Who We Are:
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.
What We Do:
Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (in collaboration with AbbVie*)
About the Role:
Responsible for supporting and coordinating consistent and streamlined business and operations activities for all areas of R&D, including Research, Preclinical, and CMC Development, for efficient and effective execution of Neurocrine's pipeline strategy. Support includes strategic planning, project coordination, budgeting and finance, laboratory and facility operations, contract management, vendor management, training and development, compliance and safety, and systems and business tools. May also serve as Therapeutic Area and/or CMC program managers from discovery through to commercial phase assets, agnostic to modality (small molecule, peptides, biologics, gene therapy, antibodies, etc) and facilitate communications between stakeholders to drive cross-functional collaboration and execution.
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Your Contributions (include, but are not limited to):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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The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. 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.
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