Raritan, New Jersey; United States; Horsham, Pennsylvania; Titusville, New Jersey
The Therapeutic Area (TA) Safety Head, Oncology, is responsible for the overall supervision and strategic direction of one of the two oncology TA groups in Medical Safety Strategy (MSS) within Global Medical Safety (GMS), charged with overseeing the safety of both marketed products, as well as products in clinical development. In this position, the Therapeutic Area Safety Head (TASH) will be responsible for all solid tumor malignancy products. You will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of the relevant pharmaceutical products within the Oncology Therapeutic Area, and communication of potential and known risks, when appropriate, to Senior Management, Health Authorities, Prescribers and/or Patients. In compliance with legal and regulatory requirements, you will also contribute to and supervise, when appropriate, the design and implementation of processes to manage risk associated with the use of Johnson & Johnson Pharmaceutical products. You will also maximize efficiency and effectiveness by aligning safety-related activities around common processes, systems, and practices, and implementing new approaches to support the scientific evaluation of the safety profile of the assigned pharmaceutical products.
Key Responsibilities Include:
Oversee medical safety assessment for all Johnson & Johnson Pharmaceutical solid tumor products during drug development and post-marketing within the Oncology Therapeutic Area, including safety surveillance, risk assessment, and structured benefit/risk frameworks
Take responsibility for the strategy and oversee implementation of, and compliance with, post-marketing risk management commitments in collaboration with the relevant Oncology Therapeutic Area, Medical Affairs, Global Regulatory Affairs, and the Qualified Person for Pharmacovigilance (QPPV) Pharma
Partner closely and effectively with the relevant Oncology Therapeutic Area, the Head of Medical Safety Strategy, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) Pharma, the QPPV Pharma, other Pharmaceutical R&D leaders, and the other groups within Global Medical Safety (GMS) including Pharmacovigilance Evaluation and Reporting (PVER) in assessing, responding to, and communicating safety concerns for products in drug development and in the post-marketing setting
Provide leadership in regulatory authority interactions regarding safety and risk management for the relevant Oncology Therapeutic Area, both written and verbal
Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements
Provide input into key regulatory documents (e.g. Ad hoc reports, Health Hazard Evaluations, Clinical Overviews) and be a signatory when appropriate
Be the delegated signatory for Periodic Benefit-Risk Evaluations Report/Periodic Safety Update Report (PBRERS/PSUR) for the Qualified Person for Pharmacovigilance (QPPV) Pharma
Represent Global Medical Safety (GMS) on Label Review Committee
Coordinate safety topics within the relevant Oncology Therapeutic Area that are presented to Medical Safety Council
Ensure consistency across Global Medical Safety (GMS) on safety-related processes, including risk identification, assessment and management, and SOP training and implementation
Work closely with other Therapeutic Area Safety Heads, the QPPV Pharma, and other groups within Global Medical Safety (GMS) including Pharmacovigilance Evaluation and Reporting (PVER) in strategic planning and process improvements to maximize operational efficiency and ensure cohesive and coordinated approaches to best practices of clinical and post-marketing safety.
Provide consistent leadership and approach across relevant Therapeutic Area clinical teams for safety data collection, assessment, and addressing safety-related issues
Provide medical expertise to and oversight of the relevant Oncology Medical Safety Strategy (MSS) staff
Provide oversight and input on licensing and acquisition candidates
Provide leadership to the relevant Oncology Medical Safety Officers (MSO) and Scientists and other professionals by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
Promote sharing of knowledge between Medical Safety Strategy staff within the Therapeutic Area and facilitate the expansion of individual responsibilities and professional development
Participate in the annual budget setting process for the relevant Oncology Safety group, and proactively manage the budget and resource planning and allocation of individuals to meet the portfolio objectives throughout the year.
In this role, you will make medical decisions on scientific evidence of the potential relationship between relevant Oncology products and adverse events in support of the Medical Safety Officers. You will decide, with the Medical Safety Science and Risk Management Excellence Leader, Development Safety Excellence Leader, theHead of Medical Safety Strategy and the Chief Safety Officer (CSO), which issues require escalation to more senior management.
You will make risk management strategy decisions related to the relevant Oncology products in collaboration with the Medical Safety Officer, Risk Management Scientific Leads, the Medical Safety Science and Risk Management Excellence Leader, and Office of the QPPV, as appropriate.
Physician (MD or equivalent) with 10 or more years of substantial Pharmaceutical Industry experience; clinical experience highly preferred.
Significant skills in clinical medicine and pharmacovigilance, including experience in post-marketing safety assessment
Demonstrated in-depth 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
Consistent track record in dealing with difficult safety issues, clinical safety data, interactions with domestic and international regulatory departments / agencies, and strong collaborative and networking skills.
Ability to successfully manage multiple critical issues at a time, critically evaluate data from multiple sources (eg, clinical trials, post-marketing environment, literature), and assess the strategic importance of the data
Management experience in supervising a group of employees; demonstrated strong CREDO values; proven leadership skills; ability to thrive in a global, matrix environment.
Ability to influence, negotiate and communicate with both internal and external customers.
Ability to develop, implement, communicate and influence policy and strategy internally and externally to the company
Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.
Experience presenting to technical and lay groups at public meetings desirable.
Knowledge of Good Clinical Practices and PV regulatory requirements, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.
Fluent in written and spoken English
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.