Sr. Clinical Program Manager at Neurocrine Biosciences in San Diego, California

Posted in Management 14 days ago.





Job Description:

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 patient suffering and enhance lives.

What We Do:

Neurocrine Biosciencesis a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered inSan Diego,Neurocrine Biosciencesspecializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

About the Role:

Among other responsibilities, the Sr. Clinical Program Manager will support one or more Clinical Development teams of higher complexity and/or strategic importance to drive team performance and communication. The individual will 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, and highlight team successes to the wider organization. In addition, the individual will 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, and apply best practices in the development, initiation, planning, execution, control and closing of projects. The Sr. Clinical Program Manager will 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 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 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


  • 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


Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.