Director, Start-up Strategy and Enrollment Performance, Clinical Operations

About the Role

The Director, Start-up Strategy & Enrollment Performance contributes to the strategic and operational leadership across study feasibility, site selection and activation, recruitment strategy, enrollment delivery, and study performance analysis. Serving as a thought partner to the Clinical Operations Study Lead (COSL), this role brings deep content expertise, a strategy- and risk-focused mindset, and strong analytical skills to shape study-specific approaches from start-up through enrollment delivery. The Director develops and then translates strategy into practical study-, country-, and site-level plans, including tactics, metrics, reporting, risk monitoring and oversight methods. This role partners closely with study teams, CROs, vendors, and functional leaders to implement fit-for-purpose strategies, manage specialized vendors, monitor performance, identify risks, and drive timely mitigation and resolution. The Director also builds stakeholder feedback loops, communicates effectively to drive decisions, and creates measurable value through consistent, accountable execution across studies. The Director builds, owns and maintains a scalable, fit-for-purpose operating model for this function.

Responsibilities

• Contribute to the site feasibility, selection and activation strategy; may serve as accountable lead for one or more of these activities depending on study needs and scope
• Develop, achieve endorsement, and own the study recruitment strategy in alignment with study assumptions e.g., scope, timeline, study population, disease landscape, enrollment strategy, and diversity and retention objectives
• Serve as a valued thought partner for the COSL (Clinical Operations Study Lead) on the development of the study enrollment strategy and timeline, including performance assumptions and performance monitoring strategy
• Oversee the collection, analysis and synthesis of available benchmark, historic and ongoing data as it pertains to the relevant strategies
• Translate the recruitment and enrollment strategy into practical study-, country- and site-level plans, tactics, metrics, and performance expectations that support delivery against enrollment targets
• Lead relevant tactic implementation, including ownership of requirements, insourcing vs. outsourcing strategy, and development oversight; may need to lead the creation of tactics/materials in-house
• Accountable to develop, oversee, and deliver performance metrics for assigned remit across study start-up to enrollment; monitor progress via KPIs and dashboards, identify risks and make recommendations to the study team
• Map, analyze and report on the patient funnel from study population to recruitment and prescreening to screening and enrollment; Identify and mitigate bottlenecks
• Manage or oversee central recruitment referrals to sites to ensure optimal volume and progress through central and site pre-screening
• Develop a stakeholder feedback loop to optimize the funnel health and site/patient experience, including appropriate degree of selectivity and efficient progression through steps
• Contribute to and/or own business requirements for metrics, KPIs and dashboards
• Identify, engage, and manage specialized feasibility, recruitment, and/or enrollment vendors, ensuring performance, quality, timelines, budget awareness, reporting, and service delivery align with study needs and organizational expectations
• Influence and align internal and external stakeholders to achieve deliverables in an effective, efficient manner
• Represent study start-up, enrollment and recruitment perspectives in study/program forums and contribute to vendor governance/oversight forums and approaches
• Develop and maintain an operating model for the Start-up Strategy & Enrollment Performance function, including relevant SOPs, work instructions, templates, KPIs, and best practices that enable scalable, fit-for-purpose delivery across studies

Requirements

• Bachelor's degree in life sciences or related field
• 10+ years of experience in clinical operations, patient recruitment, and/or clinical trial optimization within the pharmaceutical, biotech and or CRO/vendor setting, with a strong understanding of the clinical trial lifecycle
• Experience should include exposure to all areas of study/site start-up, recruitment, enrollment, and site performance, with deep expertise and demonstrated success in most if not all these areas
• Highly skilled strategic thinker who can develop and communicate a comprehensive, agile, operational strategy tailored to the specific needs of the study; not simply a set of tactics
• Highly adept at identifying and assessing risks, developing practical solutions, and aligning teams with clarity and confidence
• Strong data-driven mindset, with the ability to translate complex benchmark/historic data, live dashboards, and KPI data into actionable insights
• Strong business and process-driven mindset with the ability to think beyond individual tasks and issues to create a scalable overarching model
• Expert vendor management experience in relevant areas of start-up, recruitment, enrollment; skills should include vendor identification, management, performance oversight, timeline and budget creation, and assessment of ROI
• Excellent knowledge of ICH-GCP, FDA, EMA, applicable regulatory requirements, and quality expectations for clinical trial conduct and patient-facing study activities
• Excellent stakeholder management, communication, negotiation, influencing, analytical, problem-solving, and prioritization skills across internal functions, senior leaders, CROs, vendors, and partners
• Experience managing direct reports preferred
• Ability to thrive in a fast-paced, matrixed, and innovative environment
• Ability to travel occasionally, up to 15%

Pay

The estimated compensation range for this position is $192,000.00 - $204,300.00 per year.