Medical Director
$250,000–$400,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Ensure corporate and Medical goals reach milestones within established timelines while delivering within quality and regulatory standards. Execute clinical research activities according to the strategic plan to support product approval, managing internal and external stakeholders. Lead relationships with Clinical Research Organizations and vendors, ensuring quality, patient safety, and GCP compliance. Monitor oncology-based clinical trials to achieve milestones, identify risks, and adjust study protocols. Oversee data management, safety, database review, medical cleaning, and regulatory compliance. Partner with Clinical Operations on study start-up and site initiation visits. Collaborate cross-functionally with Executive Leadership, Clinical leadership, and Heads of Clinical Operations, CMC, and Translational Research. Develop external relationships with KOLs and Study Investigators. Evaluate clinical trial data for efficacy, safety, and key clinical indicators. Resolve study-related issues using scientific expertise and maintain high clinical standards through literature review and conference attendance. This role is on-site in Brighton, MA, with an expectation of 4 days/week in the office.
Required Qualifications
- MD
- experience in oncology
- experience in immune-oncology
- experience in relevant medical specialty area
- 5+ years' life sciences industry experience
- strong oncology medical oversight experience
- Clinical drug development industry experience
- significant knowledge and experience in the execution of clinical trials
- Deep knowledge and expertise in Oncology
- understanding of cross-functional teams
- Thorough understanding of applicable regulatory agency guidelines
- ability to oversee all activities leading to internal cGCP audits
- ability to oversee regulatory inspections related to clinical trial conduct
- Advanced working knowledge of FDA
- Advanced working knowledge of all required regulatory guidelines
- Ability to collaborate in a fast-paced team-oriented environment
- desire to mentor junior leaders and clinical employees
- Proficiency in utilizing Microsoft Office Suite
- other relevant tools
Desired Qualifications
- excellent written and verbal business communication skills
- executive presence
- Self-motivated
- analytical
- meticulous
- flexible
- eager to take on new tasks
- Ability to collaborate in a fast-paced team-oriented environment
- desire to mentor junior leaders and clinical employees
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