The Therapeutic Area (TA) Safety Head, Johnson and Johnson Innovative Medicine (J&J IM), 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 Cardiopulmonary (CP) Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM) in Global Medical Safety (GMS)

• 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 J&J IM 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
• Shape the safety strategy and risk management for all J&J IM products during drug development and post-marketing within CP TA

Partner closely and effectively with the TA, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) J&J IM, the Qualified Person for Pharmacovigilance (QPPV) and other J&J IM 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 J&J IM for the implementation and compliance of post-marketing risk management commitments
• Provide oversight, medical expertise and leadership to the TA 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
• 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 J&J IM 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 of pharmaceutical medicines
• 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 where relevant

*Education and Experience:**

• 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
• Proven track record in dealing with difficult safety issues, clinical safety data, interactions with global regulatory departments / agencies, and strong collaborative and networking skills
• 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
• 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

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 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

• The anticipated base pay range for this position is $226,000 to $391,000
• The Company maintains highly competitive, performance-based compensation programs
• Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan
• The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year
• Bonuses are awarded at the Company’s discretion on an individual basis

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
• This position is eligible to participate in the Company’s long-term incentive program
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market