Executive/Senior Medical Director providing medical leadership for oncology drug development at Verastem. Managing clinical studies and ensuring compliance in a hybrid work environment.
About the role
- Medical Advisor overseeing oncology-related clinical projects within a global medical research organization. Providing scientific guidance and medical support to project leaders and clinical teams.
Responsibilities
- Medical Monitoring: Primarily serves as Global Medical Advisor on assigned projects
- Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects
- 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)
- Provides therapeutic area/indication training for the project clinical team
- 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 narrative, in collaboration with the Pharmacovigilance department
- May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department
- May perform medical review of adverse event coding
- Performs review of the Clinical Study Report (CSR) and patient narratives
- Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
- Available 24/7 to respond to urgent protocol-related questions from investigative sites, in accordance with local labor laws
Requirements
- Other Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
- Typically requires a minimum of 5-7 years' experience in clinical medicine
- Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research
- Business Acumen
- Current or prior license to practice medicine; Clinical experience in the requested medical specialty. A board-certification for the required therapeutic area is preferred
Benefits
- May require regular travel
- Extensive use of keyboard requiring repetitive motion of fingers
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Medical Director leading clinical trial development and oversight at Pfizer. Focusing on GU oncology with responsibilities including medical monitoring and strategic guidance.
Global Medical Affairs Director at ViiV Healthcare leading strategic analysis and program design for HIV treatments. Ensuring deep medical expertise on ViiV medicines through cross - functional collaboration within Medical Affairs.
Chief Medical Officer leading medical and scientific advisory at FemTech startup hermaid. Driving innovation and digital solutions for women's health, focusing on menopause and beyond.
Chief Medical Officer leading medical staff and quality initiatives at Trinity Health Livonia Hospital. Overseeing strategic plans and medical staff development with a focus on community health.
Associate Medical Director providing medical/scientific expertise in safety evaluation and risk management of GSK assets. Ensuring patient safety while collaborating across teams in clinical development and post - marketing settings.
Medical Affairs Director at ViiV Healthcare leading medicine readiness programs and training initiatives. Focused on HIV and collaboration across Medical Affairs organization.
Strategic Global Medical Director for Pfizer's Respiratory pipeline, advocating for development and executing clinical strategies. Leads cross - functional alignment to address patient needs and deliver innovative therapies.
Chief Medical Officer providing leadership and quality care at Saint Francis Hospital. Overseeing medical staff and implementing strategic healthcare plans within a large integrated system.
Medical Director Associate role at CarelonRx focusing on pharmacy prior authorizations and clinical guidance. Collaborate with clinicians and physicians for compliance and timely approvals.