Global Medical Safety Physician, Immunology, Director-6112120926
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Global Medical Safety Physician, Immunology, Director. This position is based in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Global Medical Safety (GMS) Physician, Immunology, will report to and assist the GMS Therapeutic Area (TA) Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The GMS Physician will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Johnson & Johnson pharmaceutical products.
Principal responsibilities for the GMS Physician include: provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff, provide end-to-end (Phase 1 through product life cycle) safety support and surveillance; chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products; participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head; present medical safety and risk management evaluations as necessary to the CSO, the GMS Senior Leadership Team, and the Global Safety Council; provide input and review to key regulatory or clinical documents as appropriate, to ensure these key safety documents are of high medical and scientific quality; work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues; assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management; and participate on due diligence teams to evaluate Licensing & Acquisition opportunities.
An MD (or equivalent medical degree) is required. A Board Certification (or relevant national qualifications ex-US) in a relevant medical discipline is preferred. At least 5 years of post-residency/fellowship experience in clinical practice, academia, clinical research, or drug safety from the Pharmaceutical, Biotech or relevant industry experience is required, as is at least 2 years of post marketing safety or related industry experience, including experience preparing PSURs.
Also required and essential to success in this role are: proven ability to work in a cross-functional environment, demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations; the ability to influence, negotiate and communicate with both internal and external customers; the ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications; and experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.
Must be able to plan work to meet deadlines and effectively handle multiple priorities. Excellent verbal and written communication skills, including formal presentation skills are required. Written skills as evidenced by publication and journal articles are also desirable. Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Proficiency in PowerPoint is desired.
This position requires up to 10% annual travel.
Primary Location: North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science
Johnson & Johnson Family of Companies
- 3 years ago - save job
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