Director, Clinical Development at Neurocrine Biosciences

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Jul, 26

Salary

266000.0

Posted On

26 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical development, Strategic planning, Regulatory affairs, Clinical study design, Biostatistics, Data analysis, Project management, Team leadership, Scientific writing, Drug safety, Regulatory submissions, Clinical operations, Cross-functional collaboration, Budget planning, Personnel forecasting, ICH-GCP

Industry

Biotechnology Research

Description

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 developing strategy and plans for Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety) for our Psychiatry programs. As needed, interfaces with Research and Business Development to assess new product opportunities, develop clinical research strategy and product development plans. _ Your Contributions (include, but are not limited to): Directs Phase 1-3 Clinical Trials for the clinical development in accordance with Neurocrine SOPs and GCP guidance. Develops and implement study protocols consistent with the Development Team direction. Assists in the identification and selection of clinical investigators for clinical trials. Maintains appropriate communication and professional relationship with NBI Clinical Investigators. Conducts assessment and disposition of adverse events (in conjunction with Medical Director if non-physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies. Leads effort within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development Oversees the clinical trials program in conjunction with the Clinical Operations. Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management. Participates on multidisciplinary project teams. Identifies resource requirements, assists in budget planning and personnel forecasting for clinical research programs. Assists in the recruitment, training and development of the clinical teams to ensure efficient operation of the function. Identifies and selects clinical consultants. Collaborates with external opinion leaders. internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes Provides or assists in the scientific writing and review of clinical study reports and related documents. Provides periodic status updates and effectively communicate with Senior Management Team. Responsible for developing the infrastructure to support advanced clinical trials. Sets strategy for regulatory processes with responsibility for all submissions and interactions with the FDA and other regulatory authorities. Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing Other duties as assigned. Requirements: MS degree in Life Sciences or related field AND 10+ years of related experience in industry with expertise in the areas of drug development, operations and strategic plannings. Specialty training appropriate to therapeutic area in addition to experience in clinical drug development (Phase 1-4) in a pharmaceutical/biotechnology company. Prior experience working with CRO is a plus. Extensive previous managerial experiences also required OR PharmD or PhD degree preferred AND 7+ years of similar experience noted above. OR MD a plus AND 2+ years of similar experience noted above. Common Knowledge & Skills: Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required Ability to apply advanced analytical thought and judgment Strong leadership, coaching, employee development skills Ability to influence others with or without authority at all levels of the organization Proactive, innovative, with good problem-solving skills Ability to work in a cross functional team and matrix environment Excellent written, presentation, and verbal communication skills Job Specific Knowledge & Qualifications: Extensive knowledge of clinical drug development is mandatory and should include prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data. Must be able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of, internal and external personnel, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel. Expertise in the areas of drug development, operations and strategic planning. Expertise in submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through all clinical phases and product launch. 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 $195,500.00-$266,000.00. 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 35% 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. We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company. ©2025 Fortune Media IP Limited. All rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!

Responsibilities

The Director of Clinical Development is responsible for leading Phase 1-3 clinical study strategies and managing multidisciplinary teams to advance psychiatry programs. This role involves overseeing clinical trial operations, ensuring regulatory compliance, and analyzing study results for internal and external stakeholders.