Associate Director, Regional Clinical Study Management

BeiGene, Ltd.; United States; Remote; USD 143,000 - 193,000; Full time

Job summary

BeOne is seeking an experienced regional clinical operations leader to drive portfolio delivery across the region. You will lead the regional team, supervise external partners, and influence study plans from feasibility to closeout while ensuring regulatory readiness and budget adherence.

The role requires strong leadership, strategic thinking, and cross-functional collaboration across CST, regulatory affairs, and medical writing to ensure timely and compliant study execution.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations.
• Preferably master’s degree in a scientific or healthcare discipline with 6+ years of progressive experience.

Responsibilities

• Leads regional clinical operations team and oversees study delivery within budget and timelines.
• Ensures inspection readiness and quality across region; coordinates with CST and Global teams.

Skills

Leadership

Communication

Teamwork

Problem solving

Multitasking

Education

Bachelor's degree in science/healthcare

Master's degree preferred

Tools

MS Office

Project Planning Apps

Job description

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.

General Description

Study management responsibilities: Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget Acts as regional lead (if needed) for one or multiple studies across an indication or across a program as required. Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study or portfolio of studies. Contributes to the development of regional tools and leads the development of work instructions and SOPs as required. Drives deliverables regionally for trial or portfolio.

Essential Functions of the Job

Regional Leadership: Study management responsibilities: Strategically leads the regional clinical operations team effectively across the department, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study. May oversee external vendors involved in study delivery on a regional level. Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required. Oversee the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings. Develops and articulates regional goals, inspiring performance across teams, and develops cross-functional strategies that lead to study success. Displays therapeutic area knowledge and expertise of assigned portfolio.

Timelines, Planning and Execution

Study management responsibilities: Leads or oversees the planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines. Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress. Drives strategy to ensure that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders. Provides regional input on global study plans as required. Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs. Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs. Ensures regional and country information in study systems and tools is entered and up to date. Develops and implements effective coaching and mentoring to CRAs in the region to ensure proper study execution at the sites. May review and sign off monitoring reports. Guides the team responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan. Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region. Anticipates and manages the trial data collection process for the region, drives data entry and query resolution. As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing.

Quality

Study management responsibilities: Anticipates potential concerns and resolves escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads. Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations. Ensures inspection readiness for studies in region at any point in time throughout the study life cycle. As regional study lead, informs Global Clinical Study Manager of any issues arising in the study, evaluates impact and ensures solutions are implemented. As portfolio lead, informs appropriate Global Clinical Study Managers and appropriate Global Clinical Program Leader of regional risk trends arising across portfolio of studies, evaluates impact and ensures solutions are implemented. As study lead, prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate. Engages effectively with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared, promoting awareness and cross-functional collaborations. Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies. Leads the development, optimization and review of work instructions and SOPs as required.

Budget and Resources

Study management responsibilities: Works with the sourcing team to select and manage regional study vendors. Manages and negotiates regional study budgets. Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities. Monitors regional resource utilization over study lifecycle and liaises with functional managers as needed.

Supervisory Responsibilities

Study management responsibilities: Ensures the competencies and skills required for the Clinical team are consistent with the company defined requirements. Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans.

Computer Skills

• MS Office
• Project Planning Applications

Other Qualifications

• Solid leadership and management experience either as direct line manager or as cross functional team lead
• Strong written and verbal communication skills
• Exercises sound judgement and discretion in matters of significance
• Ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Excellent interpersonal skills, strong organizational skills and ability to influence and lead

Travel

Travel: Travel might be required as per business need.

Education Required

Bachelor's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master’s degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.

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

Benefits

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

Equal Opportunity

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.

Accommodation

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].

Company Overview

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 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

For more information, please visit the link to explore job opportunities in China Mainland.

Values

• Patients First
• Driving Excellence
• Bold Ingenuity
• Collaborative Spirit