Manager, R&D Strategic Operations

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Coordinates, aligns, and monitors research and development activities for program-specific cross-functional plans and risks
• Assist with project execution subteams and tracking, risk management and timelines ( for assets pre-Dev Can through launch) in areas related to CMC, preclinical or Research
• Manages the R&D team to ensure activities for all assigned programs (including life cycle management) are progressing effectively and in alignment with overall organizational goals
• Actively engages with key stakeholders in the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements
• May help with departmental update meetings, dashboards design and organization, and tracking of project progress
• Is a contributing member of the R&D Strategic Operations contracting center of excellence and collaborates closely with Legal and Sourcing to initiate, follow up and generation of contracts
• Collaborates with internal cross-functional teams and CDMOs to determine commercial manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended
• Leads or manages technical sub-teams within R&D scope and ensures communication of strategy, interdependencies and critical path to key stakeholders
• Manage project timelines to support goals from both a technical and business operations perspective when assigned
• Perform technical review of documents where appropriate
• Provide visibility to key stakeholders on all CMO matters, tactical & strategic, and manage stakeholder priorities across all Neurocrine activities at the CMOs
• Establishes operational objectives and work plans, may delegate assignments to subordinates
• When applicable, manage the operational activities (schedule, timelines, cost) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met. Manage operational risk at the CMOs
• When applicable, collaborate with Neurocrine Quality Assurance to ensure CMOs follow all cGMP guidelines and Neurocrine SOP requirements, contribute with Finance for R&D wide budget planning and transparency, works closely with Sourcing and Procurement, Accounts Payable, Legal to support R&D needs
• Help identify or create synergies in spend and resource allocation at the CMOs
• Manages the day-to-day work of less experienced team members when assigned; supports the personal and professional development of RDSO team members, or direct reports if any
• Proactively identifies and champions new process and/or improvements, and solutions to complex issues at the vendors
• Anticipates stakeholder needs and provides visibility to key stakeholders on all vendor matters, tactical & strategic, and manages stakeholder priorities across all Neurocrine activities at the vendors
• Tracks spend and plans resource allocation at contract vendors

Requirements:

• BS/BA degree in Biology, Chemistry, pharmacology or related science and 6+ years of Pharmaceutical industry experience. Hands-on experience executing and interpreting pharmaceutical analysis, and drug product unit operation processing is preferred OR

• Master's degree in Biology, Chemistry, pharmacology or related science and 4+ years of similar experience as noted above OR

• PhD in Biology, Chemistry, pharmacology or related science and 2+ years of similar experience as noted above, some managerial / functional management or lead experience preferred

• 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 and awareness of cross-functional needs

• 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

• Able to work independently and in a team environment

• 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 interpersonal skills including the ability to build successful relationships with internal experts/teams and other stakeholders

• Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact

• Identifies and resolves technical, operational and organizational problems/problems relating to own discipline

• Frequently works cross-functionally as the representative for their area

• Content knowledge or expertise in an ADME, Toxicology or Bioanalytical laboratory, CMC, Research or other technical fields in drug development

• Knowledge, experience and familiarity with drug development, project teams and sub team coordination as well as solid understanding of drug development operations

• Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) or other spreadsheet and project management tools

• Expertise managing biopharmaceutical operations, including contract management, negotiation, budgeting and administration including billing/invoicing, issue resolution, point of contact for vendors

• Ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for preclinical operations

• Ability to read and interpret contracts, ensure contract language / terms meet company standards

• Strong contract administration skills, including budgeting, billing/invoicing, issue resolution, point of contact for CRO

• Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact

• Identifies and resolves technical, operational and organizational problems/problems relating to own discipline

• Understanding of cGMPs relating to early drug product manufacturing

• Must be self-motivated, detail-oriented, possess familiarity of physical & analytical techniques as they pertain to biopharmaceutical properties

• Demonstrated ability to learn quickly and think independently

• Exhibits strong scientific and business acumen

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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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