Director, Medical Safety Officer, Oncology

Johnson & Johnson Innovative Medicine•Horsham, PA

3d•Hybrid

About The Position

Johnson & Johnson is seeking a Director, Medical Safety Officer, Oncology, based in Titusville, New Jersey; Raritan, New Jersey; or Horsham, Pennsylvania. The Pharmaceuticals Medical Safety Officer (MSO) is accountable for assessing the medical safety of assigned products and strategically leading cross-functional matrix teams responsible for product safety and benefit-risk oversight. The MSO represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk. Reporting to the Product Safety Head, Cellular Therapy, Hematology, the MSO oversees safety and benefit-risk assessment for assigned products within the Hematology therapeutic area that are marketed and/or in clinical development. Working with relevant functions, the MSO ensures proactive, timely assessment of safety data to characterize emerging and known safety profiles and benefit-risk. The MSO communicates potential and known risks and benefit-risk changes to relevant leadership and stakeholders, including health authorities, prescribers, and patients when appropriate. In compliance with legal and regulatory requirements, the MSO also leads the design and implementation of risk mitigation strategies to support the safe and appropriate use of Innovative Medicine products. The role provides medical and scientific safety expertise across product development, clinical and regulatory work, safety surveillance, risk management, and cross-functional initiatives. It includes oversight of safety assessments prepared by contractors and non-physician staff, participation in health authority and external expert meetings, and contributions to department-wide processes and initiatives.

Requirements

MD or equivalent physician qualification.
Two to five years of pharmacovigilance experience or other relevant experience, such as clinical research, Medical Affairs, or clinical experience.
At least one year of clinical practice experience, with demonstrated clinical medicine skills.
Ability to lead global cross-functional teams effectively and strategically.
Ability to collaborate and build consensus across relevant functions.
Strategic thinking, a global mindset, big-picture orientation, and ability to understand business context and implications.
Ability to critically evaluate safety data from multiple sources, assess clinical importance and potential strategic impact, and communicate findings clearly in writing and orally.
Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements in the United States, European Union, and globally, as well as clinical trial conduct and contributions to regulatory filings, pharmacovigilance documents, and risk management plans.
Ability to plan work to meet deadlines and manage multiple priorities effectively.
Excellent verbal and written communication skills, including formal presentation skills.
Fluency in written and spoken English.

Nice To Haves

Board Certified, Board Eligible, or equivalent.
Medical specialization.
Demonstrated knowledge of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, drug benefit-risk assessment, safety assessment of marketed and investigational drugs, and global safety regulations.
Experience presenting to health authorities.
Publication and journal article writing experience.
Proficiency in Word and PowerPoint.

Responsibilities

Strategically lead Safety Management Teams for assigned products, including safety surveillance, signal detection, and risk management activities such as RMPs and REMS.
Provide medical and scientific expertise as the Global Medical Safety representative on Compound Development Teams and Clinical Teams.
Anticipate safety concerns and participate in clinical protocol design to help minimize or mitigate patient impact.
Contribute safety input to regulatory and clinical documents, including risk management plans, safety development plans, clinical trial protocols, informed consent forms, investigator brochures and addenda, clinical study reports, annual safety reports, integrated safety summaries, summaries of clinical safety, PBRERs/PSURs, health authority queries, and core data sheets.
Communicate important results of medical safety and benefit-risk evaluations to GMS leadership, the CMO, and the Medical Safety Council when necessary.
Participate in meetings with health authorities and external key opinion leaders.
Provide medical safety leadership on due diligence teams evaluating licensing and acquisition opportunities.
Provide medical oversight to contractors and non-physician staff preparing written safety evaluations by defining the safety question, developing the review strategy, interpreting results, determining medical importance, and reviewing and approving assessment reports.
Work across GMS therapeutic areas to align and improve processes and promote a harmonized approach to safety data collection, assessment, and safety-related matters.
Assist in creating, reviewing, and implementing SOPs, work instructions, guidelines, documents, and tools related to safety assessment and risk management.
Lead or actively participate in department-wide initiatives.