As an Associate Medical Director, you will support the ongoing and planned execution of the Oncology trials and contribute to clinical development planning for 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
The pay range that the Company reasonably expects to pay for this headquarters-based position is $229,300-$269,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
