated, resourceful with a 'get the job done' attitude in a fast-paced team environment