Associate Director, Biostatistics
4D Molecular Therapeutics
Google Cloud Platform
Senior Director, Head of Feasibility
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $202,200 - $272,200 per year
Job Level
Senior
About the role
- Act as the Regional Strategic Feasibility Lead within Global Clinical Operations, collaborating with the global strategic feasibility lead, study teams, and cross-functional stakeholders
- Deliver data-driven strategic feasibility reports for early to late-stage medicines development
- Provide site identification and recruitment and retention recommendations to ensure successful execution of clinical trials from concept to completion
- Act as the primary point of contact for the Global Strategic Feasibility and Regional Clinical Operations teams for Feasibility and Re-Feasibility activities
- Liaise cross-functionally to expedite and predictively deliver feasibility insights at TA, indication, program, and study levels
- Combine and integrate data from internal stakeholders and external sources to provide feasibility strategies and establish geographic footprints and proposed sites
- Utilize comprehensive data analysis including local treatment standard of care, disease prevalence, drug landscape, and historical trial data to inform protocol development
- Utilize competitive intelligence to develop study startup forecasts, benchmark assumptions, and enrollment plans and maintain patient enrollment forecasts with risk mitigation plans
- Lead design and implementation of study-specific recruitment programs, collaborating with study teams, vendors, and CROs
- Implement creative processes, methodologies, data, and technologies to enhance Feasibility and Study Startup Services and contribute to strategic planning, capability assessments, and training
- Perform root cause analysis and develop mitigation strategies to address study execution and enrollment challenges
- Participate in regional and global projects, representing Clinical Operations and Study Optimization to support BeiGene R&D goals
- Drive high level of ownership and accountability within team and with external stakeholders; Line Manage Country Feasibility and Clinical Trial Diversity teams
Requirements
- Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline
- Minimum of 12 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management and Operations Management
- 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 data interpretation to drive decision making
- Experience managing, influencing, building, and managing relationships with senior partners in conflicting priority environments
- Experience or willingness to learn developing 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
- Microsoft Office Suite
- CTMS applications
- EDC applications
- Analytic tools (e.g. Citeline, Trialtrove)
- Additional feasibility software
- Ability to travel as required
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan
- Commercial roles are eligible to participate in an incentive compensation plan
- All Company employees are eligible for discretionary equity awards
- Opportunity to voluntarily participate in the Employee Stock Purchase Plan
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysisdata interpretationclinical trial managementfeasibility strategiesstudy startup strategiesproject managementbudget managementsite identificationpatient recruitmentoperational plans
Soft skills
collaborationinfluencingrelationship managementaccountabilityownershipcommunicationleadershipproblem-solvingstrategic planningteam management
