Associate Director, Global Nonclinical Submissions Operations

Associate Director, Global Nonclinical Submissions Operations

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Nonclinical Submissions Operations. This position is a hybrid role and will be located in Spring House, PA.

The Associate Director, Global Nonclinical Submissions Operations, within the Preclinical Sciences and Translational Safety (PSTS) organization, will lead the document specialist and SEND (Standardization for Exchange of Nonclinical Data) teams to deliver state-of-the-art submissions aligned with global requirements.

Principal Responsibilities:

• Lead and mentor the nonclinical document specialist and SEND teams, including internal and contracted staff, to meet pipeline goals with timely and high-quality deliverables across all programs and development phases.
• Provide operational support for nonclinical submissions, including planning and management of timelines and resources, knowledge management of procedures and best practices, chair global submissions team meetings with agenda/minutes/action items/follow up monitoring, and generation of KPIs/metrics.
• Implement best practices, drive continuous improvement, and identify efficiencies to enable quickest timelines and engagement in data science initiatives to develop and adopt Artificial Intelligence (AI)/Machine Learning (ML) tools for submissions-related processes.
• Ensure consistent document/SEND support across portfolio and maintain adherence to standard operating procedures and regulatory requirements.
• Collaborate with cross-functional partners across PSTS and Discovery, Product Development and Supply (DPDS) to ensure appropriate readiness for submissions from pre-portfolio to post-registration phases.
• Ensure early identification and timely communication of submissions related issues and develop contingency plans proactively to address issues.

Qualifications:

• A minimum of a Master's degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is required. Advanced degree (PharmD, Ph.D. or equivalent) in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is preferred.
• A minimum of 6 years of relevant experience with submissions supporting diverse modalities, geographies, and therapeutic areas is required.
• A minimum of 3 years of direct people management experience is required.
• Strong knowledge of nonclinical drug development is required.
• Strong knowledge of global submissions requirements is required.
• Strong change/process management experience is required.
• Knowledge of Good Laboratory Practice (GLP) and data security/integrity standards required.
• Must have excellent communication and interpersonal skills.
• Must have strong negotiating, troubleshooting and organizational skills.
• The ability to work effectively in a collaborative environment and to help coach and mentor staff similarly is required.
• This position will require up to 10% domestic and international travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.