Adverse Events, Analysis Skills, Artificial Intelligence (AI), Best Practices, Biotech and Pharmaceutical, Budgeting, Business Processes, Cell Analysis, Clinical Data, Clinical Medicine, Clinical Pharmacology, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Community Support, Data Analysis, Disease Prevention and Control, Diversity, Drug Development, Drug Products, Employee Retention, English Language, Financial Reporting, GCP (Good Clinical Practices), Healthcare, Hematology, Industry/Trade Analysis, Leadership, Licensing, Maintain Compliance, Marketing, Marketing Strategy, Medical Affairs, Medical Products, Medicine, Mentoring, Microsoft Excel, Microsoft PowerPoint, Microsoft Product Family, Microsoft Word, Modeling Languages, Negotiation Skills, Operational Strategy, Operations Management, Organizational Development/Management, Patient Safety, Pharmacovigilance, Presentation/Verbal Skills, Process Improvement, Product Development, Product Lifecycle, Product Management, Product Safety, Product Strategy, Productivity Management, Publications, Quality Control, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Resource Management, Risk, Risk Analysis, Risk Management, Safety Process, Standard Operating Procedures (SOP), Strategic Analysis, Strategic Planning, Talent Management, Team Lead/Manager, Team Player, Technical Presentation, Technical Writing, Time Management, Writing Skills
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Job Function:
Product Safety
Job Sub Function:
Product Safety Risk Management MD
Job Category:
People Leader
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
The Product Safety Head is responsible for the safety oversight and strategic direction for multiple cellular therapy products within the hematology therapeutic area. The Product Safety Head oversees a team of Medical Safety Officers (MSOs) leading product safety strategy and risk management activities in Global Safety Strategy & Risk Management (GSSRM). The Product Safety Head is charged with overseeing end to end medical safety strategy of both marketed and developmental phase activities of all the products within the assigned product and determine the need for safety risk mitigation measures. The Product Safety Head 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 product. In this role, the Product Safety Head will ensure E2E support for complex development plans, regulatory submissions, and post marketing risk minimization requirements across multiple products.
The Product Safety Head will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products within the assigned product, 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 Product Safety Head will ensure consistency of safety strategy execution and communications across multiple products within the assigned product. The Product Safety Head maintains compliance with legal and regulatory requirements.
Responsibilities:
- Shape the safety strategy and risk management for all the products within the assigned product during drug development and post-marketing
- Partner closely and effectively with the TASH, the Head of Global Safety Strategy and Risk Minimization (GSSRM), the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) JJ IM, the Qualified Person for Pharmacovigilance (QPPV) JJ IM, other JJ IM R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle
- Provide oversight, medical expertise and leadership to the product Medical Safety Officers (MSO) and the safety analysis scientists for the end-to-end medical safety strategy of their assigned products
- 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 product Labeling Committee, Protocol Review Committee, or Data Review Committee, as appointed by the TASH.
- 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.
- In collaboration with GSSRM TASHs and TALs, ensure consistency of medical safety-related processes 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
Other Duties:
- Serve as the Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee, as appointed by the TASH
- Provide input on licensing and acquisition pharmaceutical candidates
- Support TASH and GSSRM Head in proactively managing of the annual budget and planned resource allocation of individuals to meet the Product objectives throughout the year.
- Support regulatory inspection readiness, inspections, and CAPAs
- Develop or revise SOPs as Business Process Owner or functional stakeholder
- 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 CTP, both written and verbal
- Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements
- Grow, attract, retain, and develop top talent, and build teams to ensure organizational effectiveness, transparency, and communication
Required Minimum Education:
- Medical Degree or equivalent
Required Years of Related Experience:
- Physician (MD or equivalent) with 8 or more years of substantial Pharmaceutical Industry experience; clinical experience highly 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
- Knowledge of cellular therapy products and the associated PV guidelines and global regulatory framework
- Demonstrated in-depth knowledge of principles of cellular therapy product development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of risks and benefits, and safety assessment of cellular therapy compounds 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 (e.g., 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
- Familiarity using AI-assisted tools (e.g., large language models, Co-Pilot, code/ content assistants) to increase productivity while applying good judgment and data privacy practices.
- Working knowledge of the use of Microsoft suite of software products including Excel, Power Point, and Word
Required Skills:
Preferred Skills:
Clinical Operations, Compliance Management, Compliance Risk, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing