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.
· As the Medical Director in Global Clinical Development, you will serve as the medical lead for clinical trials, providing oversight for the execution of clinical trial activities in assigned oncology/immune-oncology projects. Your role will involve managing clinical trial activities to best support the overall program strategy and leading the planning and management of clinical trials, including study design, trial management, data assessment, interpretation, and publication of results from a medical perspective.
· 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
Education & Languages:
· MD or equivalent medical degree is required, in addition to extensive knowledge and clinical training in medical/scientific areas, RTL.
· Board certification or training in Medical Oncology or Internal Medicine preferred but not mandatory.
· Proficient in effective communication in English.
· Demonstrated good medical writing skills
Professional Skills & Experience:
· Substantial professional experience in oncology, particularly in clinical trials, preferably late phase clinical trials.
· At least 5-7 years of experience in the pharmaceutical or biotechnology industry, including knowledge of regulatory requirements in clinical development.
· Proven experience in the design, setup, conduct, and evaluation of clinical trials in oncology.
· Background in working in a cross-functional, multi-site team environment.
· Experience in immuno-oncology and/or oncology research Preferred .
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