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San Diego, California, United States
Onsite
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)
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Program and Project Management
Lead the integrated planning and execution of assigned Technical Operations and CMC programs, initiatives, and major workstreams from development planning through key program milestones
Develop, maintain, and communicate integrated program plans, timelines, milestones, critical paths, dependencies, decision points, and key deliverables
Establish and manage appropriate meeting cadences, governance forums, decision logs, action trackers, and status reporting mechanisms
Monitor execution against agreed plans and proactively identify schedule risks, resource constraints, cross-functional dependencies, and emerging issues
Partner with functional subject-matter experts to evaluate options, develop mitigation strategies, and support timely resolution or escalation of issues
Facilitate scenario planning and trade-off discussions to enable informed decisions related to timelines, sequencing, dependencies, and execution priorities
Maintain clear documentation of key program assumptions, decisions, risks, actions, and accountabilities
CMC and Technical Operations Integration
Apply working knowledge of CMC development disciplines—including API/drug substance, analytical development, pharmaceutical/drug product development, manufacturing, supply chain, quality, and regulatory activities—to effectively integrate cross-functional plans
Understand upstream and downstream impacts of Technical Operations activities and proactively connect interdependent work across functions
Partner with technical leaders to translate functional strategies and technical activities into coordinated program-level plans and milestones
Facilitate alignment between Technical Operations activities and broader Research, Clinical Development, Regulatory, Quality, and portfolio objectives
Support development and maintenance of integrated CMC strategies, timelines, and readiness plans for key development and regulatory milestones
Serve as the program management representative for assigned Technical Operations initiatives and provide clear, data-driven recommendations to program and functional leadership
Strategic and Operational Support
Support execution of departmental and functional priorities by translating strategic objectives into clear tactical plans, deliverables, timelines, and ownership
Provide leadership with accurate and timely visibility into program progress, risks, resource constraints, decisions, and key operational considerations
Facilitate departmental, program, or cross-functional planning sessions and ensure resulting decisions and actions are appropriately documented and followed through
Analyze program information and operating trends to identify near-term challenges, opportunities, and downstream impacts
Recommend practical changes to operating approaches, processes, or governance mechanisms when they will improve execution or team effectiveness
Contribute to resource and capacity discussions by providing visibility into workload, timing, dependencies, and program priorities
Risk, Issue, and Decision Management
Establish disciplined approaches for identifying, assessing, tracking, and communicating program risks and issues
Work with team members and functional leaders to develop mitigation and contingency plans for material risks
Ensure decisions are supported by relevant data, clearly documented, and translated into updated plans and accountabilities
Recognize when issues require broader leadership involvement and facilitate timely escalation with clear options and recommendations
Monitor the outcomes of significant decisions and adjust plans as necessary to maintain progress toward objectives
Promote a solutions-oriented team environment in which issues are surfaced early and accompanied by proposed paths forward
Operational Excellence
Identify and implement opportunities to improve program management processes, workflows, governance practices, and cross-functional collaboration
Standardize fit-for-purpose templates, planning approaches, dashboards, metrics, and reporting mechanisms where appropriate
Partner with stakeholders to support adoption of new project management systems, digital tools, data capabilities, and operating practices
Use data and stakeholder feedback to assess effectiveness of existing processes and recommend improvements
6+ years of applicable experience AND Bachelor’s degree OR
4+ years of applicable experience AND Master’s degree OR
2+ years of applicable experience AND PharmD, or PhD
Direct experience supporting CMC, Technical Operations, or manufacturing is required
Program/project management experience within pharmaceutical, biotechnology, or drug development environments is preferred. Experience supporting analytical activities, formulation development, or related functions is also preferred
Strong working knowledge of pharmaceutical development and CMC/Technical Operations activities across the product development lifecycle
Working knowledge of core CMC disciplines, including Drug Substance/API Development, Analytical Development, Drug Product/Pharmaceutical Development, Manufacturing, Supply Chain, Quality, and CMC Regulatory
Ability to integrate technical plans, milestones, dependencies, risks, and deliverables across multiple CMC disciplines, sub-teams, and workstreams
Understanding of upstream and downstream dependencies among CMC/Technical Operations activities and their potential impact on broader development program timelines and objectives
Understanding of the interfaces among Technical Operations, Research, Clinical Development, Regulatory Affairs, Quality, Supply Chain, Finance, and other development functions
Knowledge of CMC planning and readiness requirements associated with key development, manufacturing, clinical supply, and regulatory milestones
Ability to partner effectively with technical and functional subject-matter experts and translate complex technical strategies and activities into integrated program plans, milestones, risks, and execution priorities
Ability to facilitate scenario planning and trade-off discussions involving timelines, sequencing, resource constraints, technical dependencies, and execution priorities
Understanding of program governance, risk management, decision management, and escalation practices within a pharmaceutical development and Technical Operations environment
Familiarity with resource and capacity planning and the ability to provide leadership with meaningful visibility into workload, timing, dependencies, constraints, and program priorities
Strong program and project management skills, with demonstrated ability to manage multiple complex programs, projects, or workstreams with competing priorities and deadlines
Strong planning and organizational skills, with the ability to develop and maintain integrated plans, timelines, milestones, dependencies, critical paths, risks, and deliverables
Strong cross-functional collaboration and influencing skills, with the ability to build alignment, facilitate productive discussions, and drive execution in a matrixed environment
Strong analytical, critical-thinking, and problem-solving skills, with the ability to evaluate complex information, identify risks and dependencies, develop options, and make sound recommendations
Excellent written and verbal communication skills, with the ability to synthesize complex information and communicate program status, risks, decisions, and recommendations clearly to diverse audiences, including senior leaders
Demonstrated ability to facilitate meetings, planning sessions, governance forums, scenario discussions, and decision-making processes involving multiple functions and stakeholders
Ability to operate with a high degree of independence within established objectives, exercising sound judgment regarding when to resolve issues directly and when escalation or broader leadership involvement is appropriate
Strong understanding of risk, issue, dependency, and decision management practices and their application to complex development programs
Ability to understand broader organizational objectives and downstream impacts and translate strategic or program objectives into actionable plans, priorities, and execution activities
Strong continuous-improvement mindset, with the ability to identify and recommend improvements to processes, workflows, governance, tools, reporting, and ways of working
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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.
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The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. 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 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.