Director/Associate Director, GCP Compliance

Location: Cambridge, MA

Job Code:

Reporting to the VP of Clinical Development Operations, the Director/Associate Director, Clinical Compliance will lead the H3 Biomedicine Clinical Compliance function and will work closely with the Clinical Teams and Quality Assurance (Eisai) to manage and support a culture of quality, regulatory compliance, and continuous Good Clinical Practice (GCP) inspection readiness.

This position is responsible for leading the development, implementation and maintenance of a proactive GCP compliance quality management system, including the development of processes and standards, training, risk assessment, and ensuring adherence to regulatory requirements (ICH, FDA, and EMA) and guidelines.  He or she will work to establish a consistent, standardized approach to compliance and collaborate with cross-functional study teams to implement quality by design infrastructure.  This individual will be instrumental in developing a GCP inspection readiness program and will serve as a GCP compliance expert and may serve as a coach and mentor to junior staff.

Principal Duties and Responsibilities

  • Lead the ongoing configuration, implementation, and maintenance of the electronic Trial Master File system in collaboration with the TMF group
  • Lead the development and implementation of internal processes related to GCP and SOPs
  • Serve as subject matter expert concerning GCP and provide quality and compliance guidance to internal clinical personnel; train and mentor staff
  • Perform quality control review of key clinical documents
  • Assess compliance of clinical investigator sites, vendors, study activities, data, reports, and submissions against the International Conference of Harmonization (ICH), applicable government agency regulations/ guidelines, as well as internal policies, procedures and industry standards
  • Lead data integrity processes and assure maintenance of data integrity standards at H3
  • Collaborate with EMEA legal teams in the coordination of General Data Protection Regulation (GDPR) for H3 Biomedicine,
  • Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviation with projects/ products, to appropriate leaders and colleagues
  • Collaborate with relevant internal functions to develop a GCP inspection readiness program; liaise with cross-functional teams to support audit and inspection activities; assist with inspection activities for GCP inspection at company and investigator sites.
  • Develop and deliver GCP and other relevant training

Qualifications

  • A Bachelor’s degree in a scientific discipline or health related field (e.g., nursing, pharmacy, physician’s assistant) with an advanced degree preferred.
  • Candidates should have a minimum of 10+ years of clinical research experience (or equivalent).
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing clinical trial conduct.
  • Very strong verbal, written and presentation skills are required.
  • Experience of leading of a matrixed cross-functional team.
  • Ability to work independently and in a team environment.

About H3 Biomedicine Inc.

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.

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