Associate Director, Medical Safety Officer (Oncology- Solid Tumors)

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 an Associate Director, Medical Safety Officer (Oncology- Solid Tumors) to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.

Johnson and Johnson Innovative Medicine (JJ IM) Associate Medical Safety Officer (aMSO) has accountability for assessing the medical safety of assigned Janssen products and will work closely with an experienced Medical Safety Officer to strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.

The aMSO will work under the supervision of an experienced. MSO and will report to the GMS Therapeutic Area Safety Head (TASH) or Senior Director Product Safety Head and oversee the safety and benefit/risk assessment of assigned products within the Solid Tumor TA that are marketed and/or in clinical development. Collaborating with relevant functions, the aMSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit-risk assessment of assigned products within the TA. The aMSO will communicate potential and known risks and changes to benefit/risk, when appropriate, to the experienced. MSO, Senior Director Product Safety Head, TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), JJ Innovative Medicine Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) JJ IM, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the aMSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.

Duties and responsibilities include, but are not limited to the following:

Working closely with an experienced MSO

• Execute on the Global Medical Safety organization's strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Safety Officer
• Serve as a subject matter expert in the therapeutic area and patient risk management throughout the product life cycle
• 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 (e.g., Product Safety Strategy, Program Safety Analysis Plan)
• Build collaborative partnerships with other GMS groups and functional stakeholders including, but not limited to Clinical TA, Non-Clinical Safety, Global Epidemiology, Regulatory Affairs, Biostatistics, and Medical Affairs
• 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 and Medical Affairs teams to minimize/mitigate patient impact by active participation in the design of protocols.
• Be an active partner and core contributor of safety input to key regulatory or clinical documents including:
  • Risk management plans
  • Clinical Trial, EAP and IIS Protocols
  • Informed Consent Forms (ICF), including Risk Language
  • Safety Sections of Investigator's Brochure (IB) and IB addenda
  • Safety sections of Clinical Study Reports
  • Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings
  • Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR), Development Safety Update Report (DSUR)
  • Health authority queries
  • Company Core Data Sheets (CCDS), US and EU prescribing information
  • Signal Evaluations
• Assess product benefit-risk balance and offer medical input in the conduct of Proactive Safety Reviews and the generation of signal evaluations, structured Benefit-Risk Assessments, Health Hazard Evaluations, Product Safety Strategy documents (PSS), and Risk Management Plans and aggregate and other safety reports, including risk categorizations and minimization activities.
• Review and provide input on additional risk mitigation strategies, product labeling and internal and customer safety training materials directed to minimize patient risk and reduce adverse treatment outcomes
• 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 JJ IM Medical Safety Council (MSC)
• Contribute to the planning and preparation of meetings with Health Authorities and external key opinion leaders on important safety topics and risk management strategies
• Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management
• Actively participate in department-wide initiatives

Education and Experience:

• Physician (MD or equivalent), generally requires 0-3 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research, Medical Affairs)
• Board Certification (if US) preferred
• Medical specialization preferred
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience
• 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 is preferred
• Ability to influence, negotiate and communicate with both internal and external stakeholders
• Experience with Health Authority presentations is preferred.

Required Technical Knowledge and Skills:

• Connect, collaborate and build consensus across relevant functions
• Ability to think strategically, has a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business
• 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.
• 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 is desirable
• Able to plan work to meet deadlines and effectively handle multiple priorities
• Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
• Fluent in written and spoken English
• Proficiency in Word and PowerPoint is desired

The anticipated base pay range for this position is $159,000 to $274,850.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found via the following link: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.