Medical Director
Summit Therapeutics, Inc.
full-time
Posted on:
Location Type: Office
Location: Palo Alto • California • Florida • United States
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Salary
💰 $237,000 - $250,000 per year
Job Level
About the role
- Oversee global Phase 3 clinical trials and BLA (Biologic Licensing Application) filings
- Develop and execute integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies
- Obtain scientific advisory input and work with biostatisticians for phase 3 design and analyses
- Support regulatory interactions for product advancement
- Provide medical insight across a myriad of functions from discovery to manufacturing
- Lead investigator engagements and participate in face-to-face interaction and protocol training
- Manage teams to execute on clinical development goals
- Participate in medical review of adverse event reports and safety data monitoring
- Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and other agencies
- Presentations to external stakeholders including regulators and scientific conference attendees.
Requirements
- MD with hematology/oncology product development and experience across stages of clinical development
- Board certified or eligible MD preferred
- Significant oncology experience is required
- Minimum of 3+ years experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
- Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
- Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission.
Benefits
- Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location.
- Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial designmedical oversightbiostatisticsregulatory interactionsadverse event reportingsafety data monitoringprotocol trainingclinical developmentdata analysisoncology therapeutics
Soft Skills
leadershipcollaborationentrepreneurial mindsetinitiativecommunicationteam managementproblem-solvingadaptabilitypresentation skillsinterpersonal skills
Certifications
MDboard certification in hematology/oncology