Medical Director- Immuno-Oncology at Judge Group
Rockville, MD
About the Job
Salary: $230,000.00 USD Annually - $280,000.00 USD Annually
Description: Our client is currently seeking a Medical Director- Immuno-Oncology
Medical Director will participate in all aspects of in-house clinical programs and trials. The role will serve as a medical expert provide therapeutic and medical expertise. The ideal candidate will be responsible for medical monitoring and safety oversight for investigational products, primarily for medical reviews/assessments of adverse event reports, safety signal, and risk management, as well as support aggregate and final safety reports’ preparation. A medical background for oncology and immunology is required.
This job will have the following responsibilities:
RESPONSIBILITIES :
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation all study startup/conduct/close-out activities as applicable
- Perform Site-facing activities such as training and serving as primary contact for clinical questions
- Perform activities relating to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting clinical science team
- Develop clinical narrative plan; review clinical narratives
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Draft/review and validate of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
- Attends and presents at Investigator Meetings.
- Performs review and clarification of trial-related Adverse Events (AEs)
- May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
Qualifications & Requirements:
- MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent), with oncology and immunology background.
- Minimum of 5 years of experience in clinical development in a biopharmaceutical industry setting or equivalent
- Excellent scientific/clinical and analytical knowledge base, with the ability to assess data and understand the safety/medical implications.
- Demonstrated working knowledge of ICH/GCP and FDA regulations relevant to patient safety and adverse event reporting, including periodic safety reporting.
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Contact: arawat@judge.com