Neurocrine
Sr. Clinical Program Manager-Endocrinology
US CA San Diego · Senior
Sponsorship not specified$157k-$214kDetected 26 days ago
Project ManagementFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationCollaborationProblem SolvingMentoringBiostatistics
About the role
- Ensure that Clinical team activities are aligned to goals and timelines as set out by the Core Development Team.
- Highlight team successes to the wider organization.
- Help ensure consistent practices throughout all phases of the project life cycle.
Responsibilities
- Support one or more Clinical Development teams for our Obesity programs.
- Work with the Clinical Team to deliver milestones on or ahead of schedule and escalate issues that require Core Development Team review.
- 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
- Develop relationships with key functional stakeholder groups and their leadership across the organization to support the execution of program goals
- May manage other Clinical Program Management staff
Requirements
- Experience managing global drug development efforts.
- 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
- Demonstrated knowledge of project management practices, tools and methodology
- Knowledge of Clinical development process and inter-dependencies of key functions to include research, CMC, non-clinical development, clinical, and manufacturing
- Experience managing global Clinical development efforts
- Excellent team member with a strong willingness and ability to work across projects at different stages of development in a fast-paced, entrepreneurial environment
- Proficiency in Smartsheet
- Experience with both early and late phase pharmaceutical program management including IND/CTA, NDA/MAA submissions.
- Demonstrates broad expertise or unique knowledge
Skills
- Contribute to development efforts by leveraging network of experts and experienced vendors to solve Clinical development challenges
- 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
Compensation
- The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00.
Company info
- 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 )
- About the Role:
- Support one or more Clinical Development teams for our Obesity programs. 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):
- 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 )
- to relieve suffering for people with great needs.
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