Sr. Specialist, R&D Strategic Ops

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.

_

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

• Coordinates, aligns, and monitors research and development activities for program-specific cross-functional plans and risks

• Coordinates project timelines to support R&D goals from both a technical and business operations perspective

• Supports outsourced development and clinical/commercial manufacturing activities, as it relates to business, contract, financial management, and/or operational efficiencies

• Manages the operational activities (schedule, timelines, cost) of the vendors, ensuring cost, quality, metrics, delivery and program objectives are met. Manages operational risk at the vendors

• Assists in CDMO site evaluation/selection, preparation of the request for proposal (RfP) and contracting process

• Partners with key stakeholders in the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements; provides guidance on drafting documents and works with legal to ensure documents are processed in a timely manner

• As member of R&D contract management center of excellence, participates in design, tracking and operational excellence for R&D contract management activities, enters contract information into the system, collaborates with contract owners and Legal to communicate with external vendors for questions & clarification, and oversees completion of the contracting process in a timely manner

• Facilitate communications between key science and management stakeholders, as needed

• Collaborates with multiple functional lines (R&D, Regulatory, Quality Assurance, Clinical, Legal, Finance) within the company

• Facilitates and schedules meetings with internal personnel, as needed, to ensure cross-functional participation on the project teams

• Collaborates with (may lead) internal cross-functional teams and vendors to determine development, clinical, and commercial manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended

• 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

• Partners with Neurocrine Quality Assurance to ensure vendors are in compliance with all cGLP/cGMP guidelines and Neurocrine SOP requirements

• Tracks spend and plans resource allocation at contract vendors

• Supports in providing monthly/quarterly accruals to Accounting/Finance

• Supports in high-level management of department’s annual budgeting process and Capex spend on equipment purchase

• Other duties as assigned

Requirements:

• BS/BA degree in Chemistry, Biochemistry or related discipline and

  4+ years of Pharmaceutical industry experience MS/MA degree in Chemistry, Biochemistry or related discipline and 2+ years of similar experience as noted above

• PhD in Chemistry, Biochemistry or related discipline and some relevant experience; may include postdoc experience

• Hands-on experience executing and interpreting pharmaceutical analysis, and drug product unit operation processing is preferred

• Demonstrates solid level of understanding project / group goals and methods

• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes

• Able to explain the process behind the data and implications of the results

• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline

• Strong knowledge of scientific principles, methods and techniques

• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools

• Ability to work as part of a team; may train lower levels

• Excellent computer skills

• Strong communications, problem-solving, analytical thinking skills

• Detail oriented yet can see broader picture of scientific impact on team

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Strong project management skills

• Strong understanding of cGLPs and cGMPs relating to pharmaceuticals

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

• Ability to learn quickly and think independently

• Exhibit strong scientific and business acumen

• Demonstrated understanding of chemical and instrumental methods for analyses of development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials

#LI-OB1

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.

_

The annual base salary we reasonably expect to pay is $101,200.00-$146,550.00. 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 20% 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.