Manager, Preclinical Operations

Neurocrine Biosciences • San Diego, CA

2d

About The Position

Responsible for supporting the execution of IND Operations within Preclinical Development. Contributes to cross-functional teams that design and conduct nonclinical studies required to enable First-in-Human (FIH) studies for Neurocrine clinical development candidates. Collaborates with internal stakeholders including Research, CMC, ADME, Toxicology, Regulatory, Biomarker, Project Management, and Clinical to ensure timely progression of development programs. Supports implementation of development strategies, coordinates study activities, and ensures deliverables are completed in alignment with established timelines and quality expectations.

Requirements

• PhD in Pharmacokinetics, Pharmaceutical Sciences, or a related discipline and 1+ years of relevant pharmaceutical/biotech experience OR Master’s degree with 4+ years of relevant experience OR Bachelor’s degree with 6+ years of relevant experience
• Prior experience in preclinical development and IND-enabling activities preferred
• Some project leadership or functional management experience preferred
• Working knowledge of regulatory requirements for IND/CTA submissions
• Familiarity with preparation of regulatory submission components
• Ability to identify risks and support development of mitigation strategies
• Working knowledge of preclinical drug development processes, including Pharmacology, ADME, Toxicology, and CMC components supporting IND-enabling activities
• Ability to analyze issues of moderate complexity and recommend effective solutions within established frameworks
• Demonstrated ability to manage multiple activities or projects simultaneously while maintaining quality and timelines
• Effective collaboration and communication skills in a cross-functional, matrixed environment
• Ability to influence team members and build alignment across functions
• Strong organizational, problem-solving, and project management skills
• Proactive, detail-oriented, and able to adapt to shifting priorities

Responsibilities

• Execute IND-enabling operational plans for assigned development programs in alignment with established strategy and timelines
• Coordinate cross-functional activities required for nonclinical studies and regulatory deliverables (e.g., IND/CTA sections)
• Collaborate with functional representatives to develop study timelines, roles, and responsibilities
• Track progress of studies and deliverables; identify risks and escalate issues as appropriate
• Contribute to the preparation, coordination, and review of regulatory documents (INDs, CTAs, and supporting sections)
• Manage multiple concurrent activities while balancing priorities to ensure timely and high-quality deliverables
• Maintain working knowledge of current regulatory guidance relevant to IND-enabling activities
• May mentor junior staff or lead discrete workstreams within a program
• Perform other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees