Product Safety Head (Sr Director) - Solid Tumors

Johnson & Johnson•Titusville, NJ

21h•Hybrid

About The Position

The Product Safety Head is responsible for safety oversight and strategic direction for multiple products within the Oncology solid tumors 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 portfolio 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 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.

Requirements

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
Serious Adverse Event Reporting
Standard Operating Procedure (SOP)
Tactical Planning

Responsibilities

Oversees end-to-end medical safety strategy of both marketed and developmental phase activities of all the products within the assigned portfolio.
Determines the need for safety risk mitigation measures.
Maximizes efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices.
Implements new approaches to support the scientific evaluation of the safety risk profile product.
Ensures E2E support for complex development plans, regulatory submissions, and post marketing risk minimization requirements across multiple products.
Ensures proactive and timely assessments of safety data.
Understands the emerging and known safety profiles of products within the assigned product.
Prepares aggregate safety reports and responses to Health Authorities (HA).
Communicates potential and known risks to Senior Management, HAs, Prescribers and/or Patients when appropriate.
Ensures consistency of safety strategy execution and communications across multiple products within the assigned product.
Maintains compliance with legal and regulatory requirements.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year