Neurocrine Biosciences · 7 hours ago
Clinical Supply Chain Manager
San Diego, CA
Full-time
Onsite
Senior Level
$131K/yr - $179K/yr
6+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering life-changing treatments for patients. The Clinical Supply Chain Manager will support activities related to Clinical Trial Material, managing complex studies and collaborating with various teams to ensure compliance and efficient supply logistics.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead CTM supply chain activities starting with collaborating with Clinical Operations to forecast all required products per clinical study including Investigational Products (IP), ancillary components and comparators/background medications that are required
Plan and design packaging configurations to support clinical protocols as needed
Review and approve all required documentation for CTM packaging. This will include label generation, translations management, component specifications, bottling, blistering, kitting at a minimum. Work collaboratively with internal departments to produce products meeting appropriate requirements
Establish distribution requirements and set up distribution plans and contracts with appropriate parties
Establish IRT requirement and manage CTM supply within the IRT throughout a clinical study
Manage vendors, including to identify, evaluate and ensure outsourced vendors have the required expertise, capabilities and quality/compliance standards to support drug product manufacturing, packaging, labeling, distribution, storage and destruction processes
Create, review and approve all required documentation for engaging CMOs, including budget review, contract review, scheduling, manufacturing, packaging, labeling & testing of drug products at CMO sites
Develop and support all SOPs required to perform required tasks per cGMP standards and Neurocrine expectations
As a project member or leader, may represent Pharmaceutical Operations in Company-CMO project team meetings. Inform Pharmaceutical Operations leaders as well stakeholders as to progress, resource requirements, barriers/issues needing resolution and timelines
Provide operational support services to the CMC Development and Commercial Supply Chain/Manufacturing functions to include management of Stability Packaging operations
Other duties as assigned
Qualification
Required
BS/BA degree in supply chain, operations management or science-related field AND 8+ years of clinical supply chain management experience; Experience IRT/IXRS/IWVR required
Experienced in building and managing forecasts for clinical supply chains
Experience with cGMPs, GCPs, and other regulatory requirements
Good knowledge of formulation and manufacture of small molecules for use in the pharmaceutical industry
Must have demonstrated capabilities in Drug Product Manufacturing activities, project management, planning, budgeting, managing third party vendors and timely goal achievement
Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
Proficiency in collaborative platforms (e.g., SharePoint, MS Teams, Zoom), Electronic Data Capture systems, and Inventory Management systems
Strong working knowledge of FDA clinical trial material requirements for IND's and NDA's as well as European regulatory requirements for dossier filing input and review
Strong understanding of distribution practices including cold chain
Understand managing blinded clinical studies and what is required to protect that blind
Grounded in the fundamentals of pharmaceutical development with advanced packaging and labeling technical knowledge along with an understanding of Regulatory, Manufacturing and Analytical interactions and requirements
Must have demonstrated strong capabilities in project management across multiple projects with a full understanding of packaging, labeling and distribution requirements
Must have Clinical Protocol interpretation background to support demand forecasting
Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
Developing reputation inside the company as it relates to area of expertise
Ability to work as part of and lead multiple teams
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills, with proficiency in Microsoft applications
Excellent communications, problem-solving, analytical thinking skills
Sees broader picture, impact on multiple departments/divisions
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management skills
Effective communication with technical personnel both internally and externally
Ability to establish and meet multiple concurrent priorities and deadlines
Preferred
Master's in supply chain, operations management or science-related field preferred AND 6+ years of similar experience noted above
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
2026-01-06
Company data provided by crunchbase