BeOne Medicines
Associate Director, Regional Clinical Study Management
Remote (US) · Director
Sponsorship not specified$143k-$193kDetected 14 days ago
GCPData AnalysisLeadershipCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsMicrosoft Office
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odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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About the role
- 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.
- Packages may vary by location due to differences in the cost of labor.
Responsibilities
- 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.
- Drives deliverables regionally for trial or portfolio.
- 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.
- Develops and articulates regional goals, inspiring performance across teams, and develops cross-functional strategies that lead to study success.
- 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.
- 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.
- 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.
- Anticipates and manages the trial data collection process for the region, drives data entry and query resolution.
Requirements
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Travel might be required as per business need.
- Acts as regional lead (if needed) for one or multiple studies across an indication or across a program as required.
- Contributes to the development of regional tools and leads the development of work instructions and SOPs as required.
- 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.
- Provides regional input on global study plans as required.
- 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
- Excellent interpersonal skills, strong organizational skills and ability to influence and lead
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
Skills
- MS Office, Project Planning Applications
Compensation
- $143,300.00 - $193,300.00 annually BeOne is committed to fair and equitable compensation practices.
- Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
- The recruiter can share more about the specific salary range for a preferred location during the hiring process.
- Please note that the listed range reflects the base salary or hourly range only.
- Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.
Benefits
- 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
- Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region.
- As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing.
- The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
- 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.
Company info
- We are proud to be an equal opportunity employer.
- 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.
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This listing is sourced directly from BeOne Medicines's careers page and normalized into a canonical job model.