Director, Clinical Translational Safety Lead

Johnson & Johnson•San Diego, CA

1d•Hybrid

About The Position

As a Clinical Translational Safety Lead within the Preclinical Sciences and Translational Safety team (PSTS), you will play an important role in guiding the strategy for mechanistic derisking and understanding of safety signals that arise in pre-clinical and clinical development within a robust and multi-modality portfolio covering multiple therapeutic areas (oncology, immunology, neurosciences, ophthalmology, etc). You will be part of the Translational Safety leadership team, working in a global organization of motivated and passionate scientists with expertise in toxicology, safety pharmacology, pathobiology, DMPK and bioanalysis. The individual contributor role (reporting to the Executive Director, Global Translational Safety) requires a well-rounded physician scientist with an investigative mind and a track record of excellent communication and collaboration in cross-functional, complex, and fast-paced, highly matrixed environments. This role requires a deep understanding of systems and pathway biology, mechanistic pathobiology and biochemistry, and the ability to “translate” pathologic and clinical findings into disease phenotypes. The Clinical Translational Safety Lead will build strong partnerships with Translational Research, Global Medical Safety and Clinical Pharmacology and will work in collaboration with key stakeholders in 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 to advance new medicines into the clinic. You will contribute to our discovery programs by providing expert interpretation and contextualization of competitive intelligence around clinical safety data in collaboration with medical safety officers, translational leads and compound development team leaders. This role is responsible for establishing a robust translational safety assessment framework, ensuring that clinical insights are translated back into discovery to inform and optimize our preclinical safety models and ultimately improve the safety profiles of future therapies.

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

Nice To Haves

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

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