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Clinical Trial Head

Reference Number: 2966
Location: NJ

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Clinical Trial Head.

The Clinical Trial Head is responsible for management of all aspects and ensuring high quality of assigned clinical trials including leading Clinical Trial Team(s) (CTT).  This position conducts required tasks in collaboration with GBMD and other line functions.  The incumbent will be responsible for program level activities as assigned with an entrepreneurial approach which requires the ability to multi-task on a wide spectrum of activities with an overall external focus.

Major tasks and responsibilities will include:

  • Ability to manage phase I-IV clinical trials. Is accountable for the writing of clinical protocols and related documents in collaboration with the GBMD, 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 major local medical organizations to ensure country feedback is adequately integrated into protocol.
  • Supports the medical director in development of effective working relationship with investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.  Contributes to trial-related scientific meetings.  Leads investigators meetings.  Leads protocol training meetings to support local medical organizations in the conduct of regional meetings.  Is 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, report 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 local medical organizations.
  • In collaboration with the GBMD, leads the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
  • Develops clinical outsourcing specifications in cooperation with respective line functions to facilitate bid templates and selection of CROs; manages interface with CROs in cooperation with the Contract Management Department.
  • Is accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology.  Is 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 like Investigators’ Brochures, safety updates, etc.
  • Manages the on-boarding, and training of new staff.  Mentors TA staff.  May serve as faculty member for training programs.
  • Manages third-party Investigator Initiated Trials, regional and locally 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, update databases and manage budget.  Ensures compliance with SOPs, Business Guidance and regulatory requirements.
  • Implements Individual Patient Support Program as assigned.  Manages physician request, provides treatment plan guidance, ensures compliance with SAE reporting, and manages drug supply.
  • Participates in assigned initiatives.
  • May supervise other team members as assigned in collaboration with the GBMD.  Assigns short to mid-term responsibilities.  Identifies training needs to foster high level of performance, support carrier development through quality development plans.  Proactively manages performances issues.  Establishes annual objectives according to GMA priorities.

We seek candidates with the following qualifications:

  • Degree in health or life sciences required.
  • 5+ years of technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
  • Proven ability to work independently, as well as ability to collaborate and work effectively on teams.
  • Ability to lead a multidisciplinary trial team in a complex matrix environment and build effective relationship with stakeholders.
  • Demonstrate effective Project Management skills as well as ability to prioritize based on business need.
  • 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 of hematology/oncology/endocrinology therapeutic area is preferred.
  • Experience developing effective relationships with investigators.


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 2966. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.