Director, Medical Safety Officer, CV-Met & Infectious Disease.

Company: Johnson & Johnson
Location: Titusville
Posted on: January 15, 2022

Job Description:

Janssen Research & Development, L.L.C., a member of Johnson & Johnson Family of Companies, is looking for a Director, Medical Safety Officer (MSO) located in Titusville, NJ, Raritan, NJ or Horsham, PA!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies is part of the Janssen Pharmaceutical Companies.

The Director, Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Janssen products and will strategically lead cross-functional teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as a product spokesperson regarding overall benefit/risk.

The MSO will report to the Therapeutic Area Safety Head (TASH) for CV-Met & Inf Dis and lead all aspects of the safety and benefit/risk assessment of assigned pharmaceutical products that are marketed and/or in clinical development within the Immunology TA. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of their products relative to their potential benefit to patients. The MSO will be the primary point of contact for safety concerning his/her assigned products and clinical programs and will communicate potential and known risks and changes to benefit/risk, when appropriate, to the TASH, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients.

This role requires leadership of cross-functional Safety Management Teams (SMT) for assigned products or clinical programs, with key responsibilities including, but not limited to, signal detection, benefit/risk assessment and risk management activities (e.g., label updates, urgent safety measures). Other responsibilities include participating in strategic planning of clinical protocols and development programs and patient-centered decision-making, as well as ownership of aggregate reports (e.g., PBRER/PSUR). The Medical Safety Officer will present (either orally or in writing) the Company's scientific position with regard to safety in support of regulatory filings and in response to Health Authority requests. The MSO will be an integral member of due diligence teams and have a seat at the table for go/no-go decisions on Licensing and Acquisition opportunities within the CV-Met & Inf Dis portfolio.

This role relies upon strong foundational knowledge in medicine as well as the ability to engage, influence, and mobilize teams.

Required

Qualifications
Physician (MD or equivalent) with 6+ years related experience.
A minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research in pharmaceutical industry or academic setting)
Demonstrated skills in clinical medicine with at least 4 years of clinical practice experience, which includes a residency program or equivalent)
Ability to critically evaluate safety data from multiple sources (clinical trials, post-marketing, and literature, etc.)
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
Ability to see the context of the entire situation, understand implications to the business.
Ability to influence, negotiate and communicate with both internal and external stakeholders
Excellent writing skills as evidenced by publication and journal articles
Proficiency in Word and PowerPoint

Preferred
Board Certification
Basic understanding of drug development, pharmacology, clinical trial methodology and design, and assessment of drug benefits vs. risks is a must. Knowledge of biostatistics and epidemiology
Experience with structured benefit-risk frameworks (e.g., BRAT, FDA) and current regulatory policy on benefit-risk assessment and patient-focused drug development
Experience with formal Health Authority presentations
Experience with combination pharmaceutical products

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105985690W

Keywords: Johnson & Johnson, Trenton , Director, Medical Safety Officer, CV-Met & Infectious Disease., Healthcare , Titusville, New Jersey