Medical Director for Oncology and Hematology Clinical Development
6 days ago
This is a leadership position responsible for overseeing the direction, planning, execution, and interpretation of clinical trials or research activities in oncology and hematology clinical development.
About UsA global leader in healthcare, AbbVie is dedicated to transforming people's lives through innovative solutions. Our mission is to discover and deliver breakthrough medicines that solve some of the world's most pressing health issues. We're driven by a passion for making a remarkable impact on people's lives across multiple therapeutic areas – immunology, oncology, neuroscience, and eye care.
Key Responsibilities- Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, customer needs, market trends, business operations, and emerging issues.
- Oversight of clinical studies, monitoring overall study integrity, reviewing, interpreting, and communicating accumulating data pertaining to safety and efficacy of molecules.
- Responsible for assessing and reporting serious adverse events per corporate policy and regulations for assigned protocols.
- Design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses, as well as other program documents.
- Proactive monitoring of clinical trial safety conducted in collaboration with ABV CTPS (Clinical Trial Patient Safety).
- Evaluating all safety data generated in clinical trials and responding to safety questions from investigator sites and IRBs regarding safety issues and queries.
- M.D. or equivalent (D.O.) and completion of an Oncology Residency, Board certification (or equivalent in ex-US countries) preferred.
- 5-7 years of experience in medical monitoring of clinical trials required or having relevant clinical development/pharma experience would be considered.
- Track record of successful management of product safety matters (labeling negotiation, etc.) preferred.
- Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports, and company core safety information highly desirable.
- A comprehensive compensation package, including an estimated salary range of $180,000 - $220,000 per year, paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) eligibility.
- Short-term and long-term incentive programs for eligible employees.
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