Director, Clinical Translational Safety Lead

Johnson & Johnson Innovative Medicine•San Diego, CA

1d•Onsite

About The Position

As a Clinical Translational Safety Lead within the Preclinical Sciences and Translational Safety team (PSTS), you will guide the strategy for mechanistic derisking and understanding of safety signals in pre-clinical and clinical development across a multi-modality portfolio in therapeutic areas like oncology, immunology, neurosciences, and ophthalmology. This individual contributor role is part of the Translational Safety leadership team, reporting to the Executive Director, Global Translational Safety. It requires a physician scientist with an investigative mind, strong communication, and collaboration skills in complex, matrixed environments. A deep understanding of systems and pathway biology, mechanistic pathobiology, and biochemistry is essential to translate pathologic and clinical findings into disease phenotypes. The role involves building partnerships with Translational Research, Global Medical Safety, and Clinical Pharmacology, and collaborating with investigative toxicology, pathobiology, safety pharmacology, and other pre-clinical sciences to set investigative pre-clinical strategy and bridge knowledge between pre-clinical and clinical disciplines. You will also contribute to discovery programs by interpreting competitive intelligence on clinical safety data and establishing a robust translational safety assessment framework to integrate clinical insights back into discovery, optimizing preclinical safety models and improving future therapies' safety profiles.

Requirements

Medical education (MD) and advanced degree (PhD, MS) in investigative medical sciences such pathology, radiology, nephrology, internal medicine, oncology, rheumatology, or similar.
Deep understanding of systems and pathway biology, and ability to translate pathologic and laboratory findings into disease phenotypes and actionable follow up experiments or mitigation strategies.
5+ years of experience in clinical research, medical safety, medical affairs, translational research, investigative toxicology, or related roles within the area of drug discovery and development.
Excellent analytical and critical thinking skills, with a focus on innovative approaches to mechanistic approaches and reverse translation in safety science.
Able to communicate effectively and with confidence to senior management and R&D leaders.
Clinical Operations
Clinical Research and Regulations
Clinical Trials
Collaborating
Data Governance
Data Management and Informatics
Developing Others
Drug Discovery Development
Global Market
Inclusive Leadership
Industry Analysis
Innovation
Leadership
Market Research
Program Management
Research Ethics
Scientific Evaluation
Scientific Research
Stakeholder Management

Nice To Haves

Phase I clinical trial and clinical PoC experience preferred.
Experience in a broad range of therapeutic modalities is a plus.

Responsibilities

Develop and maintain strong collaborative partnerships with key stakeholders including Global Medical Safety, Clinical Development, Medical Affairs, Translational Research and other related functions to formulate investigative and mechanistic frameworks to understand safety signals arising in our clinical programs.
Serve/Act as a key point of contact for PSTS on the initiative of creating “a translational safety community of practice” between Global Medical Safety and PSTS.
Provide expert consultation on translational safety issues and evaluate safety packages in competitive intelligence assessments for target or modality de-risking
Contribute expertise to support development of advanced in vitro models (3D, organoids, micro physiologic systems) and integrated AI/ML foundational models as we invest in R&D innovation in collaboration with laboratory experts and in silico modelers
Translate pathologic findings and biochemical/genetic pathways into disease phenotypes to enhance our understanding of data generated in the pre-clinical studies and to help contextualize risks and mitigation strategies in our first-in-human studies
Lead efforts to integrate clinical safety data back into preclinical models (reverse translation), improving predictive accuracy and addressing potential safety risks early in development.
Provide mentorship toward our PSTS goal to develop future, outstanding preclinical science experts and through creating and upholding a culture of engagement, scientific rigor, inclusion, program impact and innovation

Benefits

annual performance bonus
medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
Company’s consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
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