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BeiGene
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.
General Description:
Study management responsibilities:
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.
Line management responsibilities:
Provides leadership, management, and/or mentorship to associate directors, clinical study managers at various levels for assigned portfolio
Collaborates effectively with internal and external stakeholders within the region as well as with global stakeholders to ensure the needs of the business are met.
Drives the overall Clinical Operations strategy for the region and is accountable for performance against key metrics
Drives resourcing and capability development related to regional study management
Ensures alignment of regional resources and deliverables with overall portfolio goals
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
Line management responsibilities:
Ensures team members are trained on and are adhering to required processes and SOPs.
Drives a quality mindset in the regional study management organization and supports the proactive implementation of risk management principles in the regional study management organization.
Sets clear quality expectations for the regional study management organization.
Drives the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work.
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.
Line management responsibilities:
Conducts performance appraisals for direct reports which includes providing feedback
Supports set up of development plans for direct reports
Drives the hiring of new talent into the regional study management organization
Competencies: Leading level
Embraces Change
Communicates Effectively
Drives Excellence
Provides Leadership
Team Player
Mentors
Manages Stakeholders
Strategic Thinker
Creates Innovation
Learning / Growth Mindset
Computer Skills:
MS Office, Project Planning Applications
Other Qualifications:
Bachelor's degree in a scientific or healthcare discipline and 10+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master’s degree in a scientific or healthcare discipline and 7+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.
Solid leadership and extensive experience either as direct line manager (required for those with line management responsibilities) 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 might be required as per business need.
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.
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.
