Medical Director, Clinical Development - Neuroscience

Role Summary

Medical Director, Clinical Development - Neuroscience oversees the direction, planning, execution, and interpretation of clinical trials or research activities within one or more clinical development programs, contributing to the overall product scientific and business strategy.

Responsibilities

• Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, including education of investigators, study site personnel, and study staff.
• Oversees clinical studies, ensures study integrity, and communicates accumulating data on safety and efficacy; manages enrollment and timelines for key deliverables; assesses and reports serious adverse events per policy and regulations.
• Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents.
• May supervise Associate Medical/Scientific Directors and Clinical Scientists.
• Provides in-house clinical expertise for the molecule and disease, coordinates activities with internal stakeholders, and may participate in due diligence or business development; contributes to translational strategy with Discovery colleagues as needed.
• May chair or serve on Clinical Strategy Team, developing a cross-functionally aligned Clinical Development Plan and supervising matrix team members when applicable.
• Interfaces with opinion leaders related to the molecule and disease area; collaborates with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into Clinical Development Plans and protocols.
• Stays current with professional information and technology to augment therapeutic-area expertise.
• Ensures understanding and compliance with regulatory requirements; serves as a clinical representative in regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards in research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
• At least 2 years of clinical trial experience in pharmaceutical industry, academia, or equivalent.
• Ability to manage a clinical research program of moderate complexity with minimal supervision.
• Ability to lead and collaborate within a cross-functional global team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in clinical strategy development and protocol design.
• Excellent oral and written English communication skills.

Skills

• Clinical trial design and oversight
• Regulatory submissions and interactions
• Cross-functional leadership and collaboration
• Data interpretation and scientific communication
• Translational research and development strategy

Education

• Medical degree (MD/DO) or equivalent; residency completed; subspecialty fellowship desirable.