Head of Translational Safety

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.

Duties and responsibilities include, but are not limited to the following:

• 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 Translat