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:
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 Clinical Development Plans 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.
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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 Clinical Development Plans schedules in accordance with established structures to enable accurate project analyses, identification of critical path activities and areas of resource constraint
- Collaborate with Clinical Operations Directors (or designee) to manage clinical program objectives, work plans, timelines, budgets providing formal and informal updates
- Assess clinical program risk and support mitigation planning including scenario planning with budget implications.
- 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:
- BS/BA degree in Life Sciences discipline and 12+ 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 10+ years of similar experience noted above OR
- PhD in Life Sciences discipline and 7+ years of similar experience noted above
- PMP Certification highly desired
- Anticipates business and industry issues; recommends relevant process / technical / service improvements
- Demonstrates broad expertise or unique knowledge
- Considered an expert within the company and may have external presence in area of expertise
- Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
- Ability to work as part of and lead multiple teams
- Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
- Excellent computer 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, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Ability to effectively interact with individuals at all levels across the organization
- 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 with both early and late phase pharmaceutical program management including IND/CTA, NDA/MAA submissions
- 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
- Ability to manage conflict, drive consensus, and promote decision-making
- Ability to independently identify and manage project objectives, work plans, timelines, budgets, providing formal and informal status updates to stakeholders as needed
- Ability to challenge assumptions
- Proficiency in Smartsheet
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.