Senior Director, Clinical Operations Business & Excellence

Accountabilities

• Clinical Business Office Strategy and Financial Management: Establish and lead the centralized Clinical Operations Business Office, defining its operating model, responsibilities, decision-making authority, service expectations, and collaboration processes with study teams.

• Own the Business Office roadmap, annual objectives, and performance metrics while overseeing resource and capability planning. Recommend internal capabilities and external service models that align with portfolio priorities and reduce duplication across programs.

• Adapt the operating model as clinical portfolio complexity and organizational requirements evolve, ensuring resources and processes remain fit for purpose.

• Vendor Governance and Site Contracting: Contribute to commercial strategy and oversee complex negotiations involving master service agreements, statements of work, and contract amendments in collaboration with Legal, Procurement, and Finance.

• Establish consistent negotiation, escalation, financial planning, and change-control practices, ensuring vendor commitments support quality, delivery, cost, and broader portfolio objectives.

• Lead the centralized site contracting and budgeting model, overseeing clinical trial agreement workflows, investigator budget templates, negotiation practices, and service-provider performance to improve consistency and accelerate study startup.

• Establish vendor governance frameworks, performance indicators, service expectations, and escalation pathways. Lead strategic business reviews, resolve significant performance issues, and oversee recovery plans and recommendations concerning vendor partnerships.

• Trial Master File and Inspection Readiness: Own the electronic Trial Master File (eTMF) governance strategy, including document standards, ownership, completeness, filing timelines, data integrity, access, retention, and reliable record retrieval.

• Establish portfolio-wide inspection-readiness practices through risk-based TMF health checks, quality metrics, and consistent accountability across study teams and vendors.

• Provide development leadership with consolidated visibility into inspection readiness, recurring risks, documentation gaps, and remediation progress.

• Coordinate Business Office preparation and operational support for audits, mock inspections, and health authority inspections in partnership with Quality. Lead Business Office remediation activities and CAPAs, ensuring timely completion and effectiveness assessments while preserving Quality's independent oversight.

• Risk-Based Quality Management and Process Improvement: Establish a consistent portfolio-wide approach to risk-based quality management in partnership with study teams, Quality, and Biometrics. Define processes for critical-to-quality factors, key risk indicators, and trial-level quality tolerance limits where appropriate.

• Analyze cross-study trends to identify systemic risks, prioritize escalations, and implement preventive improvements while maintaining study teams' accountability for trial-specific execution.

• Govern monitoring oversight standards across centralized, remote, and on-site activities, using monitoring results and emerging quality trends to guide timely action with study leaders and CROs.

• Lead the development and continuous improvement of standard operating procedures, work instructions, job aids, and training materials in alignment with ICH-GCP, including E6(R3) where applicable, regulatory requirements, and internal quality standards.

• Establish clear process ownership and change governance, ensuring operational improvements are proportionate to trial risks, adopted consistently, and measured against defined outcomes.

• Digital Enablement and Operational Excellence: Define and lead the Business Office digital enablement roadmap, prioritizing dashboards, analytics, and automation in collaboration with technology partners.

• Ensure digital solutions incorporate appropriate validation and data protection, and connect insights from monitoring, TMF, and vendor performance to sourcing decisions, contract terms, and operational improvements.

• Develop business cases, prioritize investments according to portfolio needs, and evaluate adoption and measurable operational value.

• Leadership and Cross-Functional Collaboration: Represent Clinical Operations in senior cross-functional governance forums, resolve complex issues with portfolio-wide implications, and align stakeholders around competing priorities.

• Present senior leadership with clear recommendations on material risks, investments, and resource trade-offs, supported by practical options, implications, and accountable next steps.

• Build the Business Office's organizational capabilities and leadership depth by defining team structures, workforce requirements, performance expectations, and development priorities.

• Coach and develop senior professionals and matrixed contributors, strengthen delegation and accountability, and establish succession and knowledge-transfer plans for critical capabilities.

• Foster an inclusive, high-performing team culture grounded in transparency, accountability, empathy, continuous learning, and proactive communication.

Requirements:

• Bachelor's degree in a scientific, business, healthcare, or related discipline. An advanced degree such as an MBA, MS, PhD, or PharmD is preferred.

• 12+ years of progressively responsible experience in clinical operations, clinical business operations, or related functions within biotechnology or pharmaceutical organizations. Candidates should demonstrate sustained leadership of complex clinical operations capabilities, teams, or vendor delivery models across multiple programs.

• Demonstrated experience preparing teams and clinical programs for pivotal inspections and establishing a culture of continuous inspection readiness.

• Extensive expertise in clinical sourcing, CRO and vendor governance, contract negotiations, and investigator site budgeting, with the ability to balance quality, delivery, cost, and strategic partnership considerations.

• Proven ability to establish sourcing and vendor governance strategies, lead complex commercial negotiations, and resolve significant partner performance challenges.

• Strong experience with eTMF governance, inspection readiness, and clinical quality processes, including practical knowledge of ICH-GCP and risk-based quality management.

• Demonstrated ability to establish consistent operational standards across multiple programs, identify systemic risks, and lead sustainable remediation initiatives in partnership with Quality.

• Track record of defining functional strategies, building scalable operating models, and delivering measurable improvements across clinical portfolios.

• Strong strategic judgment and decision-making capabilities, including the ability to navigate ambiguity, manage competing priorities, and influence senior internal and external stakeholders.

• Experience leading and developing senior professionals and matrixed teams, strengthening leadership capabilities, and driving lasting organizational and process improvements.

• Excellent communication, relationship-building, and active listening skills, with the ability to handle challenging discussions with candor, empathy, and professionalism.

• Ability to establish clear accountability, build effective cross-functional partnerships, and lead teams through change while maintaining focus on agreed priorities and outcomes.

Benefits:

• Base salary: $219,000–$329,000 USD per year, depending on relevant skills, experience, education, training, internal equity, and market conditions.

• Eligibility for an annual performance bonus.

• Equity compensation.

• Competitive benefits package.

• Remote working arrangement.

• Opportunity to lead and shape a centralized clinical operations function within an innovative, clinical-stage biotechnology environment.

• Opportunity to influence portfolio-wide quality, inspection readiness, operational performance, and the advancement of clinical programs.