Associate Director, Clinical Systems – Strategic Feasibility (Contract)
Location: Fully Remote (U.S.-based)
Travel: ~5% (overnight, for internal meetings/congresses)
Overview
The Associate Director, Clinical Systems (Strategic Feasibility Lead) is responsible for leading end-to-end, data-driven feasibility activities across all phases of clinical development. This role partners closely with cross-functional stakeholders to deliver predictive, standardized feasibility insights that support program and study-level decision-making, optimize trial delivery, and mitigate operational risk.
Key Responsibilities
- Lead and execute the full feasibility lifecycle, including early indication, program-level, and study-level feasibility assessments.
- Develop data-driven country and site identification strategies, enrollment forecasts, recruitment projections, and risk mitigation plans.
- Serve as the primary feasibility point of contact for assigned programs and studies, leading cross-functional collaboration.
- Create and maintain study-level patient enrollment forecasts and feasibility KPIs aligned with approved operational plans.
- Assess and monitor competitive and indication-level risks impacting trial execution.
- Contribute to study operational plans and support trial optimization efforts.
- Drive continuous process improvement at the intersection of data, technology, and clinical development operations.
Qualifications
- Minimum of 5 years of direct feasibility experience within pharma, biotech, or CRO environments.
- Strong understanding of clinical drug development from research through post-marketing (Phase IV), including regulatory and health authority guidelines.
- Proven expertise in data analysis to inform strategic decisions, trial optimization, and operational planning.
- Experience with trial feasibility, protocol optimization, and site intelligence.
- Excellent stakeholder management skills with the ability to influence in a matrixed, global environment.
- Strong written and verbal communication skills in English.
- Proficient with MS Office and relevant clinical systems/tools.
- Not a site management role.
Attributes for Success
- Self-starter who thrives in fast-paced, ambiguous environments.
- Highly analytical with the ability to define and optimize evolving processes.
- Collaborative, globally minded, and effective across cultures and functions.
- Organized, independent, and accountable with strong attention to deadlines.
- Open to feedback and committed to continuous improvement.