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.
PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION
Language Requirement: Fluent English Required
Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology
Location: Sao Paulo Hybrid
General Description:
As the Regional Strategic Feasibility Lead Senior Manager 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.
Essential Functions:
Strategic Liaison and Cross-functional Coordination:
- 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), ensuring data standardization, tools, and processes for quality decision-making.
Data-Driven Strategic Feasibility:
- Combine and integrate data from internal stakeholders and external sources to provide clear feasibility strategies for site identification, recruitment, and retention at the TA/indication/program level.
- Utilize comprehensive data analysis, including local treatment standard of care, disease prevalence, drug landscape, and historical trial data, to inform protocol development and establish geographic footprints and proposed sites for participation in clinical studies.
- Consider the unique needs of each indication, patient population, study, and business priorities.
Enrollment Forecasting and Risk Mitigation:
- 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 to optimize participant recruitment.
Continuous Improvement and Innovation:
- 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.
- Stay up to date with current therapeutic area knowledge, assessing its impact on operational strategies.
- 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.
Scientific engagement
- Actively drive Site and Patient Engagement activities for assigned TA/Indication/Program and Trials within the region in collaboration with relevant stakeholders.
- Provide CRA Training on Mechanism of Action and disease area
- Support PSSVs and SIVs when applicable, ensuring sites are well-prepared and commitments are secure
Minimum Requirements – Education and Experience:
Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 7 years of combined experience in Medical Affairs (Oncology and hematology field), Feasibility, Clinical Trial Management, Personnel Management and Operations Management.
*Exceptions may be made for candidates with appropriate Clinical Operations experience
Other Experience:
- Experience with trial optimization vendors, tools, and methods.
- Proficiency with software models and database structures.
- Expertise in principles driving country/site identification and feasibility and studying startup strategies.
- Validated data analysis and interpretation experience to drive informed decision-making.
- Tried experience in managing, influencing, building, and managing relationships and achieving results with senior partners in conflicting priority environments.
- Showed 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.
Supervisory Responsibilities:
- Drive high level of ownership and accountability within the team and with external stakeholders
- Provide mentoring and training to junior members of the team
Travel: Travel might be required as per business needs.
Computer Skills:
- Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Trialtrove, etc.) and additional feasibility software
#LI-Remote
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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
We are proud to be an 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.
