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Our client is a growing northern CA company dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology is in search of the following professional:
Senior Director, Clinical Research & Medical Monitor
The Senior Director, Clinical Research & Medical Monitor will work 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.
Provide input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations. Reporting directly to the Vice President, Clinical Research, this individual will also be the primary Medical Monitor for all clinical studies conducted under his/her 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 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
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.
Board certified with an active US medical license is desirable, but not required
8+ years’ total clinical research experience with at least 5+ years working for a biopharmaceutical organization with primary responsibility for Clinical Research/Medical Monitoring
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
Highly competitive base salary, plus benefits and incentives including relocation.