Associate Director, Clinical Operations

San Francisco, CA | Clinical Operations

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Job Description

Job Summary

The Associate Director of Clinical Operations (AD of Clin Ops) will report to the Director or Senior Vice President of Global Clinical Operations and work closely with the Clinical Development Scientist lead dedicated to the program.  The AD of Clin Ops will be responsible and accountable for managing the overall clinical operational activities for a program (composed of multiple clinical trials) and may assume responsibility for additional projects/indications as they become available.  The AD of Clin Ops may also provide region-specific operational expertise to other teams within Clovis as necessary.  Clovis Oncology conducts some trials in-house (e.g. early, translational-medicine rich studies) but also works extensively with contract research organizations (CROs) in developing and conducting phase I-IV clinical studies.  The AD of Clin Ops will be responsible for CRO selection and oversite, as well as cross functionally within Clovis to ensure quality conduct of trials and data.  As Clovis continues to grow, the AD of Clin Ops will identify and/or provide input to establish new processes, work instructions, and SOPs to ensure effective and efficient execution of across the clinical operations group.

 

The Clinical Development organization is built around global core project teams, each team comprising of members from key functions.  Each team will have a project team leader and separate project manager.  Each project team has a dedicated clinical operations lead as well as a Clinical Development Scientist lead.  These teams will work on projects ranging from the early phase stage to phase IV programs.  Clovis Oncology operates a matrixed organization, and the AD of Clin Ops must be able to work effectively with functional peers (e.g. Project Management, Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, Legal, etc.) within the project team environment.

Job Responsibilities

  • Responsible and primary point of contact for the operational leadership and strategy of the assigned Program/associated studies:
    • Provide functional expertise for the Clin Ops strategy and tactical implementation of the Program/studies by managing timelines, deliverables, operational team, budget forecasting and management, and vendor oversight
    • Oversight of the operational aspects for the development and delivery of: study protocols, informed consents, vendor selection/management, site/country selection, data monitoring/data collection, study plans, quality initiatives, data review, Inspection Readiness
    • Oversee the selection process of CROs/vendors and provide territory-specific expertise/strategy for the Program and other projects as required
    • Manage and drive content, agenda, and discussions at clinical sub-team which are comprised of all functional areas and ensure action items are closed
    • Develop and execute Program/study-specific risk management plans (e.g., milestones, metrics, critical path) ensuring appropriate escalation when required
    • Evaluate study-level issues for broader impact (e.g., cross-study, cross-Program etc.) in a timely fashion and ensure resolution
    • Represent the clinical operations program on various teams and governance bodies as required
    • Use judgement to proactively identify and remediate Program/study issues (able to make recommendations/decisions swiftly and independently and include/communicate to appropriate stakeholders)
    • Line management responsibilities, which includes hiring talent, providing guidance, performance development, coaching and mentoring
    • Ensure effective Program communications to internal and external stakeholders through meetings, presentations, and other methods
    • Provide senior management with timely updates on progress and changes in scope, schedule, and resources across the program
    • Provide contents and present Program progress/issues the Executive Committee Meetings
    •  Evaluate, recommend, and present standard practice and process improvements to Program and/or Clinical Operations leadership to improve efficiency and effectiveness of study initiation and execution
    • Ensure consistency and compliance across Program/studies and collaborate with other Clin Ops leaders to ensure consistency in departmental standards
    • Partner with GCP Compliance Ops and Clinical Quality Assurance to develop the strategic plan for regulatory audits and inspections
    • Participate in resource prioritization to ensure clinical operations strategic goals and milestones are achieved
    • Participate in assessment and recruitment of new Clinical Operations team members
    • Work with senior management to develop and to achieve corporate goals; work with clinical operations staff to achieve the established corporate goals within the expected time frames
    • Work closely with other functions to ensure GXP compliance
  • Working with the Head of Global Clinical Operations to implement and refine the company’s operations strategy
  •  Develop, review, update, and add SOPs as company/situations evolve
  •  Develop and maintain professional relationships with key opinion leaders
  •  Represent the company at meetings with external attendees

 

Skills & Requirements

Qualifications

  • Leadership skills critical; communicates clearly and demonstrates vision and commitment
  • Demonstrated ability to influence and lead others to deliver quality results in a timely manner in both independent and team environments
  • Must think strategically and drive decisions/Program forward with the ability to weigh both the short and long term impact of decisions
  • Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective
  • Able to interact cross-functionally at all levels within Clovis and externally with consultants, vendors, investigators, and study coordinators
  • Capable and enthusiastic about managing and mentoring Clin Ops employees (CRAs, COMs)
  • Financial acumen in creating and managing large clinical program budgets
  • Strong communication skills; verbal, written, and presentation
  •  Highly motivated and enjoys working in a fast paced environment
  • Strong organizational skills and the ability to prioritize and multi-task
  • Positive, flexible, self-starter, able to multi-task, and thrives under pressure
  • Excellent judgment and problem solving skills
  • Flexible as it relates to responsibilities/assignments; job scope/role may evolve as the company grows and matures
  • Capable and willing to operate at all levels within a project, from oversight to hands-on management of day-to-day activities
  • Confident person keen to take on a leadership role within the Ops department
  • Computer proficiency (MS Word, Excel, PowerPoint)

Education and Experience

  • Bachelors/Master’s degree (or equivalent) in a health care of other scientifically-related field
  • 10+ years of related industry experience as a CRA/Manager/Associate Director or related function with increasing responsibility and scope
  • Oncology experience strongly desired
  • Hematology/oncology experience (patients and/or industry) is a definite plus
  • Previous experience in the management/conduct of global oncology clinical trials, particularly in regions specific to Clovis’ development plans
  • Knowledge of GCPs for global compliance
  • Previous supervisory experience

 

Working Conditions

  • Office-based position (San Francisco, CA or Boulder, CO) with some travel (domestic and international)