Clinical Director developing and implementing strategies for Admitting Physician Program and Inpatient Management. Ensuring compliance, metrics evaluation, and overseeing clinical guidelines with various healthcare agencies.
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
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Clinical Director overseeing RMBHS clinical services, ensuring compliance and efficient operations. Collaborating with staff and administration to promote quality care in a healthcare setting.
Clinical Director managing clinical services and staff operations for a mental health agency. Ensuring compliance and improving service delivery while leading a multidisciplinary team.
Clinical Development Medical Director ensuring scientific integrity and well - being in clinical trials. Leading studies and delivering key clinical outcomes while maintaining compliance and managing risks.
Medical Director overseeing healthcare providers at CHN health center. Delivering medical services and mentoring residents while ensuring the successful execution of Community Healthcare Network's mission.
Medical Director/Clinician overseeing clinical affairs at a health center serving underserved communities. Engaging with a dynamic healthcare team in New York City.
Assistant Regional Clinical Director overseeing clinical operations for ABA services provided to individuals with Autism Spectrum Disorder. Leading BCBAs and driving quality and effectiveness across multiple states.
Global Medical Affairs Director at ViiV Healthcare ensuring effective communication of HIV prevention research. Leading training and data compliance efforts for clinical specialists and outside health care providers.
Medical Director at Elevance Health responsible for the administration of healthcare services and improving quality outcomes. Ensuring efficient cost - effective medical care and supporting clinicians in their roles.
Clinical Director at AMFM Healthcare overseeing outpatient mental health programs and ensuring quality care delivery. Collaborating with multiple stakeholders to manage programs and support staff in clinical supervision.