Sr. Clinical Program Manager-Contractor
Neurocrine Biosciences
5 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
- Support one or more Clinical Development teams of higher complexity and/or strategic importance to drive team performance and communication.
- Ensure Clinical team activities align with goals and timelines set by the Core Development Team.
- Deliver milestones on or ahead of schedule; escalate issues requiring Core Development Team review.
- Help drive creation and execution of Clinical Development Plans within budget, scope, and schedule.
- Apply best practices across development, initiation, planning, execution, control, and closing.
- Interact with program stakeholders (Clinical Operations, Drug Safety/Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, Regulatory) to align on goals, timelines, and required resources.
Your Contributions (include, but are not limited to)
- Partner with Clinical Sub-team Functional Leaders to manage Clinical program team strategy.
- Establish and maintain Clinical Development Plans schedules for accurate analyses, critical path identification, and resource constraint awareness.
- Collaborate with Clinical Operations Directors to manage objectives, work plans, timelines, budgets; provide updates.
- Assess clinical program risk and support mitigation planning (including scenario planning with budget implications).
- Lead site activation and enrollment scenario planning for aggressive but realistic study timelines; develop mitigation/contingency strategies.
- Manage external partner relationships and deliverables (as applicable).
- Identify inter-dependencies across short-, mid-, and long-term plans; advise on risk and acceleration opportunities.
- Challenge assumptions and recommend process improvements.
- Leverage experts and vendors to solve Clinical development challenges.
- Facilitate/document Clinical Sub-team meetings and cross-functional communication/decision-making.
- Serve as a Clinical Program Management expert resource; contribute to new tools/processes.
- May manage other Clinical Program Management staff.
Requirements
- BS/BA in Life Sciences + 12+ years pharmaceutical/biotech multi-disciplinary program management experience (early and late phase; IND/CTA, NDA/MAA), including global drug development OR
- Master’s in Life Sciences + 10+ years OR
- PhD in Life Sciences + 7+ years.
- PMP certification highly desired.
- Excellent project management and leadership; ability to work as part of and lead multiple teams.
- Strong communications, problem-solving, analytical thinking; ability to interact effectively at all organizational levels.
- Demonstrated knowledge of project management practices/tools/methodology.
- Knowledge of clinical development process and inter-dependencies (research, CMC, non-clinical, clinical, manufacturing).
- Experience managing global Clinical development efforts.
- Ability to manage conflict, drive consensus, and promote decision-making.
- Ability to independently identify/manage project objectives, work plans, timelines, budgets; provide status updates.
- Ability to challenge assumptions.
- Proficiency in Smartsheet.
Application instructions
- Not specified.
- Support one or more Clinical Development teams of higher complexity and/or strategic importance to drive team performance and communication.
- Ensure Clinical team activities align with goals and timelines set by the Core Development Team.
- Deliver milestones on or ahead of schedule; escalate issues requiring Core Development Team review.
- Help drive creation and execution of Clinical Development Plans within budget, scope, and schedule.
- Apply best practices across development, initiation, planning, execution, control, and closing.
- Interact with program stakeholders (Clinical Operations, Drug Safety/Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, Regulatory) to align on goals, timelines, and required resources.
Your Contributions (include, but are not limited to)
- Partner with Clinical Sub-team Functional Leaders to manage Clinical program team strategy.
- Establish and maintain Clinical Development Plans schedules for accurate analyses, critical path identification, and resource constraint awareness.
- Collaborate with Clinical Operations Directors to manage objectives, work plans, timelines, budgets; provide updates.
- Assess clinical program risk and support mitigation planning (including scenario planning with budget implications).
- Lead site activation and enrollment scenario planning for aggressive but realistic study timelines; develop mitigation/contingency strategies.
- Manage external partner relationships and deliverables (as applicable).
- Identify inter-dependencies across short-, mid-, and long-term plans; advise on risk and acceleration opportunities.
- Challenge assumptions and recommend process improvements.
- Leverage experts and vendors to solve Clinical development challenges.
- Facilitate/document Clinical Sub-team meetings and cross-functional communication/decision-making.
- Serve as a Clinical Program Management expert resource; contribute to new tools/processes.
- May manage other Clinical Program Management staff.
Requirements
- BS/BA in Life Sciences + 12+ years pharmaceutical/biotech multi-disciplinary program management experience (early and late phase; IND/CTA, NDA/MAA), including global drug development OR
- Master’s in Life Sciences + 10+ years OR
- PhD in Life Sciences + 7+ years.
- PMP certification highly desired.
- Excellent project management and leadership; ability to work as part of and lead multiple teams.
- Strong communications, problem-solving, analytical thinking; ability to interact effectively at all organizational levels.
- Demonstrated knowledge of project management practices/tools/methodology.
- Knowledge of clinical development process and inter-dependencies (research, CMC, non-clinical, clinical, manufacturing).
- Experience managing global Clinical development efforts.
- Ability to manage conflict, drive consensus, and promote decision-making.
- Ability to independently identify/manage project objectives, work plans, timelines, budgets; provide status updates.
- Ability to challenge assumptions.
- Proficiency in Smartsheet.
Application instructions
- Not specified.