Medical Director, Clinical Development
New
O
Oruka TherapeuticsBiotechnology
Remote OR Hybrid 3 days/week if located near office in Waltham, MA will be required.Full-TimeDirector
Salary$256,000 — $288,000 USD
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Job Details
- Required Skills
- GCP
Requirements
- Medical degree (MD).
- Board certification in a relevant specialty.
- Extensive experience in clinical research and development, ideally within the pharmaceutical industry.
- Strong understanding of clinical trial design.
- Working knowledge of Good Clinical Practice (GCP) guidelines.
- Familiarity with regulatory requirements.
- Excellent communication, leadership, and analytical skills.
Responsibilities
- Support the development of clinical trial protocols including patient selection, endpoints, and data collection.
- Oversee clinical trial conduct at sites to ensure adherence to protocols and Good Clinical Practice (GCP).
- Review and interpret clinical data to assess product safety and efficacy.
- Author clinical documents including protocols, Investigator Brochures, and Clinical Study Reports.
- Provide medical expertise for the therapeutic area and contribute to external regulatory interactions.
- Collaborate with clinical operations, regulatory, biometrics, and pre-clinical teams to optimize development.
- Identify critical development milestones and drive team progress toward timelines.
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