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 Position ID: af-srdrgsft-m
Job Category: Biotech/R&D/Science
Type: Full Time, Employee
Minimum Education: Doctorate
Global pharma giant seeks senior drug safety MD with early phase experience Our client, one of the industry leaders in global oncology, is looking for an experienced drug safety physician with experience in translational medicine and/or clinical pharmacology to be responsible for the management of drug safety within an exciting new department. This position will be based in northern New Jersey at the company’s US headquarters. If you are a drug safety physician and would like to enhance your career, please email a Word document of your resume to afiore@kleinhersh.com If this opportunity does not match your interest, we have a number of additional roles that could work for you. Responsibilities: Responsible for the management of drug safety as it pertains to early phase development. Oversees medical and safety aspects on assigned own, and on drugs of team members of own Unit. Supervises and leads scientific approach of team members in analysis and management of potential risks related to the assigned drugs. Is accountable for compliance in signal detection, analysis and documentation of safety signals and appropriate risk management within assigned drug group. Functions as Brand Safety Leader for one assigned product. - Day-to-day management of assigned IMS team members.
- Prepares objectives and evaluates related performance for the assigned members.
- Provides guidance on, and initiates/maintains productive cross-functional medical safety collaborations internally with colleagues from Global IMS line functions, and Business Unit Oncology (OBU) functions such as Drug Regulatory Affairs, Statistics, Pharmacoepidemiology, Legal, or other related departments, and externally with Expert Panels and other external scientific contacts.
- Ensures that the safety risks with projects/products are identified promptly, and appropriately analyzed, monitored and handled within the assigned group. This includes oversight of use of signal detection tools such as SIGNS and other applications and/or of safety intelligence sources for potential product signals.
- Ensures that medical safety signals from aggregate data are communicated appropriately,including documents such as Safety Profiling Plans, Risk Management plans, and supporting documents for label changes.
Requirements: - Education (minimum/desirable): Medical Degree required. Specialty Board certification desirable.
- Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.
Experience/Professional requirement: - 3 years medical experience postdoctoral
- Experience in either translational medicine and/or clinical pharmacology and/or toxicology
- At least 5 years in industry or health authority or CRO (of which 2 years in a global position), including a minimum of 3 years in drug safety
- Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory reports
- Experience in leading cross-functional, multi-cultural teams
- Experience in preparing RMPs, PSURs, Submission dossiers (SCS).
Our client is offering a very attractive compensation package, which includes a full relocation package, and the benefits package (medical, dental, 401K, etc.) is among the best in the industry. If you are a drug safety physician and would like to enhance your career, please email a Word document of your resume to afiore@kleinhersh.com If this opportunity does not match your interest, we have a number of additional roles that could work for you. Visit www.kleinhersh.com to view additional job opportunities available through our company
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