Senior Manager, Clinical Program Planning
Pacira BioSciences, Inc.
5 hours ago
Remote friendly (Parsippany, NJ)
United States
Clinical Research and Development
Clinical Program Oversight
- Coordinate and project manage cross-functional strategic initiatives focused on HEOR, Late-Stage Research, and Publications/Scientific Communications across Clinical Affairs.
- Develop and maintain clinical program roadmaps, dashboards, and KPIs for visibility into progress, risks, and strategic opportunities.
- Support governance activities, including portfolio operational reviews and clinical executive meetings.
- Oversee clinical study/program timelines from planning through close-out; monitor and report milestones across Phase 1–4, proactively managing dependencies and critical path activities.
- Identify and escalate operational risks and delays; ensure timely mitigation and leadership awareness.
- Provide accurate milestone and resource-tracking insights to drive data-informed decision-making.
- Facilitate engagement forums to promote transparency, collaboration, and operational excellence.
Operational Excellence, Performance Management & Continuous Improvement
- Design, implement, and oversee comprehensive tracking systems for Clinical Affairs sub-functions.
- Integrate sub-functional plans into a unified portfolio for data-driven portfolio management and performance tracking.
- Ensure tools and trackers maintain inspection readiness and meet quality and compliance standards.
- Standardize processes and develop playbooks to improve efficiency, consistency, and scalability.
- Apply project management methodologies (risk management, scenario planning, change control) to strengthen delivery.
- Lead or contribute to process improvement initiatives, including adoption of digital PM tools (e.g., MS Project/Project Online, Planisware, Smartsheet) and data visualization dashboards (Power BI, Tableau, Spotfire).
Cross-Functional and External Collaboration
- Collaborate with internal and external partners to ensure seamless cross-functional execution.
- Translate complex clinical and operational information into executive-level presentations.
Supervisory Responsibilities
- None.
Qualifications
- Bachelor’s degree in Life Sciences, Business, Engineering, or related field required; advanced degree preferred.
- Minimum 6 years of progressive experience in clinical program management, clinical development, or clinical operations in biotechnology/pharmaceutical industry.
- Proven history leading cross-functional clinical programs or strategic operations initiatives.
- Preferred: experience supporting/managing projects involving HEOR, late-stage research, or post-marketing studies; demonstrated end-to-end clinical program delivery (stage-gate planning, protocol development through CSR, regulatory submission, and publications) with strong timeline, planning, and milestone tracking across all clinical phases.
- Strong background developing project tracking systems, dashboards, or governance tools.
- Experience leading/mentoring cross-functional teams and structured change management practices.
Certifications (Preferred)
- PMP certification (or equivalent training).
- Lean Six Sigma Green or Black Belt.
Knowledge, Skills, and Abilities (Required)
- Leadership/influence aligning stakeholders across clinical and corporate functions.
- Advanced organizational and project management skills; operational rigor and execution.
- Strategic/analytical mindset leveraging data to optimize planning and identify risks.
- Excellent communication and presentation skills for scientific and executive audiences.
- Agile/resilient in ambiguity and shifting priorities.
- Proficiency in Microsoft Office Suite (Word, Excel, Project, Outlook), Smartsheet, and PM systems (MS Project/Project Online, Planisware, Smartsheet) plus data visualization dashboards (Power BI, Tableau, Spotfire, etc.).
- Travel up to 20% as needed.
Benefits
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with company match
- Employee Assistance Program; Mental Health Resources
- Disability Coverage; Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
- Coordinate and project manage cross-functional strategic initiatives focused on HEOR, Late-Stage Research, and Publications/Scientific Communications across Clinical Affairs.
- Develop and maintain clinical program roadmaps, dashboards, and KPIs for visibility into progress, risks, and strategic opportunities.
- Support governance activities, including portfolio operational reviews and clinical executive meetings.
- Oversee clinical study/program timelines from planning through close-out; monitor and report milestones across Phase 1–4, proactively managing dependencies and critical path activities.
- Identify and escalate operational risks and delays; ensure timely mitigation and leadership awareness.
- Provide accurate milestone and resource-tracking insights to drive data-informed decision-making.
- Facilitate engagement forums to promote transparency, collaboration, and operational excellence.
Operational Excellence, Performance Management & Continuous Improvement
- Design, implement, and oversee comprehensive tracking systems for Clinical Affairs sub-functions.
- Integrate sub-functional plans into a unified portfolio for data-driven portfolio management and performance tracking.
- Ensure tools and trackers maintain inspection readiness and meet quality and compliance standards.
- Standardize processes and develop playbooks to improve efficiency, consistency, and scalability.
- Apply project management methodologies (risk management, scenario planning, change control) to strengthen delivery.
- Lead or contribute to process improvement initiatives, including adoption of digital PM tools (e.g., MS Project/Project Online, Planisware, Smartsheet) and data visualization dashboards (Power BI, Tableau, Spotfire).
Cross-Functional and External Collaboration
- Collaborate with internal and external partners to ensure seamless cross-functional execution.
- Translate complex clinical and operational information into executive-level presentations.
Supervisory Responsibilities
- None.
Qualifications
- Bachelor’s degree in Life Sciences, Business, Engineering, or related field required; advanced degree preferred.
- Minimum 6 years of progressive experience in clinical program management, clinical development, or clinical operations in biotechnology/pharmaceutical industry.
- Proven history leading cross-functional clinical programs or strategic operations initiatives.
- Preferred: experience supporting/managing projects involving HEOR, late-stage research, or post-marketing studies; demonstrated end-to-end clinical program delivery (stage-gate planning, protocol development through CSR, regulatory submission, and publications) with strong timeline, planning, and milestone tracking across all clinical phases.
- Strong background developing project tracking systems, dashboards, or governance tools.
- Experience leading/mentoring cross-functional teams and structured change management practices.
Certifications (Preferred)
- PMP certification (or equivalent training).
- Lean Six Sigma Green or Black Belt.
Knowledge, Skills, and Abilities (Required)
- Leadership/influence aligning stakeholders across clinical and corporate functions.
- Advanced organizational and project management skills; operational rigor and execution.
- Strategic/analytical mindset leveraging data to optimize planning and identify risks.
- Excellent communication and presentation skills for scientific and executive audiences.
- Agile/resilient in ambiguity and shifting priorities.
- Proficiency in Microsoft Office Suite (Word, Excel, Project, Outlook), Smartsheet, and PM systems (MS Project/Project Online, Planisware, Smartsheet) plus data visualization dashboards (Power BI, Tableau, Spotfire, etc.).
- Travel up to 20% as needed.
Benefits
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with company match
- Employee Assistance Program; Mental Health Resources
- Disability Coverage; Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave