Johnson & Johnson Careers
Sr Scientific Director, Early Therapeutic Area Lead (eTAL) and Strategic Process Lead, Nonclinical safety Neuroscience
Requisition ID: 5604190524
Janssen is actively recruiting for a Sr Scientific Director, Early Therapeutic Area Lead (eTAL) and Strategic Process Lead, Nonclinical safety Neuroscience, to be located in La Jolla, CA.
The Senior Scientific Director, Early Therapeutic Area Lead (eTAL) and eTAL Strategic Process Lead, Nonclinical Safety (NCS) is a scientific leader assigned specifically to the Neuroscience 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 also serve as a “captain” or matrix leader to pull other eTALs together and to establish process for early target liability assessments and target safety evaluation
- Accountable as NCS eTAL for managing and coaching (leading with/without authority) NCS leads who work in the neuroscience therapeutic area space, this includes reviewing and providing expert advice on toxplans, study proposals, outputs, regulatory submission review and prep.
- Accountable as the primary NCS representative in portfolio governance stage-gate or other review forums, and provides coaching/reviewing/providing recommendations for diligence in the neuroscience therapeutic area space, includes interface with stakeholders outside of NCS
- Sets strategy for all TA’s regarding early target evaluation (expression and liabilities).
- May directly manage small team on these capabilities. 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 expert 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 contributing to the 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.
- A minimum of BS in biological science
- A PhD OR an MS with more than 20 years’ experience is preferred.
- It is preferred that the successful candidate has a degree in one of the following areas: Toxicology, Pharmacology in neuroscience arena, Pharmaceutic science, Cell Biology, Pathology, or Chemistry/biochemistry
- A minimum of 15 years of experience is required
- Knowledge of pharmaceutical science, drug development of multiple modalities, therapeutic area science and toxicology strategies is required
- Knowledge of Regulatory requirements/expectations for first in human approval or registration of pharmaceutics/biologics is required
- 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.
- Experience in biologics and small molecule development is preferred
- Cross-site team leadership and experience working with international teams is preferred
- Experience in leading laboratory-based teams that support pharmacology, pathology or predictive safety is preferred
- Excellence in presentation to senior leaders is preferred
United States-California-San Diego-
Janssen Research & Development, LLC. (6084)