Head of Translational Safety

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 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 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

Education Required:

• MD or PhD required; MD/PhD preferred

Requirements:

• 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

The anticipated base pay range for this position is $232000 to $401350.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Companys 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

• Additional information can be found via the following link: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

  Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

  Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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  Required Skills:

  Preferred Skills:

  Clinical Operations Compliance Management Developing Others Inclusive Leadership Industry Analysis Leadership Medicines and Device Development and Regulation Mentorship Presentation Design Quality Control (QC) Research Ethics Risk Compliance Risk Management Safety Investigations Safety-Oriented Serious Adverse Event Reporting Standard Operating Procedure (SOP) Technical Writing