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Preference for Hybrid Foster City, CA-Based Candidates

Are you a senior clinical operations professional who knows how to independently lead complex global clinical trials from start-up through closeout - while still staying deeply connected to the operational details that drive execution success?

This is a highly visible opportunity supporting large-scale global Phase 2b inflammation programs within a sponsor-dedicated environment, as a U.S.-based Global Study Lead. These pivotal programs span North America, Europe, APAC, Japan, and China, offering the opportunity to lead large-scale international clinical trials with significant visibility and impact.

We are seeking an experienced Senior Clinical Project Manager / Global Study Lead with a proven track record of leading pivotal global Phase 2b studies and driving trial execution with minimal oversight. Operating within a small, highly collaborative team, the successful candidate will bring demonstrated experience leading complex global programs, driving cross-functional accountability, navigating operational challenges, and delivering results in a matrixed environment.

This role is ideal for a seasoned clinical project leader who thrives in a high-ownership environment, is comfortable making critical decisions, influencing stakeholders, and taking full accountability for the successful delivery of global clinical trials.

**While remote/home-based candidates may be considered, priority will be given to candidates located in or near Foster City, California, with the ability to work onsite 2-3 days per week.**

• Lead pivotal, highly complex global Phase 2b inflammation studies

• Serve as Global Study Lead across North America, Europe, APAC, Japan, and China

• Operate with significant ownership and autonomy in a sponsor-dedicated environment

• Join a lean, highly collaborative team where independent leadership and sound decision-making are valued

• Partner directly with Sponsor stakeholders and senior leadership

• Play a visible role in the successful execution of critical clinical development programs

• Influence study strategy while maintaining hands-on operational leadership

• Contribute to globally significant programs with meaningful impact on patient care and drug development

Global Study Leadership

• Serve as the Global Study Lead for complex, pivotal Phase 2b inflammation studies

• Lead global study execution across North America, Europe, APAC, Japan, and China

• Provide strategic and operational leadership throughout study start-up, conduct, and closeout

• Act as the primary point of accountability for study delivery, quality, timelines, and execution

• Lead cross-functional global teams and drive alignment across internal stakeholders, vendors, and external partners

• Manage interdisciplinary clinical research programs in compliance with GCP, ICH guidelines, SOPs, and applicable regulatory requirements

• Serve as the primary liaison between the Sponsor and project stakeholders throughout the study lifecycle

• Maintain accountability for study deliverables, milestones, risks, budgets, and overall project performance

• Independently drive decision-making and execution while ensuring stakeholder alignment and operational excellence

Operational Oversight

• Coordinate activities and deliverables across CROs, vendors, and project partners

• Lead proactive risk identification, mitigation planning, and issue resolution activities

• Maintain oversight of project timelines, study trackers, key milestones, and critical deliverables

• Oversee inspection readiness activities, including Trial Master File strategy and oversight

• Ensure implementation of project plans in accordance with study requirements and controlled documents

• Anticipate operational challenges and independently develop solutions to maintain study timelines and quality standards

• Drive accountability across study teams to ensure successful execution and delivery

Leadership & Communication

• Lead global cross-functional teams and foster a culture of accountability, collaboration, and performance

• Independently prepare, coordinate, and present project materials during Sponsor, governance, and executive-level meetings

• Facilitate project-related discussions, issue escalation, and decision-making forums

• Direct activities of assigned project support staff and functional team members

• Mentor project management team members and clinical operations staff as appropriate

• Build strong working relationships across geographically dispersed teams and stakeholder groups

• Communicate effectively with senior leadership and executive stakeholders regarding study progress, risks, and mitigation strategies

Business & Strategic Support

• Participate in bid defense meetings as a potential project lead

• Support relationship development with current clients and stakeholders

• Maintain awareness of therapeutic area trends, competitive intelligence, and clinical development strategies within inflammation

• Contribute strategic insights that support successful study delivery and long-term program objectives

• Partner with leadership to identify opportunities for process improvements and operational efficiencies

Required Experience

• 5+ years of global clinical project management experience

• Demonstrated experience serving as the Global Study Lead for pivotal Phase 2b clinical trials

• Direct experience leading complex global studies across North America, Europe, APAC, Japan, and China

• Proven ability to independently lead global clinical trials with minimal oversight

• Demonstrated track record of autonomously leading complex global studies, driving cross-functional accountability, navigating operational challenges, and delivering successful outcomes within a global matrix environment

• Experience overseeing CROs, vendors, and external partners

• Strong pharmaceutical, biotechnology, CRO, or clinical research industry experience

• Experience managing study budgets, timelines, risks, and operational deliverables at a global level

Technical & Leadership Expertise

• Deep understanding of GCP, ICH guidelines, global regulatory requirements, drug development processes, and clinical trial operations

• Demonstrated success leading large, geographically dispersed global teams

• Strong strategic thinking, problem-solving, and decision-making capabilities

• Excellent communication, presentation, stakeholder management, and interpersonal skills

• Ability to influence without authority and drive accountability across cross-functional teams

• Strong organizational, planning, and project leadership skills

• Ability to effectively manage multiple priorities and deadlines in a fast-paced environment

• Comfortable operating independently while maintaining strong collaboration across stakeholders

• Experience navigating complex global clinical development environments with minimal supervision

• Proficiency with clinical trial systems, project management tools, and emerging technologies

The ideal candidate is a seasoned Global Study Lead with a proven history of successfully leading pivotal Phase 2b clinical trials on a global scale. They are highly autonomous, strategically minded, and comfortable operating in a lean team environment where independent leadership, sound judgment, and operational excellence are essential.

This individual possesses a demonstrated ability to lead complex global studies, drive cross-functional accountability, proactively manage risks, influence stakeholders at all levels, and deliver successful outcomes with minimal oversight. They thrive in environments that require ownership, initiative, and the ability to navigate ambiguity while maintaining focus on study quality, timelines, and overall program success.

If you are looking for an opportunity to lead globally visible inflammation programs, take full ownership of study execution, and play a critical role in the delivery of pivotal Phase 2b trials, we would welcome the opportunity to speak with you!