Sr. Clinical Program Manager-Contractor
Neurocrine Biosciences
4 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Support one or more Clinical Development teams to drive team performance and communication. Align clinical activities with Core Development Team goals and timelines; deliver milestones on or ahead of schedule and escalate issues requiring Core Development Team review. Drive Clinical Development Plans (adhering to budget, scope, and schedule), ensure consistent practices across the project life cycle, and apply best practices across project development through closing. Partner with program stakeholders (Clinical Operations, Drug Safety/Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, Regulatory) to ensure alignment 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/maintain Clinical Development Plan schedules to enable project analysis and identify critical path/resource constraints.
- Collaborate with Clinical Operations Directors to manage objectives, work plans, timelines, and budgets with formal/informal updates.
- Assess clinical program risk and develop mitigation plans (including scenario planning with budget implications).
- Lead site activation and enrollment scenario planning to deliver aggressive but realistic study timelines.
- Manage external partner relationships/deliverables and track obligations.
- Identify inter-dependencies across short-, mid-, and long-term plans; advise on risk and acceleration opportunities.
- Challenge assumptions; recommend improvements to processes and outcomes.
- 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; may manage other staff.
- Contribute to tooling/process improvements for Clinical Program Management.
Requirements
- BS/BA in Life Sciences + 12+ years multi-disciplinary pharma/biotech experience OR Master’s + 10+ years OR PhD + 7+ years.
- Experience managing early and late phase pharmaceutical program management, including IND/CTA and NDA/MAA submissions; experience managing global drug development efforts.
- PMP certification highly desired.
Skills
- Leadership/mentoring; ability to work as part of and lead multiple teams.
- Strong project management and leadership; demonstrated project management knowledge/tools/methodology.
- Excellent communications, problem-solving, analytical thinking.
- Ability to meet multiple deadlines with accuracy/efficiency; interact effectively at all organizational levels.
- Knowledge of clinical development process and inter-dependencies (research, CMC, non-clinical, clinical, manufacturing).
- Ability to manage conflict, drive consensus, and promote decision-making.
- Proficiency in Smartsheet.
Support one or more Clinical Development teams to drive team performance and communication. Align clinical activities with Core Development Team goals and timelines; deliver milestones on or ahead of schedule and escalate issues requiring Core Development Team review. Drive Clinical Development Plans (adhering to budget, scope, and schedule), ensure consistent practices across the project life cycle, and apply best practices across project development through closing. Partner with program stakeholders (Clinical Operations, Drug Safety/Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, Regulatory) to ensure alignment 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/maintain Clinical Development Plan schedules to enable project analysis and identify critical path/resource constraints.
- Collaborate with Clinical Operations Directors to manage objectives, work plans, timelines, and budgets with formal/informal updates.
- Assess clinical program risk and develop mitigation plans (including scenario planning with budget implications).
- Lead site activation and enrollment scenario planning to deliver aggressive but realistic study timelines.
- Manage external partner relationships/deliverables and track obligations.
- Identify inter-dependencies across short-, mid-, and long-term plans; advise on risk and acceleration opportunities.
- Challenge assumptions; recommend improvements to processes and outcomes.
- 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; may manage other staff.
- Contribute to tooling/process improvements for Clinical Program Management.
Requirements
- BS/BA in Life Sciences + 12+ years multi-disciplinary pharma/biotech experience OR Master’s + 10+ years OR PhD + 7+ years.
- Experience managing early and late phase pharmaceutical program management, including IND/CTA and NDA/MAA submissions; experience managing global drug development efforts.
- PMP certification highly desired.
Skills
- Leadership/mentoring; ability to work as part of and lead multiple teams.
- Strong project management and leadership; demonstrated project management knowledge/tools/methodology.
- Excellent communications, problem-solving, analytical thinking.
- Ability to meet multiple deadlines with accuracy/efficiency; interact effectively at all organizational levels.
- Knowledge of clinical development process and inter-dependencies (research, CMC, non-clinical, clinical, manufacturing).
- Ability to manage conflict, drive consensus, and promote decision-making.
- Proficiency in Smartsheet.