Associate Director, Non -Clinical Outsourcing

Job Description

Who We Are

Nonclinical Drug Safety (NDS) empowers groundbreaking discovery research through advanced in-silico, in-vitro, and in-vivo models that influence the selection, development, and marketing of safe therapeutics. We maximize the safety attributes of drug candidates and inform our clinical partners through insightful non-clinical safety assessments. Our approach, rooted in regulatory toxicology, novel models, unique de-risking strategies, and innovative problem-solving, is designed to support informed decision-making and ultimately deliver the most accurate product labels.

Position Overview

NDS is seeking an Associate Director of Nonclinical Outsourcing to lead the sourcing of nonclinical studies and associated activities by collaborating with internal colleagues and our contract research organizations (CROs) to provide initial study designs, obtain project estimates, assist with the development of study protocols, assist Study Monitors with the logistical components of all nonclinical studies, and ensure alignment with internal development team timelines.

The role supports programs from early discovery through development across therapeutic modalities, enabling nonclinical data that informs key decisions and regulatory submissions.

Key Responsibilities

• Lead the sourcing of nonclinical safety studies (GLP and non-GLP) for inclusion in regulatory submissions that support clinical development and/or marketing authorization.
• Interact directly with external client service representatives, management and other key personnel (e.g., Study Directors) at multiple CROs for study coordination, planning of initial protocol development, coordinating study report review, and defining project study timelines.
• Partner with Study Monitors and internal functional group experts to facilitate the planning, development, tracking, and reporting timelines of nonclinical outsourced studies
• Participate in selection of CROs, including qualification/scientific assessments and the tracking of vendor performance.
• Monitor CRO performance and drive consistency in processes, quality, and communication
• Partner with internal stakeholders, our Research & Manufacturing division, Finance, and NDS leadership to develop, track, and forecast our sourcing budget, ensuring alignment with NDS priorities, accurate financial planning, and proactive identification of risks and variances.
• Oversee operational readiness for study initiation, including contracts, materials, and documentation.
• Maintain timely, accurate tracking of studies and provide clear status updates to internal stakeholders on externally outsourced work.
• Identify and implement process improvements to enhance sourcing efficiency and quality.

- Qualifications

Education
:

• Bachelor's degree in biology, toxicology, animal sciences, pharmacology, pharmaceutical sciences, chemistry, biochemistry, biomedical sciences, or related field with 8+ years of relevant experience in the biotechnology/pharmaceutical industry or contract research organization.

Required Skills:

• Knowledge of global regulatory guidelines (e.g., ICH, GLP, SEND).
• Strong attention to detail, with the ability to critically evaluate study-related documentation and correspondence.
• Outstanding communicator responsible for conveying key messages to internal stakeholders and external vendors.
• Knowledge of nonclinical safety study designs.
• Demonstrated organizational and multi-tasking skills and effective time/program management.
• Ability to navigate and be successful in a fast-paced, highly-matrixed and program team-driven environment with frequent course corrections and changing deliverables and timelines.

Preferred

Skills:

• Advanced degree (MS, PhD, or equivalent)
• Direct experience working with CROs, including vendor selection and performance management.
• Previous experience conducting nonclinical safety studies.
• Experience with budgeting, contracting, or financial tracking.

Required Skills:
Adaptability, Budget Development, Decision Making, Drug Development, Innovative Solutions, Knowledge Management, Non Clinical Research, Project Management Tools, Project Planning, Regulatory Compliance, Risk Management, Root Cause Analysis (RCA), Schedule Management, Strategic Planning

Preferred

Skills:



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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

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