Executive Director, CMC Development

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, but few options.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

_

• Lead the strategic transformation of the CMC department (both early and late-stage groups), driving innovation and developing forward-looking strategies for the development and commercialization of next-generation products

• Develops an integrated CMC strategy considering value drivers incl. patient convenience to deliver differentiated pharmaceutical product presentations. Supports and implements corporate and divisional initiatives and strategies

• Responsible for the Quality / Module 3 content of global filings and high-quality CMC dossiers, global approvals and commercialization of products. Key member of teams that participate in communication and meetings with global Health Authorities along the development continuum

• Represents all CMC areas, serving as spokesperson for the CMC project teams and ensures information flow across the R&D and all line functions. Ensures high quality science, appropriate technology solutions and exceptional inclusive and collaborative team performance are leveraged to drive compliance with global regulatory and quality requirements

• Critically evaluates and integrates drug substance, drug product, control strategy and device inputs to an overarching CMC strategy and plan that aligns with corporate business objectives. Decision-making will often require assessment and integration of drug-like properties, formulation science, engineering, analytical, and device technical information in conjunction with the overall program strategy, with full consideration of current regulatory and compliance requirements

• Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieves efficiency with respect to time, and budget. Serves as a mentor for functional representatives, provides feedback and input to their functional managers and identify growth needs for team members

• Reviews contracts with Third Party Manufacturers and consultants. Develops a budget in collaboration with R&D senior leadership, obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness

• Oversees CMC development teams for assigned projects: develops meeting agendas, apprises risks and mitigation plans with CMC management, conduct periodic reviews, to ensure that phase transition criteria are met in the most effective and resource sparing manner. Drives accountability and urgency and overall team performance and output

• Leverage extensive experience to make a significant impact across the entire pharmaceutical, biotech, and delivery device value chains. This includes contributions across discovery, development, product registration, and life-cycle management for all drug modalities

• Leads early-stage and late-stage projects in one or more modality areas (NBE, NCE, gene/cell therapy) using a matrixed team approach

• Build influential relationships across R&D, Quality, Regulatory, Clinical and Commercial Manufacturing organizations; demonstrating the ability to apply critical thinking skills to identify areas for process improvements

• Solve complex problems and remove barriers, providing focus to teams and enabling the agile and speedy delivery of the portfolio

• Promotes scientific and entrepreneurial thinking, encourages creativity, and drives quality and results with respect to science, time, budget and resources. Mentors junior colleagues. May have direct reports

• Ensures compliance with regulatory, health, safety and environmental requirements. Is always informed of trends and breakthrough developments in the global technical, regulatory and compliance arena and industry practices

• Other duties as assigned

• BS/BA degree in Chemical Sciences, Pharmaceutical Sciences or related field and 20+ years of pharmaceutical industry experience in multiple functions/organizations leading CMC chemical and drug product development for all drug modalities to advance Neurocrine pipeline from discovery to commercialization OR

• Master's degree in Chemical Sciences, Pharmaceutical Sciences or related field and 17+ years of similar experience noted above OR

• PhD in Chemical Sciences, Pharmaceutical Sciences or related field and 15+ years of similar experience noted above

• Extensive previous leadership experiences also required

• Acts as a "trusted advisor" across the company and may be recognized as an external expert

• Provides strategy, vision and direction regarding issues that may have company-wide impact

• Requires in-depth knowledge of the functional area, business strategies, and the company's goals

• Possesses industry-leading knowledge

• Must be self-motivated, detail-oriented, decisive

• Ability to quickly learn and think independently

• Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company

• Excellent managerial skills and experience fostering career development of direct and indirect reports

• Demonstrated ability to influence and lead others.

• Ability to work with a team of individuals to meet organizational goals

• In-depth industry knowledge in the development, implementation, and manufacturing of multiple modalities of GMP pharmaceutical drug substances and drug products for clinical trial use

• Extensive knowledge of diverse dosage forms, encompassing oral and parenteral dosage forms

• Experience developing devices for use in clinical trials and commercialization

• Technical depth and breadth across small molecule, biotechnology/large molecule and delivery devices to successfully progress compounds from discovery through clinical development to commercialization

• Proven expertise in resource planning, consistently achieving research and development goals with safety, quality, output, and cost

• Demonstrated ability to optimize enterprise resources internally and externally and with CROs and CDMOs ensuring seamless coordination

• Commitment to continuous process improvement, driving efficiencies in all areas of operation

• Strong track record of developing and investing in new technologies and capabilities at the enterprise level

• Skilled in creating a culture of innovation

• Demonstrate a proven track record in identifying and developing diverse talents within the organization, while simultaneously building new capabilities to strengthen the R&D organization

#LI-DM1

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.

_