Senior Director, Clinical Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee and execute global Phase 1-4 clinical trials

• Lead early development studies, including First-In-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and other early-phase designs

• Manage the complete operational strategy and execution for developmental programs across various studies and regions

• Create and uphold integrated study plans

• Engage in the design, implementation, and review of clinical protocols and study reports

• Ensure that milestones are achieved with high standards, meticulous attention to detail, and effective risk mitigation

• Select Contract Research Organizations (CROs), clinical pharmacology units, and key vendors

• Establish governance and oversight frameworks for accountability, performance, and predictable outcomes

• Identify, assess, manage, and sustain relationships with clinical trial sites and Principal Investigators

• Support comprehensive protocols, site selection, patient recruitment, and enrollment objectives

• Collaborate with Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC, and Translational stakeholders

• Drive feasibility assessments, study start-up, vendor management, enrollment execution, data quality, Trial Master File (TMF) and inspection readiness, closeout, and timely execution of studies

• Deliver high-quality clinical study data and present findings to cross-functional teams and external stakeholders

• Navigate through ambiguity, identify challenges, propose solutions, make informed decisions, and facilitate team progress

• Develop and enhance clinical operations processes, templates, and performance metrics

• Contribute to pipeline expansion, operational diligence, and integration planning

• Maintain advanced knowledge of the therapeutic area, product, clinical trial environment, literature, competitive intelligence, and treatment paradigms

• Oversee team training and collaborate with Quality Assurance on GxP-compliant training initiatives

• Lead or assist in drafting, reviewing, and approving clinical project deliverables, submissions, monitoring plans, Case Report Forms (CRFs), data management plans, safety plans, charters, closeout plans, inspection readiness plans, and Clinical Study Reports (CSRs)

⛳️ Requirements

• BA/BS or equivalent in a scientific or health-related field; advanced degree is preferred

• More than 12 years of clinical operations or clinical management experience with increasing levels of scope and responsibility

• Senior leadership experience in managing programs and/or teams

• Direct experience in managing clinical operations in international markets such as Canada and the UK

• Operations experience in Neurology or rare diseases is preferred

• Proven track record of success in leading international trials and managing complex vendor ecosystems

• Hands-on experience in conducting Phase 1-4 trials, healthy volunteer studies, SAD/MAD/Proof of Concept (PoC) in the US and abroad

• Strong understanding of ICH-GCP and global clinical operations best practices

• Excellent quality mindset and experience in inspection readiness

• Proven capability to lead through influence, align diverse stakeholders, and drive execution in a lean environment

• Ability to function effectively amidst high ambiguity, establish direction, make decisions, and take accountability for outcomes

• Exceptional organizational, prioritization, multitasking, verbal, and written communication skills

• Strategic thinker with proactive problem identification, sound judgment, and problem-solving abilities

• Capability to operate and collaborate at all project levels, from oversight to hands-on management of daily activities

• Willingness to travel as needed, consistent with project requirements

🏝️ Benefits

• Patient Days

• Culture inspired by company values

• Access to learning and development resources

• Robust and market-competitive compensation and benefits package

• Performance bonus

• Equity opportunities

• Health programs

• Welfare programs

• Retirement programs

• Flexible Paid Time Off (PTO)

• Rapid career advancement for high performers

• Potential to work on multiple BridgeBio Pharma programs across various therapeutic areas

• Partnerships with leading institutions