Director, Medical Safety Officer, Oncology

About the role

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

Responsibilities

• 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.
• Communicate potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head, 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.
• In compliance with legal and regulatory requirements, lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.

Requirements

• Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required.
• Board Certified/Board Eligible/equivalent preferred.
• Medical specialization preferred.
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
• Demonstrated 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 highly preferred.
• Ability to influence, negotiate and communicate with both internal and external stakeholders.
• Experience with Health Authority presentations is preferred.

Qualifications

• Minimum Qualification: Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required.
• Preferred Qualification: Board Certified/Board Eligible/equivalent preferred.
• Medical specialization preferred.
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
• Demonstrated 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 highly preferred.
• Ability to influence, negotiate and communicate with both internal and external stakeholders.
• Experience with Health Authority presentations is preferred.

Skills

• Ability to lead global cross-functional teams effectively and strategically.
• Connect, collaborate, and build consensus across relevant functions.
• Think strategically, have a global mindset, big picture orientation.
• See the context of the entire situation, understand implications to the business.
• 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.
• 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 are also desirable.
• Fully fluent in written and spoken English.
• Proficiency in Word and PowerPoint is desired.

Pay

The anticipated base pay range for this position is: $199,000.00 - $343,850.00

Benefits

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits