Medical Director, Clinical Development

Oruka Therapeutics•Waltham, MA

9h•$256,000 - $288,000•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases, aiming to provide patients with significant relief and high rates of disease clearance. The company is seeking a Medical Director of Clinical Development to play a key role in the execution and operational oversight of clinical trials. This role involves supporting clinical study design, implementation, and data interpretation, ensuring high-quality data generation for pipeline products. The Medical Director will collaborate cross-functionally to align clinical activities with development plans and ensure trials meet 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 (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.
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.
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.