Executive Director, Clinical Leader– Neuropsychiatry

About the role

The Executive Director, Clinical Leader (CL) is responsible for the development and execution of medical and scientific strategies for late phase compounds (Ph2b/3), and operational implementation, delivered through the effective leadership of a cross-functional Clinical Team (CT).

Responsibilities

• Develops and executes the clinical development plan and owns the design of clinical trials and content of clinical study reports.
• Leads the cross-functional Clinical Team; supervises, develops, and recruits junior medical staff.
• Molecule responsible physician; oversees medical monitoring/reporting and safety activities; evaluates adverse events (pre and post-marketing).
• Interprets, reports, and prepares results of product research for global health authority submissions and external communication.
• Assesses medical publications emerging from the Team and its affiliates.
• Aids Regulatory Affairs in the development of drug/device regulatory strategies and determines requirements for any corrective actions or health authority reporting.
• Acts as a medical contact at the company for global health authorities concerning clinical/medical issues.
• May act as a company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees.
• Assists in evaluating scientific opportunities in the therapeutic area.
• Manages the budget for all project-related clinical activities.

Requirements

• MD (or equivalent) in relevant area with appropriate post-doctoral training and certification.
• Board Certification or Eligibility in Psychiatry or neurology preferred.
• Minimum of 7 years clinical research or pharmaceutical industry experience, inclusive of a minimum of 3 years of Phase II/III development experience within industry.
• Demonstrated ability to develop clinical development plans meeting the highest standards.
• Global registration experience strongly preferred, as is experience working or interacting with Health Authorities.
• Experience working in a Matrix environment is required.
• Effective interface with clinical operations, medical affairs, and marketing.

Qualifications

• Fluent in written and spoken English.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.

Skills

• Collaboration
• Corporate Governance
• Data Management and Informatics
• Developing Others
• Drug Discovery Development
• Global Market
• Health Care Regulation
• Inclusive Leadership
• Industry Analysis
• Innovation
• Leadership
• Market Research
• Research Ethics
• Scientific Evaluation
• Scientific Research
• Stakeholder Management
• Strategic Change