Senior Program Manager (Clinical)

Barrington James; San Jose (CA); In loco; USD 140.000 - 190.000; Tempo pieno

Descrizione del lavoro

Barrington James is seeking an experienced Senior Program Manager (Clin Ops & Clin Dev) to provide strategic leadership and hands-on execution across a complex clinical portfolio in a global biopharma setting.

You will collaborate with Clinical Development, Operations, Regulatory, Medical Affairs, CMC, and external CRO/vendor partners to align strategy with integrated execution plans and governance. Must have strong communication skills and a track record of cross-functional delivery.

Competenze

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 6+ years in program or project management within pharma, biotech, CRO, or related life sciences.
• Experience managing complex clinical development programs through late-stage development and NDA submission.

Mansioni

• Lead integrated program planning across multiple clinical studies with milestones and critical path activities.
• Translate strategic priorities into executable program plans and assess impacts on timelines.
• Establish and maintain program governance, cadences, decision pathways, RAID, and reporting.
• Prepare executive-level materials and dashboards on overall program health and milestones.
• Maintain RAID and decision logs with clear ownership and follow-up.
• Identify schedule risks and resource constraints; coordinate mitigation with stakeholders.
• Coordinate execution across Clinical Operations, Data Management, Biostatistics, Regulatory, Medical Writing, Quality, and other functions.
• Provide hands-on PM support to studies and workstreams as needed.
• Collaborate with CROs and external vendors to update integrated plans and monitor commitments.
• Oversee vendor contracts, change orders, invoices, accruals, and budget forecasting.
• Identify opportunities to improve portfolio planning, governance, and reporting.
• Drive adoption of PM tools, dashboards, and standardized reporting processes.
• Support cross-functional decision-making with data, risks, and scenarios for leadership.
• Escalate key clinical development risks and decisions through governance.

Conoscenze

Program management

Cross-functional leadership

Governance

Executive communication

Risk and issue management

Vendor management

Strategic planning

Formazione

Bachelor's degree in Life Sciences

Advanced degree preferred

Descrizione del lavoro

We are partnered with a global biopharmaceutical company as they continue to expand their Clinical Development organization and advance a portfolio of programs through late-stage development and toward regulatory submission. They are looking to appoint an experienced Senior Program Manager (Clin Ops & Clin Dev) to provide strategic program leadership while driving day-to-day execution across a complex clinical portfolio.

This is a highly visible role within Program Management & Operations, working closely with senior Clinical Development and Operations leadership to translate development strategy into clear, integrated execution plans. The position will bring together timelines, milestones, risks, dependencies, resources, and key decisions across multiple functions and external partners, helping ensure programs remain aligned and on track.

The successful candidate will operate across Clinical Development, Clinical Operations, Regulatory, Medical Affairs, CMC, Nonclinical, Quality, Commercial, and external CRO/vendor partners. This is an opportunity for an experienced program manager who enjoys operating at both a strategic and hands-on level, with significant exposure to governance, executive reporting, portfolio planning, and cross-functional decision-making.

Key Responsibilities

• Lead integrated program planning across multiple clinical studies, ensuring alignment of milestones, dependencies, deliverables, and critical path activities
• Partner closely with Clinical Development and Operations leadership to translate strategic priorities into executable program plans and identify potential impacts to overall development timelines
• Establish and maintain effective program governance, including operating cadences, governance forums, decision pathways, RAID frameworks, and program reporting
• Prepare executive-level materials and dashboards highlighting overall program health, milestone progress, critical path activities, risks, dependencies, and key decisions required
• Maintain program RAID and decision logs, ensuring actions are clearly documented, appropriately owned, and followed through to resolution
• Proactively identify schedule risks, resource constraints, cross-functional dependencies, and operational issues, coordinating mitigation strategies with relevant stakeholders
• Coordinate execution across Clinical Operations, Study Management, Data Management, Biostatistics, Safety, Regulatory Affairs, Medical Writing, Quality, and other development functions
• Provide hands-on project management support to individual studies and workstreams where required
• Work closely with CROs and external vendors to incorporate operational updates into integrated plans, monitor commitments, and ensure appropriate follow-up
• Support oversight of vendor and financial activities, including purchase orders, change orders, invoices, accruals, contracts, and budget forecasting
• Identify opportunities to improve portfolio planning, governance, reporting, and overall operational effectiveness
• Drive adoption and consistent use of program management tools, templates, dashboards, and standardized reporting processes
• Support cross-functional decision-making by bringing together relevant data, risks, scenarios, and recommendations for senior leadership
• Collaborate with Enterprise Program Management to ensure key Clinical Development risks, dependencies, and decisions are appropriately escalated through broader organizational governance

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline; advanced degree preferred
• 6+ years of program or project management experience within the pharmaceutical, biotechnology, medical device, CRO, or related life sciences environment
• Demonstrated experience managing complex clinical development programs through late-stage development and toward NDA or equivalent regulatory submission
• Strong track record of leading cross-functional planning and execution across multiple concurrent clinical studies
• Experience working across Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Quality, and other key development functions
• Strong understanding of clinical development processes from study start-up through close-out and regulatory submission
• Extensive experience with integrated timelines, critical path management, risk and issue management, dependencies, and cross-functional planning
• Previous experience working with CROs, vendors, and external development partners
• Strong executive communication and presentation skills, with the ability to distill complex program information into clear recommendations and decision points
• Experience contributing to the development or implementation of clinical program governance frameworks