Feasibility Lead

This is a fully remote position, open to applicants in Florida, +2 more states.

📋 Description

• Spearhead the strategy for country selection and formulate data-driven insights regarding country mix, site allocation, and enrollment distribution.

• Supervise CRO in the design and implementation of feasibility assessments, which encompass protocol-specific questionnaires, competitive landscape and trial-density analyses, epidemiological reviews, and regulatory timeline mapping.

• Challenge enrollment assumptions by utilizing internal performance metrics, external intelligence, and direct feedback from sites and investigators.

• Create and sustain a detailed site and investigator landscape tailored to specific indications across North America, Europe, Asia-Pacific, and Latin America.

• Direct the identification and qualification of sites in collaboration with CRO partners, converting findings into criteria-based selection recommendations.

• Monitor site performance history, focusing on enrollment rates, data quality, audit history, screen-failure trends, and startup cycle durations.

• Maintain feasibility metrics and enrollment statistics.

• Deliver feasibility insights, trade-offs, recommendations, data limitations, and key risks.

• Act as the primary feasibility contact for assigned programs from concept through to first patient in.

• Oversee feasibility and site intelligence vendors, as well as CRO feasibility teams, including managing scope, quality, timelines, and deliverable evaluations.

• Collaborate with Patient Advocacy and Recruitment on strategies for patient-finding, referral pathways, and site support.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, public health, or a related discipline.

• Over 5 years of clinical operations experience in biotech, pharma, or CRO, with substantial experience in overseeing country and site feasibility.

• Therapeutic expertise: Strong preference for candidates with experience in Immunology (dermatology, GI experience is a plus).

• Proven track record of owning country selection and/or site selection recommendations for global studies, backed by analytical work.

• Strong quantitative abilities—proficient in developing enrollment models and country scorecards in Excel, and adept at using trial-landscape and real-world data platforms (e.g., Citeline/Informa, IQVIA, TriNetX, ClinicalTrials.gov, EU CTIS).

• Familiarity with ICH GCP, global regulatory and startup requirements, as well as country-level submission and approval timelines.

• Exceptional written and verbal communication skills—capable of transforming ambiguous data into coherent, defendable recommendations for a senior audience.

• Ability to juggle multiple studies and adapt to shifting priorities in a dynamic, lean organization.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.