Sr Director Product Safety Head - Cellular Therapy, Hematology

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).

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
• Oversee, 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
• 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

Qualifications

• Medical Degree or equivalent
• 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
• 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