Medical Director, Clinical Development

Role Overview:

The Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
  • Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug.
  • Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).
• Medical Expertise:
  • Provides medical expertise of the therapeutic area, disease state, and potential drug effects.
  • Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team.
  • Stays current with relevant medical literature and clinical trial methodologies.
  • Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle.
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical, and project management teams to optimize the clinical development process.
  • Presents clinical data to internal and external stakeholders.
• Strategic Leadership:
  • Contributes to the overall clinical development strategy.
  • Helps identify critical clinical development milestones and drives the team to meet or exceed timelines.
  • Leads the clinical contribution for clinical study reports, clinical documents, and regulatory submissions.
  • May oversee the work of Clinical Scientists working on the same or other programs.

Qualifications:

• A Medical degree (MD) with board certification in a relevant specialty.
• Extensive experience in clinical research and development, ideally within the pharmaceutical industry.
• A strong understanding of clinical trial design, GCP guidelines, and regulatory requirements.
• Excellent communication, leadership, and analytical skills.