Sr. Clinical Program Manager-Contractor

Neurocrine Biosciences•San Diego, CA

About The Position

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
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
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

Responsibilities

Partner with Clinical Sub-team Functional Leaders to manage the development and execution of Clinical program team strategy
Establish and maintain Clinical Development Plans schedules in accordance with established structures to enable accurate project analyses, identification of critical path activities and areas of resource constraint
Collaborate with Clinical Operations Directors (or designee) to manage clinical program objectives, work plans, timelines, budgets providing formal and informal updates
Assess clinical program risk and support mitigation planning including scenario planning with budget implications.
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