Agenus

Associate Director, Clinical Operations

US-MA-Lexington
Job ID
2017-1307
Category
Clinical

Overview

Hierarchal Position

  • the Associate Director of Clinical Operations will report directly to the Executive Director of Global Clinical Operations and is tasked with the following overarching responsibilities:

In collaboration with other Research and Development departments and applicable Business Unit partners,

  • Responsible for the clinical strategic and operational oversight, management, and delivery of one or more clinical development programs in support of Agenus’s development strategy.
  • Authors, provides input, and/or oversees program and/or study level documents.
  • Manages all internal and external team activities including allocated CROs and third-party vendors.
  • Manages financial aspects of assigned clinical program(s) or study(ies).
  • Responsible for strategic initiatives for process and business improvements within Clinical Operations

Responsibilities

Primary Responsibilities:

    • Provides functional input and strategic clinical programs input to Clinical Development Team and Program Management Team as required.
    • Has a thorough understanding of the clinical trial(s) protocol(s) and is able to anticipate potential issues that may arise during the conduct of the trial in close collaboration with CROs
    • Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process.
    • Effectively represents the interests and perspectives of Clinical Operations Department.
    • Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary.
    • Acts as the main escalation point of contact for strategic CRO for the assigned program and the key stakeholder for clinical operations within the Clinical Development organization
    • Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections.

 

Additional Responsibilities:

    • Vendor selection including critical review of contracts, and/or work orders and management of ongoing performance.
    • Collaboration with internal functions to ensure successful implementation of program/stud
    • Conducting study level training
    • Alignment of program for cross-functional team regarding execution
    • Reporting of program / study milestones including mitigation
    • Works closely with Global Development team, finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies; and ensures finances align with agreed development plan, and budget variances are escalated to management as appropriate.     
    • Mentors junior staff
    • May be involved in interviewing, hiring, and training employees
    • Provides feedback on employee performance
    • Collaborates on SOP development and harmonization
    • Identifies or participates in innovative initiatives targeted to improve/revise clinical development processes.

 

Competencies:

  • Ability to oversee and/or manage and communicate effectively with research vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
  • Strong interpersonal skill set necessary to create and maintain external collaborator relationships (e.g. Key Opinion Leaders).
  • Demonstrated ability to prioritize across program / study demands ensuring overall quality.
  • Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
  • Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
  • Ability to work independently, take initiative and complete tasks to deadlines.
  • Ability to work successfully within a cross-functional team.
  • Demonstrated ability to motivate & mentor staff.
  • Excellent written and oral communication skills.
  • Displays a high level of professionalism with internal and external stakeholders.
  • Develops project plan(s) to achieve long-term goals based on higher business level drivers and strategies.

Qualifications

  • Bachelor’s degree is required. Scientific/health care field preferred but not required. Advanced degree preferred.
  • Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical/biotech company or CRO
  • Oncology clinical trials experience (5 years)
  • Previous Phase III and/or Pivotal clinical trials experience a must
  • Global clinical operations research experience is preferred
  • Strong background in project management
  • Experience leading cross-functional teams
  • Detailed knowledge of current regulatory requirements and guidelines governing clinical research
  • Participation in investigational new drug and marketing application review and submission is preferred.
  • Experience managing financial budgets is required

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed