Global leadership role accountable for defining and delivering the medical strategy for Radioligand Therapies at Novartis. Shaping patient access and evidence generation strategies for oncology assets in the RLT portfolio.
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
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