Product Safety Head (Sr Director) - Solid Tumors

Johnson & Johnson Innovative Medicine•Horsham, PA

9d•$196,000 - $343,000

About The Position

The Product Safety Head – Solid Tumors oversees deliverables and provides strategic direction to Medical Safety Officers (MSOs) and Safety Analysis Scientists leading product safety strategy and risk management activities in Global Safety Strategy & Risk Management (GSSRM). The role oversees end-to-end medical safety strategy for assigned marketed and developmental products, determines whether safety risk mitigation measures are needed, and supports efficient safety activities through aligned processes, systems, practices, and new approaches to scientific safety evaluation. The role ensures proactive, timely assessment of safety data and understanding of emerging and known product safety profiles. It oversees preparation of aggregate safety reports and responses to health authorities, and supports appropriate communication of potential and known risks to senior management, health authorities, prescribers, and patients. The Product Safety Head maintains compliance with legal and regulatory requirements and leads safety risk management activities across products’ lifecycles.

Requirements

MD or equivalent.
10 or more years of substantial pharmaceutical industry experience; clinical experience is highly preferred.
Management experience supervising a group of employees, demonstrated strong Credo values, proven leadership skills, and ability to thrive in a global, matrix environment.
Significant skills in clinical medicine and pharmacovigilance, including post-marketing safety assessment experience.
Knowledge of oncology products, associated pharmacovigilance guidelines, and the global regulatory framework.
In-depth knowledge of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, benefit-risk assessment, and safety assessment of marketed and developmental compounds.
A track record of handling difficult safety issues and clinical safety data, interacting with domestic and international regulatory departments and agencies, and collaborating and networking effectively.
Ability to manage multiple critical issues simultaneously, critically evaluate data from sources such as clinical trials, post-marketing environments, and literature, and assess strategic importance.
Ability to influence, negotiate, and communicate with internal and external customers.
Ability to develop, implement, communicate, and influence policy and strategy internally and externally.
Excellent verbal and written communication skills, including formal presentation skills.
Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements, clinical trial conduct, and appropriate contributions to regulatory filings, pharmacovigilance documents, and risk management plans.
Fluent written and spoken English.
Working knowledge of Microsoft software, including Excel and Word.

Nice To Haves

Clinical experience.
Oncology therapeutic area experience.
Publication and journal article writing experience.
Experience presenting to technical and lay groups at public meetings.
Skills in Clinical Operations, Compliance Management, Compliance Risk, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medicines and Device Development and Regulation, Operations Management, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented practices, Serious Adverse Event Reporting, Standard Operating Procedures (SOPs), and Tactical Planning.

Responsibilities

Shape safety strategy and risk management for assigned J&J Pharmaceutical products during drug development and post-marketing.
Partner with the TASH, the Head of GSSRM, the Chief Safety Officer, the Chief Medical Officer for JJ IM, the Qualified Person for Pharmacovigilance for JJ IM, other JJ IM R&D leaders, and groups within GMS to proactively assess, respond to, and communicate product safety concerns throughout the product lifecycle.
Provide oversight, medical expertise, and leadership to Product Medical Safety Officers and safety analysis scientists for the end-to-end medical safety strategy of assigned products.
Provide input into key regulatory documents, including ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERs/PSURs, and REMS/RMPs, and serve as the designated GMS leader and signatory on program Labeling Committees.
Work with Clinical TA, Medical Affairs, Global Regulatory Affairs, and the QPPV Pharma to implement and ensure compliance with post-marketing risk management commitments.
Work with GSSRM TASHs and TALs, the QPPV Pharma, and other GMS functions to align medical safety processes, implement process improvements, and improve operational efficiency.
Serve as the Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee.
Provide input on pharmaceutical licensing and acquisition candidates.
Support the TASH and GSSRM Head in managing the annual budget and planned resource allocation to meet portfolio objectives.
Support regulatory inspection readiness, inspections, and CAPAs.
Develop or revise SOPs as a Business Process Owner or functional stakeholder.
Promote diversity, equity, and inclusion; hire and retain diverse talent; and foster an inclusive community.
Act ethically and responsibly, keeping patient safety paramount.
Provide leadership in written and verbal interactions with regulatory authorities concerning safety and risk management for the CTP.
Ensure drug safety activities and processes comply with global legislation and regulatory requirements.
Attract, retain, and develop talent, and build teams that support organizational effectiveness, transparency, and communication.