Senior Director, Clinical Operations – Business & Excellence

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

📋 Description

• Define the strategy for, establish, and direct a centralized Clinical Operations Business Office.

• Integrate inspection readiness into the execution of clinical trials.

• Manage the operating model, governance, roadmap, annual goals, and performance metrics of the Business Office.

• Oversee resource and capability planning, recommending both internal competencies and external service models.

• Supervise clinical sourcing, vendor governance, site contracts and budgets, trial master file operations, standard operating procedures, operational quality, monitoring oversight, risk and issue management, and CAPA follow-through.

• Direct the commercial strategy, complex contracting decisions, negotiations, and escalation procedures with Legal, Procurement, and Finance.

• Manage centralized site contracting and budgeting operations to enhance study startup consistency and speed.

• Establish vendor governance forums, KPIs, service expectations, escalation pathways, and recovery plans.

• Oversee eTMF governance, filing standards, document ownership, completeness, timeliness, data integrity, access, retention, and record retrieval.

• Ensure continuous inspection readiness, TMF health checks, quality metrics, audits, mock inspections, health authority inspections, remediation, and CAPAs.

• Develop portfolio-wide risk-based quality management, critical-to-quality factors, key risk indicators, and trial-level quality tolerance limits.

• Govern monitoring oversight standards for centralized, remote, and on-site monitoring.

• Spearhead the development and harmonization of SOPs, work instructions, job aids, training, and process-change governance in line with ICH-GCP and regulatory requirements.

• Lead the digital enablement roadmap, which includes dashboards, analytics, automation, validation, data protection, business cases, and investment sequencing.

• Act as a senior cross-functional leader among Clinical Development, Quality, Regulatory, Biometrics, Finance, Legal, Procurement, technology partners, study teams, and vendors.

• Enhance organizational capability, define team structures and workforce plans, mentor and develop talent, and create succession and knowledge-transfer plans.

• Cultivate an inclusive, accountable, transparent, empathetic, and high-performing team environment.

⛳️ Requirements

• Bachelor’s degree in a scientific, business, healthcare, or related discipline.

• A minimum of 12 years of progressively responsible experience in clinical operations, clinical business operations, or related roles within biotechnology or pharmaceutical companies.

• Proven leadership in complex clinical operations capabilities, teams, or vendor delivery models across multiple programs.

• Experience in preparing for inspections for pivotal programs and developing team capabilities to maintain inspection readiness consistently.

• Proficient in clinical sourcing, CRO and vendor governance, contract negotiation, and investigator site budgeting.

• Background in setting sourcing and governance strategy, leading complex negotiations, and addressing significant partner-performance issues.

• Familiarity with eTMF governance, inspection readiness, and clinical quality processes.

• Strong understanding of ICH-GCP and practical application of risk-based quality management.

• Capability to establish consistent standards across programs, identify systemic risks, and lead sustainable operational remediation in collaboration with Quality.

• Demonstrated ability to define functional strategy, build scalable operating models, and achieve measurable results across multiple programs.

• Skilled in influencing senior internal and external stakeholders, navigating ambiguity, resolving competing priorities, and exercising sound judgment on portfolio-level decisions.

• Successful experience in leading and developing senior professionals and matrixed teams, enhancing leadership capability, and driving consistent process and organizational change.

• Excellent communication skills, active listening, and the ability to handle challenging conversations with honesty and empathy.

• Advanced degree such as MBA, MS, PhD, or PharmD is preferred.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.

• Equal employment opportunity.