Senior Clinical Program Manager – Contractor

🕒 April 14

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Neurocrine Biosciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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.

📋 Description

• 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.

🎯 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 • 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 • 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

🏖️ Benefits

• Health insurance • 401(k) • Paid time off • Flexible work arrangements • Professional development • Bonuses • Remote work options