Sr. Clinical Program Manager

Neurocrine Biosciences

US CA San Diego Onsite Clinical Group

About this role

Who We Are:

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 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:

BS/BA degree in Life Sciences discipline AND 8+ 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 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 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
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

#LI-TM1

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.

The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. 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.