Director, Clinical Translational Safety Lead

Director, Clinical Translational Safety Lead

In addition to the US based locations, this role can also be based in Belgium, which is linked to R-071725 Clinical Translational Safety Lead.

Job Summary

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.

What's in it for you

If you have a creative scientific, translational and strategic mindset and you thrive on (1) identifying opportunities for (cross disciplinary) project impact, (2) raising the scientific bar of our discipline and (3) challenging/defending scientific and/or strategic project views to senior management and senior governance bodies, this will be an excellent opportunity to (1) further grow you career, (2) significantly impact drug discovery and development and (3) ultimately to help patients.

In addition, our R&D culture of being courageous in science and unwavering in execution and of being one team that CARES for each other enables us to navigate uncertainty, seize opportunities, and lead where medicine is going.

Key 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

Some Key Qualifications

• 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.

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is: $199,000-$343,275