Senior Medical Director, Oncology

Responsibilities

• Design and implement Phase I to III clinical studies
• Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Provide scientific oversight for Company operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs
• Act as a clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Play a key role in the analysis, interpretation and delivery of high-quality clinical data
• Interact with principal investigators and opinion leaders to facilitate clinical trials research
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
• Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
• Develop and give internal and external presentations as subject matter expert for the therapeutic area
• Participate in the development and review of publications
• Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.

Qualifications and Technical Proficiencies

• Demonstrate strong clinical and scientific knowledge
• Be an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
• Be comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Preferred Skills, Qualifications and Technical Proficiencies

• MD, board-certified (or eligible)
• Expertise in Oncology
• A strong track record of scientific activity, demonstrated by publications in top tier journals
• At least 6+ years of relevant clinical development experience
• Relevant basic and/or clinical research experience in academic settings is viewed favorably