Senior Medical Director, Clinical Development

Oruka Therapeutics • Waltham, MA

100d • $205,000 - $260,000

About The Position

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 our 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.

Requirements

• 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

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
• 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
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams
• Presents clinical data to internal and external stakeholders
• 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

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees