Janssen Research & Development, LLC, is recruiting for a Therapeutic Area (TA) Safety Head, Immunology to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Therapeutic Area (TA) Safety Head, Immunology, is responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within the Immunology Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM). The TA Safety Head (TASH) is charged with overseeing end to end medical safety strategy of both marketed products and products in clinical development within the assigned TA and determine the need for safety risk mitigation measures. The TASH will also maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices, and implementing new approaches to support the scientific evaluation of the safety risk profile of assigned pharmaceutical products. In this role, the TASH will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products in the TA portfolio, preparation of aggregate safety reports and responses to Health Authorities (HA) and, when appropriate, communication of potential and known risks to Senior Management, HAs, Prescribers and/or Patients. The TASH maintains compliance with legal and regulatory requirements.
Responsibilities include but are not limited to the following:
- Shape the safety strategy and risk management for all J&J Pharmaceutical products during drug development and post-marketing within the assigned TA
- Partner closely and effectively with the Immunology TA, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) Pharma, the Qualified Person for Pharmacovigilance (QPPV) Pharma, other Pharmaceutical R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle
- Connect with respective colleagues in the Clinical TA, Medical Affairs, Global Regulatory Affairs and the QPPV Pharma for the implementation and compliance of post-marketing risk management commitments.
- Provide oversight, medical expertise and leadership to the Immunology Medical Safety Officers (MSO), SAS TAL and their direct report Scientists for the end-to-end medical safety strategy of their assigned products
- Grow, attract, retain, and develop top talent, and build teams to ensure organizational effectiveness, transparency, and communication.
- Create a workforce that is reflective of global diversity by promoting diversity, equity, and inclusion in the organization and by hiring and retaining diverse talent and fostering a community that supports inclusivity
- Act ethically and responsibly to ensure patient safety is paramount
- Provide leadership in regulatory authority interactions regarding safety and risk management for the TA, 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, PBRERS/PSURs, REMS/RMPs) and serve as the designated GMS leader and signatory on TA Labeling Committee
- Coordinate safety topics within assigned TA that are presented to Medical Safety Council
- In collaboration with other TASHs and TALs, ensure consistency of medical safety-related processes across TAs to ensure cohesive and coordinated approaches to best practices of clinical and post-marketing safety, working with QPPV Pharma and other GMS functions to implement needed process improvements and maximize operational efficiencies
- Serve as the Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee
- Provide input on licensing and acquisition pharmaceutical candidates
- Support GSSRM Head in proactively managing of the annual budget and planned resource allocation of individuals to meet the portfolio objectives throughout the year.
- Support regulatory inspection readiness, inspections, and CAPAs
- Develop or revise SOPs as Business Process Owner or functional stakeholder
Education and Experience:
- Physician (MD or equivalent) with a minimum of 10 years of substantial Pharmaceutical Industry experience OR a minimum of 7 years Pharmaceutical Industry experience combined with 3 years of clinical experience.
- Prior clinical experience highly preferred.
- Immunology therapeutic area experience preferred
- Management experience in supervising a group of employees; demonstrated strong CREDO values; proven leadership skills; ability to thrive in a global, matrix environment.
- 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
- Proven 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 simultaneously, critically evaluate data from multiple sources (eg, clinical trials, post-marketing environment, literature), and assess the strategic importance of the data
- 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
Required Technical Knowledge and Skills:
- 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
The anticipated base pay range for this position is $213,000 to $368,000.
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.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.