Director/Senior Director, Clinical Research & Medical Monitor
The Director/Senior Director, Clinical Research & Medical Monitor will actively participate in all aspects of Clinical Research working collaboratively with the Clinical Study Team contributing to the strategic planning and execution of Clinical Development Plans for compounds in hematology and oncology clinical development. This individual will work within the group to formulate strategic portfolio development across programs and within individual programs as appropriate which may include evaluation of agents for potential collaboration. This individual will be responsible for providing input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations to the highest scientific standards. Reporting directly to the Senior Vice President, Clinical Research & Regulatory Affairs, this individual will also be the primary Medical Monitor for all clinical studies conducted under their responsibility, and contribute to/provide medical review, analysis, and interpretation of data from clinical studies.
- Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage
- Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials
- Collaborate with the preclinical and Translational groups at the Cambridge site to assure alignment of Translational Medicine strategy
- Collaborate with Project Management, Clinical Operations, Clinical Science, and Medical Writing departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and different scientific presentations.
- For assigned programs/studies, lead the efforts in preparing for conference presentations such as AACR, ASCO, and ASH, and writing and reviewing manuscripts based on the database and CSR
- This individual will be responsible for the clinical and medical content of all clinical and regulatory documents and will ensure the scientific accuracy of all study-related documents
- Identify program risks, and creates and implements mitigation strategies with Clinical Operations
- Responsible for review and analysis of clinical data including safety monitoring in collaboration with Drug Safety
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign-off clinical documents with respect to medical relevance.
- MD degree
- Oncologist or hematologist-oncologist highly preferred
- Board certified with an active US medical license is desirable, but not required
- Minimum 1 year clinical research experience plus at least 3 years working for a biopharmaceutical organization with primary responsibility for Clinical Research/Medical Monitoring
- Experience treating patients required.
- Knowledge of key opinion leaders in the areas of oncology/hematology highly desirable
- Familiar and comfortable with clinical concepts, practices, and FDA regulations regarding clinical research trials, experience with FDA interactions leading to drug approvals strongly preferred
- Familiar with data processing methods plus general knowledge of clinical medicine, oncology, and medical terminology
- Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting, and respectful relationships with colleagues at all levels within and outside the organization
- Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills, and execute position responsibilities with minimal guidance