Medical Director, Clinical Development

Key Responsibilities

• 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)
• 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
• Presents clinical data to internal and external stakeholders
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process
• Contributes to the overall clinical development strategy
• Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding 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

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

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients
• Competitive salary and benefits package
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work
• Opportunities for professional growth and development