Senior Manager/Associate Director, Clinical Operations
Alcock & McFadden - San Diego, CA

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Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea Biosciences is searching for a Senior Manager/Associate Director, Clinical Operations to join the team.

The Senior Manager/Associate Director, Clinical Operations will be responsible to manage the function of staff, establish and/or update processes, and contribute to continuous quality improvement within and across the functional area groups (Project Management, Site Management, or Regulatory Document Management) of Clinical Operations. Senior Manager/Associate Director will have direct reports within a functional area. The Senior Manager/Associate Director will collaborate with other functional group members within Clinical Operations and with other stakeholders to ensure the quality, efficiency, and timeliness of clinical trials

Responsibilities include:

Management
  • Manages assigned group and/or manages functional area group and ensures appropriate SOPs and processes are in place that meet regulatory requirements, ICH/GCP, and other relevant industry guidelines
  • Responsible for quality control within the assigned functional group to monitor adherence to relevant SOPs and guidelines, and manages direct reports to proactively develop and execute solutions to any identified issues
  • Develops and/or manages budget for functional area group
  • Develops and/or maintains functional department level metrics to monitor efficiency, fiscal adherence and quality oversight, and manage department to meet or exceed corporate goals
  • Develops and maintains resourcing plan for functional group based on project and/or department needs
  • Develops, conducts, and/or direct training opportunities for Clinical Operations staff
  • Guides, mentor and supervises direct reports to ensure quality work is being performed as well as providing growth opportunities
  • Recruits and hires personnel as appropriate, including consultants

    Communication and Coordination
  • Effectively communicates to direct reports as well as internal (e.g., Pharmaceutical Sciences, Regulatory Affairs, Data Management, Biostatistics) departments and external study team members to ensure adequate distribution of information and coordination of activities
  • Leads and/or participates in inter-department and/or cross functional team work groups
  • Acts as vendor relationship manager, providing Company representation and point of escalation for clinical research projects to project scope, deliverables, budget and timelines

    Additional Activities:
  • Ensures internal guidelines and processes (where required) adhere to Ardea's SOPs and ICH guidance
  • Expert knowledge of Ardea SOPs, and within scope of responsibilities actively identify needs for new or revisions of existing operating procedures. Contributes and/or leads development of new or revised clinical SOPs
  • Maintains up-to-date knowledge of clinical principles and theories of drug development and study design in Ardea therapeutic areas
  • May function as a Lead on cross-department Working Groups
  • Actively participates in review of clinical data (i.e., tables, figures, and listings), protocols, CSRs and clinical sections of the Investigators Brochure
  • Ensures functional area group provides required input to INDs/CTAs and NDAs/MAAs, and contribute to their development as appropriate

    Job Requirements

  • Bachelor's Degree or licensed certified health care training or equivalent combination of education and experience
  • In depth understanding and extensive experience working within clinical development as demonstrated by:
  • Minimum of 14 years in the clinical research industry with relevant experience (e.g. leadership role in a relevant functional area other than clinical operations)
  • Minimum of 11 years within clinical operations with a minimum of 7 years within clinical project management role (e.g. project management, clinical study management, etc.)
  • At least 2 years of experience in functional line management
  • Expert knowledge of FDA regulations and ICH guidelines regarding GCPs
  • Excellent communication, presentation, and interpersonal skills
  • Ability to manage directly and indirectly
  • Proven ability to actively lead meetings
  • Strong ability to influence decisions with stakeholders in Clinical Operations and cross-functionally
  • Translates complex and broad concept into plans for action and constructive improvement
  • Manages a wide variety of tasks and projects with increased complexity
  • Ability to integrate responsibilities to produce quality results with a high level of efficiency
  • Strong facilitation, organizational, analytical and time management skills
  • Effectively use automated systems and computerized applications (e.g., Excel, PowerPoint)
  • Demonstrated skills in development of study plans and documentation
  • Demonstrated experience in writing the clinical documents such as protocols, sections of an IB, Clinical Study Reports, IND and/or NDA
  • Ability and willingness to travel

    Apply online at: www.ardeabio.com/careers

  • Alcock & McFadden - 21 months ago - save job