Head of Translational Safety

Johnson & Johnson•Titusville, NJ

15d

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com 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, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Johnson & Johnson is recruiting for a Head of Translational Safety to be located in Spring House, PA, Horsham, PA, Titusville, NJ or Raritan, NJ. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine The primary responsibility of the position is to develop Translational Safety (TS) capabilities in Global Medical Safety in collaboration with Preclinical Sciences and Translational Safety (PSTS) and other relevant functions. The position holder is responsible for designing and delivering innovative translational safety strategies for drug discovery and clinical development programs across J&J IM portfolio throughout the life cycle and across all Therapeutic Areas (TA). They will contribute TS aspects to signal evaluation, regulatory submissions, and HA interactions and responses, through partnership with Therapeutic Area Safety Heads, Medical Safety Officers and clinical development stakeholders and PSTS Safety Leads. The position holder will facilitate seamless, two-way flow of data and other relevant information between non-clinical and clinical functions, lead or contribute to the Identification and development of sensitive and specific safety biomarkers for use in non-clinical and clinical spaces, bring innovative approaches to predict safety issues, elucidate mechanism of injury, identify appropriate risk assessment and management approaches and deliver safe and effective therapies to patients. They will represent Global Medical Safety for translational safety perspectives in relevant cross-functional project and strategy teams and contribute or lead application of artificial intelligence and technology to translational safety activities While at first there will not be any direct reports, the position holder will be expected to build and lead a team of physicians and / or scientists working on translational safety activities.

Requirements

MD or PhD required; MD/PhD preferred
At least 10 years of experience in drug development in a pharmaceutical industry or academic setting
Expertise and experience in translational medicine / safety
Track record of success in leading innovative initiatives, developing strategy and execution of deliverables
Familiarity or expertise in technology and artificial intelligence
Excellent English verbal and communications skills
People leadership experience preferred
Ability to collaborate with other functions and work as a team
Ability to interact effectively across boundaries using influencing and relationship building skills
Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals

Responsibilities

Develop translational safety capabilities in Global Medical Safety in collaboration with non-clinical safety and other relevant functions and design and deliver innovative translational safety strategy for clinical development programs across Johnson and Johnson Innovative Medicine portfolio.
Support signal and risk evaluation through translational safety contributions throughout the life cycle of the products across all therapeutic areas and contribute to regulatory submissions, health authority interactions and responses.
Lead or contribute to the Identification and development of sensitive and specific safety biomarkers for use in non-clinical and clinical spaces
Bring innovative approaches to predict safety issues, elucidate mechanism of injury, identify appropriate risk assessment and management approaches and deliver safe and effective therapies to patients.
Member of the Global Safety Strategy and Risk Management Senior Leadership Team and contributor to Portfolio Review, Safety Oversight, First in Human Early Development Committee and Development Committee forums.
Partner with Therapeutic Areas Safety Heads, Medical Safety Officers and clinical development stakeholders and collaborate with Preclinical Sciences and Translational Safety (PSTS) Safety Leads.
Facilitate seamless, two-way flow of data and other relevant information between non-clinical and clinical functions
Represent Global Medical Safety for translational safety perspectives in relevant cross-functional project and strategy teams
Communicate regularly and prepare and make presentations within the department, to internal governance committees and external (to J&J) forums as required

Benefits

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

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