- Location
- Seoul, Korea, Republic of
- Type
- Full-time
- Seniority
- Senior
- Source
- Workday
Description
About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
The Senior Feasibility and Site Engagement Lead will serve as a value-added resource to sites and investigators and support the Company’s Clinical Development Programs. The Senior Feasibility and Site Engagement Lead will be responsible for building and managing relationships with Key Opinion Leaders (KOLs), clinical trial investigators, and research staff to ensure full engagement throughout an asset’s clinical development. They will also work to build relationships, where appropriate, with scientific organizations and academic organizations.
Being regionally based, the primary focus of the Senior Feasibility and Site Engagement Lead role will be to enhance clinical trial protocol designs, feasibility, protocol execution and enrollment through building close relationships with study investigators and research staff in their region. The Senior Feasibility and Site Engagement Lead will work with the clinical investigators and site staff to provide;
education, support patient enrollment and retention initiatives
identify, mitigate, and provide solutions to enrollment hurdles
disseminate investigational product/trial information
provide scientific intelligence and represent company interests.
The Senior Feasibility and Site Engagement Lead, develops relationships with internal cross functional teams members to ensure the delivery of, high-quality feasibility/site identification assessments. Expertise in the region about Standard of Care, disease landscape and competitive intelligence, including but not limited to competing trials, recent or upcoming approvals, prescribing data, insurance claims data, and recruitment capabilities. This includes conducting feasibility outreach and participating in intelligence gathering and risk assessment to coordinate feasibility projects and deliverables. Aligned with global feasibility and the site management team, this position will play a critical role in data-driven strategic design and operational feasibility, site identification, patient recruitment and retention recommendations for early to late-stage assets development across global clinical operations (GCO) at the concept stage through to execution.
Territories for the Senior Feasibility and Site Engagement Lead position will vary as needs arise and develop.
Essential Functions of the job:
Serves as the primary point of contact for feasibility conducted in the region and liaises cross-functionally to enable expedited, predictive delivery at all stages of regional feasibility
Ensures standardization in the use of data, tools, and processes to support quality decision-making at the therapeutic area, disease indication, programs, and study levels during feasibility output
In partnership with internal stakeholders, including regional leaders (e.g., country heads, regional study managers) and site management (e.g., CRAs, trial oversight managers) - combines and integrates data to provide clear recommendations for feasibility
Strengthens data-driven trend analysis, identifies root causes, and provides relevant recommendations across study teams and programs to accelerate study execution
Provides data-driven operational strategy during feasibility analyses, including site identification, patient recruitment and retention recommendations taking into consideration unmet medical needs of the patient population, study, and business priorities.
Collects and analyzes all data (e.g., local standard of care treatment, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to the targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, establish a geographic country footprint and proposed sites for participation in a clinical study.
Uses all competitive intelligence to develop data-driven study startup forecasts, bench-marking assumptions, and accurate enrollment plans.
Develops deep insights, uncovers unmet needs, and collaborates within a global matrix team.
Explains data to facilitates data-driven decision-making processes.
Partners with study design teams on protocol optimization, enabling data-driven approaches to inform decision-making and improve the predictability of execution
Contributes to improvement and implement creative processes, methodologies, data, and technologies to ensure continuous delivery of high quality of feasibility and study startup
Leads and contributes to Strategic planning meetings, regional in-depth capabilities meetings, training calls, kick-off meetings and ongoing team meetings to confirm the adequacy of sites/enrollment and ongoing feasibility support.
Leverages leading industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, startup cycle time, query rate, protocol deviations, and inspection results) to assist project teams with study initiation timeline forecasting.
In collaboration with internal study team and CRO (if applicable), supports the re-forecasting of patient enrollment models to adjust for new environmental influences (e.g., change in drug landscape, protocol amendment, increased screen failure rate).
Determines risks/mitigation for the study feasibility and patient recruitment
Maintains current therapeutic area knowledge and assesses the impact of evolving information on operational strategies.
Exhibits the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment.
Participates in regional and global projects representing Clinical Operations and Study Optimization initiatives to support BeOne’s R&D goals.
Builds and cultivates relationships with disease area experts (KOLs), Clinical Investigators in the disease area, Research sites, and staff and institutions.
Works collaboratively with sites, investigators, disease area experts (KOLs), and cross-functional team members including Operations, Clinical Development, Medical Affairs, Regulatory, Safety and others to ensure successful start-up, enrollment, and completion of BeOne’s clinical trial programs. This will be the primary measure by which the success of this position will be assessed.
Proactively identifies issues and barriers to enrollment and works to develop solutions in a cross-functional manner. Proactively identifies and addresses concerns from sites and patients regarding clinical trial participation. Develops and maintains BeOne’s working relationships with Investigational sites and Investigators
Serves as a resource to provide education as warranted on clinical trial protocols, scientific background related to products, research rationale, and the latest information related to relevant clinical research. Sustains expertise in disease state management, emerging therapies, and the competitive landscape.
Attends relevant national, regional, and international meetings in the therapeutic area, gathering information on developments in the therapeutic area and representing the company as required.
Engages in peer-to-peer discussions with investigators and researchers about trial progress, data, and results
Identifies new sites for consideration and continuously searches for new opportunities
Qualification Required:
Education and Experience Required:
Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* with a minimum of 5-7 years of combined experience in in all aspects of clinical trials and professional knowledge and skills working with oncologic therapeutics
*Exceptions may be made for candidates with appropriate Clinical Operations experience
Supervisory Responsibilities:
Provides performance feedback on team members as required
Oversees training and development of feasibility team members
Drive a high level of ownership and accountability for the feasibility process within cross functional teams
Manage performance deliverables of team members
Computer Skills: All basic Microsoft Office Programs
Other Qualifications:
Experience in clinical trial design, logistics, and evaluation
Knowledge of compliance and regulatory requirements in clinical trials and drug development
Travel: Extensive Local, Regional and International
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
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
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.