Senior Director, Clinical Operations

Alternative Resources Company

Senior Director, Clinical Operations

Senior Director, Clinical Operations
 
The Senior Director of Clinical Operations will lead the strategic planning and oversight of multiple, complex clinical programs in the Oncology area. Reporting to the Vice President of Clinical Operations, this role develops and implements the clinical planning process, as well as maintains oversight of integrated clinical development, including strategy, timelines, risk plans and budget/resources. The Senior Director will have the important role of leading and developing a team of Clinical Operations professionals, aligned therapeutically and by indication. In addition, this position is responsible for collaborative and effective management and communication with and management of multiple, global external vendors and stakeholders (CROs, central labs, IRBs, and other external partners) including at governance forums (Joint Operating Committees, Quarterly Business Reviews). They will promote relationship development both internally across departments and functional groups, and externally with vendors, KOLs, Investigators and Study Coordinators. This role oversees the activities of all clinical trial partners and internal team members and proactively identifies, manages and communicates risks to key stakeholders, peers and senior management.
 
Responsibilities
  • Drives leadership, oversight, strategic and operational support to the Clinical Operations team, including hiring, resource planning, performance management and regular coaching
  • Leads the operational strategy and tactics to develop, execute and deliver clinical studies/programs with a focus on speed, cost and quality
  • Governs alliances with strategic partners, including CROs and other vendors, to ensure operational plans, timelines and budgets are aligned with corporate objectives and standards, as well as program goals
  • Delivers operational leadership and expertise in development of Clinical Development Plans by providing strategic input into long range planning activities within a program (e.g. budget, timeline, feasibility)
  • Leads interdisciplinary activities by coordinating and collaborating with the Development Sub-Team (DST) and/or with CTWG(s) to set goals and timelines, formulates strategies for execution and escalates issues that may jeopardize timelines and deliverables
  • Initiates quality-by-design efforts to proactively identify and manage risks to trial quality and ensure company inspection readiness at all times
  • Maintains awareness of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems and sites
  • Evaluates and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors.
  • Holds accountability for and participates in long-range financial planning by working with Clinical Operations staff and Finance to develop budgets, projections, accruals and track financial status against program-level budget
  • Leads various internal visible cross-functional initiatives and reports out as necessary (e.g. process improvement, new system validation, patient identification)
  • Provides operational leadership for IND, NDA and/or BLA filing activities for assigned program(s) when applicable, including, but not limited to development and oversight of cross-functional database lock activities within timeline; evaluation and if needed, escalation of resource needs both internally and externally with vendor partners; provide leadership of operations team for inspection preparedness
  • Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits; ensuring that the study team operates in a constant state of inspection-readiness and in compliance with FDA, EMA, GCP and ICH guidelines
  • Leads and/or participates in process development and process improvement initiatives
 
Requirements
Minimum Requirements
  • BS Degree in science or a health-related field is required
  • 15+ years of direct clinical trial management experience
  • Demonstrated excellence in team leadership and operational excellence required
  • Able to successfully communicate complex concepts and data to a variety of audiences
  • Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP
  • Registration (BLA/NDA/MAA) submission experience
  • Experience in successful change management including developing the strategy and implementing important, organization wide changes
  • Deep understanding of managing external relationships, specifically with Investigators, advisors, other study personnel, clients and vendors
  • Ability to communicate effectively in a collaborative team environment where results are achieved through influence, cooperation and the incorporation of multiple points of view 
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
 
Preferred Qualifications
  • Scientific expertise in Oncology preferred
  • Advanced degree preferred but not required