General Description
As the Head of Site Feasibility and Enablement, Americas within Global Clinical Operations (GCO), you will hold a strategic leadership role responsible for defining and executing the site feasibility and engagement strategy across the clinical development portfolio in the Americas. This role ensures accurate enrollment planning, optimal site selection, increased clinical trial access, and acceleration of activation and enrollment through site partnerships, patient recruitment strategies, and innovative enablement approaches.
Key Responsibilities
- Develop and lead a regional feasibility strategy aligned with portfolio priorities and timelines.
- Oversee country and site feasibility assessments, integrating data analytics, historical performance, and competitive intelligence.
- Ensure feasibility outputs drive robust, evidence‑based site selection decisions.
- Standardize and continuously improve feasibility processes, tools, and governance.
- Utilize comprehensive data analysis to inform protocol development and establish geographic footprints and proposed sites for participation in clinical studies.
- Establish and maintain strategic relationships with key investigative sites, site networks, and KOLs.
- Design and implement site engagement models that develop long‑term partnerships with key investigative sites.
- Lead efforts to expand clinical trial reach to underserved communities.
- Partner with countries in the assigned region to ensure culturally aligned and locally relevant engagement strategies.
- Utilize competitive intelligence data to develop accurate study startup forecasts, benchmark assumptions, and enrollment plans.
- Maintain patient enrollment forecasts strategically, adjusting for new influencing factors and developing risk mitigation plans.
- Lead the design and implementation of study‑specific recruitment programs, collaborating with study teams, vendors, and CROs as needed.
- Implement creative processes, methodologies, data, and technologies to enhance the delivery of feasibility, study startup services, and recruitment and retention strategies.
- Contribute to ongoing strategic planning, capability assessments, and training efforts.
- Perform root cause analysis and develop mitigation strategies to address study execution and enrollment challenges.
- Represent Clinical Operations in regional and global projects to support BeOne R&D goals.
- Drive cross‑functional governance to support site selection, activation, and enrollment execution.
- Line‑manage the Country Feasibility, Clinical Trial Diversity, Site Partnerships, and Patient Recruitment and Retention teams.
Qualifications
- Minimum of 12 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management, and Operations Management; Bachelor’s degree (or equivalent) required; MD preferred.
- Proven experience with trial optimization vendors, tools, and methods.
- Proficiency with software models and database structures.
- Expertise in principles driving country/site identification, feasibility, and study startup strategies.
- Validated experience in data analysis and interpretation to drive informed decision making.
- Experience managing, influencing, building, and maintaining relationships to achieve results with senior partners in conflicting priority environments.
- Willingness to learn how to develop study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives.
- Clinical trial patient and investigator recruitment experience.
- Validated experience in project and budget management.
- Confirmed experience working with global teams.
- Computer skills: Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g., Citeline, Trialtrove), and additional feasibility software.
- Travel may be required as per business need.
Benefits
- Salary Range: $206,200.00 – $276,200.00 annually.
- Bonus and incentive compensation plans for eligible roles.
- Equity participation – discretionary equity awards and Employee Stock Purchase Plan.
- Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
EEO Statement
BeOne is a proud equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by applicable law. All employment is decided on the basis of qualifications, merit, and business need. We welcome applications from individuals who require reasonable accommodation.