Associate Director, Clinical Supply Chain

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability. About the Role:Supports development and execution of a strategic operating plan for department wide Clinical Supply Chain design/packaging/labeling/distribution activities. Supports production, resource planning and process management to meet portfolio goals, timelines and costs in support of an expanding clinical portfolio for both large and small molecule assets. Leads in the development of company and department policies and procedures impacting overall operations, working towards efficiency and high quality GMP deliverables. Manages a subset of the Clinical Supply Chain Department, mentoring and developing staff at all levels.

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Your Contributions (include, but are not limited to):

• Lead and implement complex clinical packaging strategies aligned with portfolio delivery and Clinical Operations forecasts

• Execute large, international, cross-functional Clincal Supply Chain activities including collaboration with Clinical Operations to forecast drug product, budget requirements, planning, kit/label specifications, IXRS and distribution logistics

• Execute GMP clinical packaging outsourcing strategy with experience in large and small molecule assets

• Experience working with Pre Filled Syringes and Auto Injector presentations

• Manage GMP vendor relationships, supporting selection of highly qualified third-party vendors

• Responsible for packaging configuration and design to support clinical protocols

• Review and approve packaging documentation as appropriate

• Provide leadership within the team on a day-to-day basis. Creates vision and goals to drive change and efficiency

• Support annual budgeting, contracting, scheduling, packaging, labeling and coordination of any testing required at CMO sites

• Develop proactive relationships with key business leaders ensuring entire team provides superior customer service

• Integrate and improve processes, systems, policies and procedures

• Recommend department strategies and policies. Ensures that all SOPs are followed for performing required tasks per cGMP standards and to Neurocrine expectations

• Review and approve distribution requirements, establishing distribution plans and contracts with appropriate parties

• Represent Clinical Trial Materials in project and clinical team meetings informing CMC leaders as well stakeholders as to progress, resource requirements, barriers/issues needing resolution

• Manage direct reports through education and mentoring, providing an example of innovation and excellence

• Performs other job-related duties as assigned

Requirements:

• BS/BA degree and 10+ years of relevant experience, OR

• Masters and 8+ years of related experience, OR

• Drives strategic implementation of efficient solutions on highly complex Clinical Supply Chains

• Requires expertise in international Clinical packaging and distribution knowledge for both large and small molecule assets

• Requires effective communication with technical personnel both internally and externally

• Must demonstrate capabilities in all aspects of clinical packaging activities, project management, planning, budgeting, resource allocation, supervising employees, team leadership, managing third party vendors and timely goal achievement

• Must be grounded in the fundamentals of pharmaceutical development and understand all phases of clinical development (Phase 1 - Phase 4).and have advanced technical knowledge within these areas

• Extensive knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives including the role of the Qualified Person (QP)

• Skillful in collaborative platforms (e.g., SharePoint, MS Teams, Zoom), Electronic Data Capture systems, and Inventory Management systems

• Demonstrate professional 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

• Must have a strong working knowledge of cGMP’s and FDA requirements for IND’s and NDA’s as well as European regulatory requirements for CTR filings for providing input and review

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

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The annual base salary we reasonably expect to pay is $161,100.00-$220,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.