[Hiring] Associate Director, Regional Strategic Feasibility @BeiGene

Role Description

As the regional strategic feasibility lead within Global Clinical Operations (GCO), you will play a vital role in collaboration with the global strategic feasibility lead, study teams, and cross-functional stakeholders in the region to deliver data-driven strategic feasibility reports for early to late-stage medicines development. Your responsibilities will encompass site identification and recruitment and retention recommendations, ensuring the successful execution of clinical trials from concept to completion.

Key Responsibilities

• Accountable for the development and implementation of the regional feasibility strategy.
• Collaborate with the global strategic feasibility lead, study teams, and cross-functional stakeholders in the region to deliver strategic feasibility assessments based on comprehensive data analysis.
• Provide crucial insights to inform decision-making for effective protocol design and execution.
• Conduct and ensure the delivery of high-quality feasibility/site identification assessments, including feasibility outreach and participation in intelligence gathering and risk assessment.
• Evaluate regional capabilities to conduct protocols and achieve targeted enrollment goals, aiming for operational excellence.
• Act as a liaison between the global strategic feasibility team and region/country.
• Assist regional study teams in the successful delivery of allocated feasibility studies.
• Ensure adherence to timelines, quality standards, and BeOne's expectations for all studies in scope.
• Coordinate regional Site and Patient engagement activities for TA/Indication/program and Trial in scope.
• Build expertise within the region regarding Standard of Care, disease landscape, and competitive intelligence.
• Stay informed about competing trials, recent or upcoming approvals, prescribing data, insurance claims, and recruitment capabilities.

Essential Functions of the Job

• 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 various levels (TA, indication, program, study).
• Combine and integrate data from internal stakeholders and external sources to provide clear feasibility strategies for site identification, recruitment, and retention.
• Utilize comprehensive data analysis to inform protocol development and establish geographic footprints and proposed sites for participation in clinical studies.
• 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.
• Implement creative processes, methodologies, data, and technologies to enhance the delivery of Feasibility and Study Startup Services.
• Contribute to ongoing strategic planning, capability assessments, and training efforts to ensure successful feasibility support.
• 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 BeOne R&D goals.

Supervisory Responsibilities

• Drive high level of ownership and accountability within team and with external stakeholders.
• Provide mentoring and training to junior members in the team.

Computer Skills

• Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Trialtrove, etc.) and additional feasibility software.

Other Qualifications

• 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 in managing, influencing, building, and managing relationships with senior partners in conflicting priority environments.
• Experience or 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.

Travel

Travel might be required as per business need.

Education/Experience Required

Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline with a minimum of 8 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management, and Operations Management.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$143,300.00 - $193,300.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Benefits

• Medical, Dental, Vision
• 401(k), FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

BeOne does 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 appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Accommodation

Applicants who require reasonable accommodation in the job application process may contact [email protected].