Associate Director, Global Nonclinical Submissions Operations

Associate Director, Global Nonclinical Submissions Operations

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 Beerse, Belgium.

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.