Oruka
Medical Director, Clinical Development
Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States. Posted a month ago
The role
The Medical Director, Clinical Development executes and provides operational oversight for clinical trials. This role supports clinical study design, implementation, and data interpretation to support pipeline products.
What you will do
- Supports development of clinical trial protocols including patient selection, endpoints, and data collection
- Oversees conduct of clinical trials at study sites following protocols and GCP guidelines
- Reviews and interprets clinical data to assess safety and efficacy
- Authors clinical and non-clinical documents like protocols, Investigator Brochures, and Clinical Study Reports
- Provides medical expertise of the therapeutic area, disease state, and potential drug effects
- Analyzes safety concerns and adverse events to make recommendations
- Stays current with medical literature and clinical trial methodologies
- Contributes medical expertise to external interactions with collaborators
- Works cross-functionally with clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management
- Presents clinical data to internal and external stakeholders
Required qualifications
- Medical degree (MD) with board certification in a relevant specialty
- Extensive experience in clinical research and development
- Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
- Excellent communication, leadership, and analytical skills
Nice to have
- Experience within the pharmaceutical industry
Benefits
- Competitive salary and benefits package
- Vibrant startup culture
- Supportive and inclusive team environment
- Opportunities for professional growth and development
About the company
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. The company is advancing a proprietary portfolio of antibodies targeting plaque psoriasis and other dermatologic and inflammatory diseases.