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Sr. Clinical Program Manager

External
neurocrine logoNeurocrine · San Diego, CA
Full-timeOn-siteToday
Leadership
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About the role

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 patients with 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 ) Support one or more Clinical Development teams of higher complexity and/or strategic importance to drive team performance and communication. Ensure that Clinical team activities are aligned to goals and timelines as set out by the Core Development Team. Work with the Clinical Team to deliver milestones on or ahead of schedule and escalate issues that require Core Development Team review. Highlight team successes to the wider organization. Play a key role in driving the creation and execution of integrated Clinical Development Plans (iCDPs) while adhering to budget, scope and schedule requirements. Help ensure consistent practices throughout all phases of the project life cycle. Apply best practices in the development, initiation, planning, execution, control and closing of projects. Interact with all program stakeholders including Clinical Operations, Drug Safety and Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, and Regulatory departments to ensure alignment on Clinical program goals, timelines, and resources required. _ Your Contributions (include, but are not limited to): Partner with Clinical Sub-team Functional Leaders to manage the development and execution of Clinical program team strategy Establish and maintain iCDP 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 Independently identify and manage Clinical program objectives, work plans, timelines, budgets, providing formal and informal status updates to stakeholders as needed Lead site activation and enrollment scenario planning efforts to generate aggressive but realistic study timelines, including mitigation and contingency strategies to deliver studies on time Manage relationships and deliverables with external partners (as applicable), tracking and delivering on obligations in a timely manner Identify and leverage inter-dependencies in short-, mid-, and long-term Clinical program plans and advise teams on areas of risk or possibilities to accelerate development Challenge assumptions and provide recommendations to improve processes and outcomes Contribute to development efforts by leveraging network of experts and experienced vendors to solve Clinical development challenges Facilitate and document Clinical Sub-team 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 Clinical Program Management expert resource for the broader organization Contribute to the development of the Clinical Program Management function through the introduction of new tools and/or processes Contribute to successful execution of Clinical Program Management department goals and activities May manage other Clinical Program Management staff Other duties as assigned

Requirements

  • 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 OR
  • PMP Certification highly desired
  • Demonstrated knowledge of project management practices, tools and methodology
  • Knowledge of Clinical development process and inter-dependencies of key functions to i

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