Posted in Management 14 days ago.
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.
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)
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
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.