Director, Medical Safety Officer, Oncology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Oncology to be located in Raritan, NJ; Titusville, NJ or Horsham, PA. 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.

The MSO will report to the Product Safety Head and oversee the safety assessment of assigned drugs within the therapeutic area (TA) that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will also lead, when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.

Responsibilities include, but are not limited to the following:

• Strategically lead the Safety Management Teams (SMT) for assigned products.

  • SMT 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.

• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.

• Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.

• Be an active partner and core contributor of safety input to key regulatory or clinical documents including:

  • Risk management plans.

  • Safety development plan.

  • Clinical Trial Protocols.

  • Informed Consent Forms (ICF).

  • Safety Sections of Investigator’s Brochure (IB) and IB addenda.

  • Clinical Study Reports (CSR).

  • Annual Safety Reports (ASR).

  • Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings.
    Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).
    Health authority queries.

  • Core Data Sheets (CDS).

• Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).

• Actively participate and contribute to meetings with Health Authorities and external key opinion leaders.