Johnson & Johnson Careers
Sr. Scientific Director, Development Immunology Therapeutic Area Lead, Nonclinical Safety
Spring House, Pennsylvania; La Jolla, California
Requisition ID: 4988190917
The Senior Scientific Director, Development Therapeutic Area Lead (dTAL), Immunology, Nonclinical safety (NCS) is a scientific leader assigned specifically to the Immunology therapeutic area and has responsibility for projects that cover multiple modalities primarily from the preparation for first-in-human trials through post-registration and lifecycle management work. The NCS dTAL is the interface between the NCS organization and the leaders in the therapeutic areas (TA).
The dTAL has significant scientific expertise in drug development, regulatory sciences, and has specialized knowledge and passion for the therapeutic area.
The dTAL will interact with TA leadership in TA forums and development stage gate forums, and, as needed to stand in as delegate for NCS Global Head (e.g. FIH stage gate). The dTAL is accountable for recommendations for diligence (including review and coaching of NCS diligence point person), and for strategic planning in partnership with specific NCS laboratory functional leaders and external CRO partners.
The dTAL will serve as a coach and mentor for NCS Leads working in their portfolio including providing expert advice and review of development toxplans, protocols, regulatory submissions at assigned stages; host “mock review” forums prior to FIH, EOP2, Ph3 (readiness to file) stage gates with the purpose of assuring scientific and regulatory questions are proactively addressed.
The dTAL 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 for TA area.
The dTAL may also serve as the NCS lead or lead delegate as needed. The dTAL sits as a member of the NCS global leadership team and will lead or participate in special strategic projects as needed.
Serve as NCS dTAL matrix-managing/coaching NCS leads who work in the designated therapeutic area, this includes reviewing and providing expert scientific advice on toxplans, study proposals, outputs, regulatory submission review and prep.
Serves as the NCS dTAL and primary NCS participant in portfolio governance stage-gate or other review forums, and provides coaching/reviewing/providing recommendations for diligence in the designated 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.
• Knowledge of pharmaceutical science, drug development of multiple modalities, and immunology therapeutic area expertise
• Experience developing science and toxicology strategies
• Knowledge of regulatory requirements/expectations for first in human approval or registration of pharmaceutics/biologics.
• Strong verbal and written communication, appropriate for executive or high visible external venues.
• Experience in effective coaching.
• Strong organizational skills and team leadership.
• Maintain strong external visibility to assure strong external reputation for NCS.
• Certification in toxicology
• Education: PhD Preferred (minimum of Bachelors degree is required).
• Veterinary or medical school or pathology (MD, DVM, DABT or DACVP)
• Experience with development of molecules through M3 and S6.
• Experience in dealing with FDA or other regulatory interactions and practice in working with clinicians.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-
North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)