Sr. Program Manager, Drug Development

neurocrine; San Diego (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Neurocrine Biosciences seeks a senior Program Manager to lead end-to-end drug development programs from pre-clinical through regulatory submission and potential commercialization. You will guide cross-functional teams across research, CMC, clinical, regulatory and commercial functions to align strategy, timelines and resources.

The role requires strong project management discipline, risk management, stakeholder communication and the ability to navigate complex partnerships.

Qualifications

• Bachelor’s degree or higher in Life Sciences with 8+ years in pharma/biotech program management including IND/CTA, NDA/MAA submissions
• Master’s degree in Life Sciences with 6+ years of relevant experience
• PhD in Life Sciences with 4+ years of relevant experience
• PMP Certification highly desired

Responsibilities

• Lead program strategy from pre-clinical to regulatory approval and commercialization
• Interact with research, CMC, pre-clinical, clinical, regulatory and commercial functions for alignment
• Manage program reporting, risks/issues, schedule, budget, and governance
• Facilitate meetings, document decisions, and communicate updates to stakeholders
• Develop PM capabilities and introduce new tools/processes across the organization

Skills

Leadership

Cross-functional leadership

Stakeholder management

Risk management

Scenario planning

Decision making

Meeting facilitation

Communication

Mentorship

Program management

Budget management

Inter-department collaboration

Education

BS/BA Life Sciences

MS Life Sciences

PhD Life Sciences

Tools

Planisware

Smartsheet

MS Project

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

Lead drug development teams in partnership with the Program Lead, to develop cross-functional program strategy and long range plans from pre-clinical development through regulatory approval and commercialization. Drive team alignment in execution of the program plan following strong Project and Program Management theory and practice, including management of stakeholders, schedule, risks/issues, budget, resources and governance processes. Manage program reporting and elevate risk/issues to management as well as highlight team successes to the wider organization. Interact with stakeholders across the organization, including research, CMC, pre-clinical, clinical, regulatory and commercial functions to ensure alignment on program strategy, goals, timelines and resources.

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

• Partner with Program Lead and Development Team members to manage the development and execution of program strategy
• Establish and maintain functionally integrated program schedules in accordance with established structures to enable accurate project analyses, identification of critical path activities and areas of resource constraint
• Assess program risk and support mitigation planning and tracking
• Lead scenario planning efforts to prepare teams for differing outcomes at key milestones
• Identify and leverage inter-dependencies in short-, mid-, and long-term program plans and advise teams on areas of risk or possibilities to accelerate development
• Challenge assumptions and provide recommendations to improve processes and outcomes
• Facilitate and document meetings, cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership
• Develop relationships with key functional stakeholder groups and their leadership across the organization to support the execution of program goals
• Serve as a Program Management expert resource for the broader organization
• Contribute to the development of the Program Management function through the introduction of new tools and/or processes
• Contribute to successful execution of Program Management department goals and activities
• May manage other Program Management staff
• Other duties as assigned

Requirements:

• BS/BA degree in Life Sciences discipline and 8+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry, including experience with both early and late phase pharmaceutical program management including IND/CTA, NDA/MAA submissions. Experience managing global drug development efforts OR
• Master's degree in Life Sciences discipline and 6+ years of similar experience noted above OR
• PhD in Life Sciences discipline and 4+ years of similar experience noted above
• PMP Certification highly desired
• Ability to lead cross-functional teams
• Good leadership and mentorship skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company.
• Ability to meet multiple deadlines across a variety of projects/programs
• Demonstrated knowledge of project management practices, tools and methodology
• Knowledge of the drug development process and inter-dependencies between key functions including research, CMC, non‑clinical development, clinical development and operations, and regulatory affairs
• Experience as a PM on early and late phase global drug development programs including some of: IND/CTA, NDA/MAA submissions, pediatric development, rare diseases
• Ability to manage conflict, drive consensus, and promote decision‑making
• Ability to independently identify and manage project objectives, timelines, budgets, providing formal and informal status updates to stakeholders as needed
• Ability to challenge assumptions
• Proficiency in Planisware, Smartsheet, MS Project or o