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Director, Regional Clinical Study Management Hematology/Oncology

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Posted : Monday, September 02, 2024 06:39 AM

BeiGene 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.
As part of the regional leadership team, provides strategic leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio and may lead a designated therapeutic area or asset Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget May act as regional lead (if needed) for one or multiple studies across an indication or across a program as required.
Leads regional clinical operations teams (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned portfolio of studies.
Ensures alignment of regional resources and deliverables with overall portfolio goals.
Creates an environment that fosters innovation 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: Drives and influences improved standards of quality and efficiency for the region, promoting subject matter, disease area, or asset level expertise.
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.
Collaborates with key stakeholders in the region and provides regular updates on portfolio progress in the region to senior management and Global Study and Program team as required.
Forms high impact, cross-departmental teams within and across the region to ensure different perspectives, ideas and expertise are reflected when executing clinical trials.
Develops and articulates regional goals, inspiring performance across teams, and develops cross-functional strategies that lead to portfolio success.
Displays therapeutic area knowledge and expertise of assigned portfolio and encourages individuals across the region to aspire to develop this expertise.
Timelines, Planning and Execution Study management responsibilities: Oversees the planning and management of the assigned clinical studies from feasibility through closeout activities for region, in line with global study timelines.
Manages regional leaders to generate and maintain high quality study start up and recruitment timelines for region and tracks their progress to plan.
Influences strategies to ensure that the clinical studies are operationally feasible in the region, enhances 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 and works to refine their templates.
Drives a feedback-oriented culture, in which regional study managers are held accountable for coaching and mentoring CRAs to ensure proper study execution at the sites.
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 and influences regional study managers to improve metrics on data entry and query resolution.
As required, oversees the 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.
Engages effectively across regional leadership team to ensure cross-team, site learnings, and best practices are shared, promoting awareness and cross-functional collaborations that support the effectiveness of the organization.
Improves workload management by supporting clinical study managers in setting priorities and by postponing less relevant work Leads the development, optimization and review of work instructions and SOPs as required.
Budget and Resources Study management responsibilities: Demonstrates understanding of the department’s business levers that impact financial goals, and employs that knowledge to make critical business decisions for the department that support the region’s financial goals Works with the sourcing team to strategize on regional study vendor needs.
Works closely with Clinical Business Operation on optimizing efficiency related to investigator fees, site payment issues and patient travel reimbursement activities.
Optimizes 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.
Develops and implements effective coaching and mentoring processes that can be customized to support both junior team and senior team members and supporting their professional development plans.
Conduct performance appraisals for direct reports which includes providing feedback.
**Hematology/Oncology experience preferred.
BeiGene 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 Salary Range: $158,700.
00 - $218,700.
00 annually BeiGene 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.
Packages may vary by location due to differences in the cost of labor.
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.
All Company employees have the opportunity to own shares of BeiGene Ltd.
stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity.
BeiGene 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.

• Phone : NA

• Location : Remote

• Post ID: 9003726588


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