Senior Director, Regional Clinical Study Management

General Description: As part of the regional leadership team, provides inspirational leadership, proactive management, and feedback-oriented 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 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 Clinical Study Manager as required. Champions high-impact, cross-departmental teams within and across the region to ensure different perspectives, ideas and expertise are reflected when executing clinical trials Develops, refines, 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 Oversees the planning and management of the assigned clinical studies from feasibility through closeout activities for region, in line with global study timelines. Influences regional leaders to generate, manage, and maintain high quality study start up and recruitment timelines for region and tracks their progress to plan. Shapes and influences strategies to ensure that the clinical studies are operationally feasible in the region, optimizes 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 that refine their templates. Drives a feedback-oriented culture, in which regional study managers are held accountable for effective 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. Understanding the big picture, sets expectations and anticipates and drives 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 Sets clear quality expectations and priorities for the regional study management and strategies to achieve these expectations. 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 the regional leadership to ensure cross-team, site learnings, and best practices are shared, promoting awareness and cross-functional collaborations. 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 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 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. Strategically forecasts regional team resource needs and establishes contingency plans for key resources. Optimizes regional resource utilization over study lifecycle and liaises with functional managers as needed. Supervisory Responsibilities: As part of the regional leadership team: Interviews, line manages, and evaluates performance of regional clinical study managers (rCSMs) Will support regional strategy and provide input on resourcing assignments Provides key input on annual operating plan, headcount, and budget Communicates with FSP partners Inspires individuals across the business unit to perform at their best; encourages others to recognize their contributions toward the success of the business unit and stay motivated Ensures the competencies and skills required for the regional 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. Computer Skills: MS Office, Project Planning Applications Other Qualifications: Proven experience in clinical research including relevant experience as team lead in clinical functions and experience across multiple studies preferred. Travel: Travel might be required as per business need. Education & Experience Required: Bachelor's degree in a scientific or healthcare discipline and 12+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master’s degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr BeOne Medicines Ltd.