Associate Medical Director, Oncology

Responsibilities:

• Act as a clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
• Provide scientific oversight for Company operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs
• Design, develop and, implement clinical studies for the applicable drug candidate, from Phase I through Phase III
• Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Acts to 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
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
• Develop and give internal and external presentations as subject matter expert for the therapeutic area
• Participate in the development and review of publications
• Prepare and monitor clinical trial budgets in collaboration with clinical operations and R&D finance
• Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.
• Serve as liaison to the commercial team on medical issues

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrate strong clinical and scientific knowledge
• Excellent communication skills with proven leadership experience and the ability to interact in a cross functional environment
• Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities

Preferred Education and Experience:

• MD, board-certified (or eligible), preferably in Oncology
• 2+ years’ clinical development experience in the biotechnology/pharmaceutical industry or an academic clinical trial unit
• A proven track record of scholarly clinical research demonstrated by publications in top-tier journals