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Associate Director Clinical Operations

Reference Number: 3235
Location: NJ

Our client is a global biopharmaceutical company.  They have asked us to assist them in their search for an Associate Director, Clinical Operations.

Major tasks and responsibilities will include:

  • Manages phase I-IV clinical trials including EAP, Compassionate Use and non-interventional studies.
  • Accountable for the writing of clinical protocols and related documents, leads the clinical trial protocol development process; contributes to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtains approval from internal review boards.
  • Collaborates with the Medical Directors and Advisors of the company’s medical organizations to ensure country feedback is adequately integrated into protocol.
  • Supports the GMA medical director in development of effective working relationship with investigators in assigned therapy area to optimize scientific quality of clinical study design, execution, reporting and publication. Contributes to trial-related scientific meetings. Leads investigators meetings and protocol training meetings to support the company’s local medical organizations in the conduct of regional meetings. Accountable for all internal meetings related to the clinical trial. Develops effective working relationships with stakeholders.
  • Leads and matrix manages the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance; chairs CTT meetings, reports study progress and issues with their resolution plan to International Clinical Teams; leads trial level interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and the company’s local medical organizations.
  • Leads the clinical trial data ongoing scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
  • Develops clinical outsourcing specifications incorporation with respective line functions to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Contract Management Department.
  • Accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
  • Contributes to the development of clinical sections of regulatory documents.
  • Manages the on-boarding, and training of new staff.
  • Manages third-party ITT, Regional and Locally Company Sponsored Trials – provides feedback on study proposals, reviews submitted study concepts/protocols for core requirements. Collaborates with local CPOs and regions to track study progress, updates databases and manages budget. Ensure compliance with the company’s SOPs, Business Guidance and regulatory requirements. Experience with cooperative group studies beneficial.
  • Implements Individual Patient Support Program as assigned. Manage physician request, provides treatment plan guidance, ensures compliance with SAE reporting, and manages drug supply.  Must be aware of local regulatory requirements and have the ability to manage Expanded Access programs.
  • Participates in assigned initiatives.
  • Supervises other team members and assigns short to mid-term responsibilities. Identifies training needs to foster high level of performance, supports carrier development through quality development plans. Proactively manages performances issues. Establishes annual objectives according to GMA priorities.

We seek candidates with the following qualifications:

  • A degree in a life sciences or healthcare is required; advanced degree in Sciences preferred.
  • Five years of technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization is required.
  • Must have proven ability to work independently, as well as ability to collaborate and work effectively in teams.
  • Must be able to lead a multidisciplinary trial team in a complex matrix environment and build effective relationship with stakeholders.
  • Must demonstrate effective Project Management skills as well as ability to prioritize based on business need.
  • Must have a thorough knowledge of Good Clinical Practice and clinical trial design.
  • Immediate statistical and regulatory process knowledge required. Experience with complex or randomized studies.
  • Working knowledge hematology/oncology/endocrinology knowledge of therapeutic area is preferred.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3235. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.