Distinguished Scientist. Nonclinical Safety Leader

Johnson & Johnson Innovative Medicine•Cambridge, MA

10d•$164,000 - $282,900•Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting a Distinguished Scientist, Nonclinical Safety Leader within Preclinical Sciences and Translational Safety (PSTS). This hybrid position can be based in Spring House, Pennsylvania, or Cambridge, Massachusetts. The role provides toxicology leadership across discovery and development projects in a large, varied portfolio spanning multiple therapeutic areas and innovative modalities. The leader collaborates with discovery scientists to identify and nominate candidate molecules and with development teams to advance molecules into human trials and through global registration. The position leads nonclinical safety and pharmacokinetic project teams, represents nonclinical safety on global project teams, and provides strategic, scientific, and matrix leadership to support data-driven decisions. The role also includes risk assessment and mitigation, interpretation of toxicology and safety pharmacology data, regulatory document preparation and health authority responses, medical safety contributions, due diligence, collaboration with CMC, external scientific engagement, mentorship, and leadership of strategic initiatives. Future-facing people leadership responsibilities may arise as needed.

Requirements

A minimum of a Master’s degree in Toxicology, Pharmacology, or a related discipline.
At least 15 years of relevant pharmaceutical or biotechnology industry experience with a Master’s degree, or at least 10 years with a doctoral-level degree.
Proven experience representing toxicology or nonclinical safety on multidisciplinary project teams.
Strong understanding of the drug discovery and development process.
Excellent oral and written communication skills.
Ability to collaborate with all levels in a cross-functional team environment.

Nice To Haves

Doctoral degree (PhD, DVM, MD, or equivalent) in Toxicology, Pharmacology, or a related discipline.
Experience conducting due diligence activities.
Previous experience as a Study Director or Study Monitor under Good Laboratory Practice (GLP) regulations.
Familiarity with diverse and emerging or specialized therapeutic modalities.
Board certification, such as Diplomate of the American Board of Toxicology (DABT).

Responsibilities

Lead PSTS project teams of nonclinical safety and pharmacokinetic (PK) scientists, ensuring effective information transfer and interfacing with senior management.
Represent nonclinical safety on global project teams and provide strategic leadership, toxicology expertise, and matrix leadership to support high-quality, data-driven portfolio decisions.
Create target risk assessments and plans to screen for and mitigate potential risks.
Analyze toxicology and safety pharmacology studies, contextualize findings for human safety, and prepare nonclinical safety assessments.
Contribute to issue-resolution teams by generating hypotheses and investigative strategies.
Be accountable for global regulatory nonclinical documents and health authority responses supporting clinical trials and compound registrations.
Participate in medical safety teams, signal detection analyses, and risk mitigation strategies.
Conduct nonclinical safety risk assessments for due diligence of potential licensing and acquisition opportunities.
Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality.
Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities.
Maintain scientific depth and knowledge of competitive intelligence and regulatory landscapes for assigned projects.
Communicate effectively with stakeholders, including regulatory authorities, using drug development experience.
Provide leadership and mentorship within the PSTS organization.
Lead strategic initiatives as required.

Benefits

Eligibility to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the company’s long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for certain state residents.
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, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 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.