Johnson & Johnson Careers
Sr. Scientific Director - Nonclinical Sciences, Early Therapeutic Area Lead (eTAL), Immunology
San Diego, California
Requisition ID: 5627190524
The Senior Scientific Director, Early Therapeutic Area Lead (eTAL) Immunology, Nonclinical Safety (NCS) is a scientific leader assigned specifically to the immunology portfolio and has responsibility for leading projects that cover multiple modalities primarily from the nomination of a target through selection of the new molecular entity (NME) and preparation of the First-In-Human (FIH) submission. The NCS eTAL is the interface between the NCS organization and the leaders in the therapeutic areas (TA).
The eTAL has significant scientific expertise in drug discovery, predictive safety/discovery toxicology, laboratory and pharmacology sciences and has specialized knowledge and passion for the therapeutic area. The eTAL will interact with TA leadership in TA forums and discovery portfolio committee (DPC) governance stage gate forums, and, may also serve as the NCS lead or lead delegate as needed (e.g. FIH stage gate). The eTAL is accountable for recommendations for diligence as assigned, and for strategic planning for drug discovery and NME selection paradigms, in partnership with specific NCS laboratory functional leaders.
The eTAL will serve as a coach and mentor for NCS Leads working in their portfolio including providing expert advice and review of target liability assessments and de-risking plans, pre-NME candidate de-selection/selection plans, non-GLP protocols, participation or host for “mock review” forums prior to NME selection and FIH stage gates with the purpose of assuring scientific and regulatory questions are proactively addressed.
The eTAL is expected to maintain scientific depth and expert working knowledge of competitive intelligence and regulatory landscape in TA arena and to tracks milestones, issues, and attrition and should highlight strategic gaps in NCS for action supporting the TA area portfolio. The eTAL may also serve as the NCS lead or lead delegate as needed. The eTAL is a member of the NCS Global Leadership Team and will lead or participate in special strategic projects as needed.
This role will work closely in partnership with the immunology dTAL.
-Serve as NCS eTAL managing/coaching NCS leads who work in the immunology and related therapeutic area space, this includes reviewing and providing advice on toxplans, study proposals, outputs, regulatory submission review and prep.
-Serves as the NCS eTAL and primary NCS participant in portfolio governance stage-gate or other review forums, and provides coaching/reviewing/providing recommendations for diligence in the immunology therapeutic area space, includes interface with stakeholders outside of NCS
-Drives strategic planning for NCS preparedness to operate in the designated therapeutic area space, including NCS playbook content, providing management updates, fostering cross-industry activities and forums with regulators and external experts
-Participates and/or helps to drive general training and advice forums for NCS leads who work on other parts of the Janssen portfolio. As a member of the NCS GLT is generally involved in recruiting and onboarding new staff, and overall NCS operations and strategic planning. Supports and drives research publications and maintains visibility with external academic or industry societies to accelerate and assure we maintain cutting edge capabilities for pre-NME toxicology sciences.
PhD with at least 12 years of experience, or BS or MS with at least 20 years of experience.
Degree in Pharmacology, Pharmaceutic Science, Immunology, Cell Biology, Toxicology, or Chemistry/Biochemistry.
Knowledge of R&D for early target discovery and lead discovery pharmaceutical science, drug development of multiple modalities, and therapeutic area science and toxicology strategies, regulatory requirements/expectations for first in human approval or registration of pharmaceutics/biologics.
Past experience leading a laboratory function is preferred and includes knowledge of cell and pharmacology assays, visualization of diverse data, and biostatistics knowledge.
Strong verbal and written communication, appropriate for executive or high visible external venues.
Experience in effective coaching. Strong organizational skills and team leadership.
United States-California-San Diego-
Janssen Research & Development, LLC. (6084)