BCBA delivering clinical - behavioral assessments and support plans for adults with disabilities at Vinfen. Collaborating with multidisciplinary teams to enhance clients' quality of life.
About the role
- Medical Director overseeing global Phase 3 oncology clinical trials and BLA filings at Summit Therapeutics. Responsible for clinical trial program development, regulatory support, and team leadership.
Responsibilities
- Oversee global Phase 3 clinical trials and BLA 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
- Work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence
- Play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training
- Provide medical insight across a myriad of functions from discovery to manufacturing as needed
- Make vital contributions on pivotal programs in clinical development program
- Direct human clinical trials, phases 1-3, for lead candidate in development
- Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance
- Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
- Presentations to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders.
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
- Bonuses
- Stock options
- Comprehensive health benefits
- Retirement plans
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