Director/Senior Medical Director, Clinical Development
New
O
Oruka TherapeuticsPharmaceutical
Remote; Waltham, Massachusetts, United StatesFull-TimeDirector
Salary255,000 - 343,000 USD per year
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Job Details
- Required Skills
- Project ManagementGCP
Requirements
- Medical degree (MD)
- board certification in a relevant specialty
- Extensive experience in clinical research and development
- Strong understanding of clinical trial design
- GCP guidelines
- regulatory requirements
- Excellent communication skills
- leadership skills
- 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
- 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
- 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
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