Cmc Program Manager Jobs in California (NOW HIRING)

Who We Are:

Neurocrine Biosciencesis 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 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, visitneurocrine.com, and follow the company onLinkedIn,X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:Lead drug development teams in partnership with the Program Lead, to develop cross-functional program strategy and long range plans from pre-clinical development through regulatory approval and commercialization. Drive team alignment in execution of the program plan following strong Project and Program Management theory and practice, including management of stakeholders, schedule, risks/issues, budget, resources and governance processes. Manage program reporting and escalate risks/issues to management as well as highlight team successes to the wider organization. Interact with stakeholders across the organization, including research, CMC, pre-clinical, clinical, regulatory and commercial functions to ensure alignment on program strategy, goals, timelines and resources.

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Your Contributions (include, but are not limited to):

• Partner with Program Lead and Development Team members to manage the development and execution of program strategy

• Establish and maintain functionally integrated program 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

• Lead scenario planning efforts to prepare teams for differing outcomes at key milestones

• Identify and leverage inter-dependencies in short-, mid-, and long-term program plans and advise teams on areas of risk or possibilities to accelerate development

• Challenge assumptions and provide recommendations to improve processes and outcomes

• Facilitate and document 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 Program Management expert resource for the broader organization

• Contribute to the development of the Program Management function through the introduction of new tools and/or processes

• Contribute to successful execution of Program Management department goals and activities

• May manage other 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

• PMP Certification highly desired

• Ability to lead cross-functional teams

• Good leadership and mentorship 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

• Demonstrated knowledge of project management practices, tools and methodology

• Knowledge of the drug development process and inter-dependencies between key functions including research, CMC, non-clinical development, clinical development and operations, and regulatory affairs

• Experience as a PM on early and late phase global drug development programs including some of: IND/CTA, NDA/MAA submissions, pediatric development, rare diseases

• Ability to manage conflict, drive consensus, and promote decision-making

• Ability to independently identify and manage project objectives, timelines, budgets, providing formal and informal status updates to stakeholders as needed

• Ability to challenge assumptions

• Proficiency in Planisware, Smartsheet, MS Project or other project management software

#LI-CL1

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.

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The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. 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.