Sr. Distinguished Scientist, PSTS, NCS Therapeutic Area Lead for Oncology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Nonclinical Safety

Job Category:

Scientific/Technology

All Job Posting Locations:

La Jolla, California, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is recruiting for a Sr. Distinguished Scientist, PSTS, NCS Therapeutic Area Lead for Oncology located in either Spring House, PA or La Jolla, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  

The Sr. Distinguished Scientist, PSTS, Therapeutic Area Lead (TAL) in nonclinical safety is a senior leadership role that primarily sits in the interface between PSTS and the therapeutic areas and is responsible for leading the nonclinical safety strategy for therapeutic area programs.  This role is assigned specifically to support the Oncology portfolio from candidate selection through post-marketing. The NCS TAL may be a manager but is mainly seen as a scientific leader role with significant “matrix” management responsibility, serving as the coach and mentor for the NCS Leads who work on the projects as assigned in the therapeutic area portfolio.

The TAL role provides expert advice on nonclinical safety across the organization and on potential in-licensing or out-licensing opportunities. Additionally, the predominant role of TAL is to provide coaching and mentorship for NCS Leads working in their portfolio including mandatory advice and review of toxicology plans, protocols with the purpose of assuring scientific and regulatory questions are proactively addressed.

The responsibilities of the TAL include, but are not limited to the following:

• Be an active member of the NCSS Leadership Team.
• Serve as the NCS TAL managing/coaching NCS Leads who work in the Oncology therapeutic area space.  This includes reviewing and providing advice on tox plans, study proposals, outputs, for Immunology projects covering multiple modalities from the nomination of a target through candidate selection.
• Act as the primary NCS participant in portfolio governance stage-gate or other review forums and provides coaching/reviewing/recommendations for diligence in the Oncology therapeutic area space, and includes interface with stakeholders in and outside of PSTS.
• Drive strategic planning for PSTS preparedness to operate in the Oncology therapeutic area space, including NCS playbook content, providing management updates, fostering cross-industry activities and forums with regulators and external experts
• Maintain scientific depth and expert working knowledge of competitive intelligence and regulatory landscape in oncology arena and to track milestones, issues, and attrition while highlighting strategic gaps in PSTS for action. 
• Serve as the PSTS Lead or Lead delegate as needed. 
• Lead or participate in special strategic projects as needed.
• Maintain strong external visibility to assure strong external reputation for PSTS.

Requirements:

• Education: Holds a Doctoral level degree (PhD, DVM, MD or equivalent) or Master of Science (MS) with 20+ years of direct experience, required
  • Experience includes the following:
    • At least 15 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development and demonstrating progressively increasing responsibilities. 
    • Oncology therapeutic area expert.
    • Development of molecules through M3 and S6.
    • Dealing with FDA or other regulatory interactions