Director/Senior Medical Director, Clinical Development

Oruka Therapeutics • Waltham, MA

18h • Hybrid

About The Position

The Medical/Senior 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

• 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 help ensure optimization of the clinical development process
• Presents clinical data to internal and external stakeholders
• Strategic Leadership:
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree