Senior Director, Clinical Quality Assurance

Quality Assurance Cambridge, Massachusetts


Description

Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.

 

Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.    

 

Reporting to the Executive Director of Quality Assurance, the Senior Director Clinical Quality Assurance will be responsible for leading the Clinical QA function in support of all Epizyme clinical studies. In partnership with key stakeholders across the organization, s/he will be responsible for continuing to strengthen Epizyme’s overall GCP/Quality capabilities and focus.

 

Key Responsibilities: 

  • Lead Clinical QA Function
    • Provides GCP and quality expertise and strategic leadership to drug development programs
    • Manages, provides tactical leadership, guidance, and mentors Clinical QA personnel
    • Provides input to clinical functions (including Clinical Development, Clinical Operations, Clinical Sciences, Data Sciences, Medical Affairs, Medical Directors, and Pharmacovigilance), Non-Clinical, Quality Systems, Regulatory Affairs, and Training to ensure that clinical trial activities sponsored by Epizyme are conducted by CROs in compliance with GCP regulations and internal requirements
    • Lead development of risk based investigator site management program and oversee the conduct or management of relevant site, vendor, and/or process audits including, but not limited to: Clinical Study Reports, Trial Master Files, Informed Consent Forms, Investigator’s Brochures, and Safety Reports
    • Works with internal customers to develop and execute Quality Plans for clinical studies
    • Collaborates with global GxP Vendor Management function in the risk based oversight of clinical vendors
    • Assists in resolving compliance issues at clinical sites, clinical vendors, laboratories and other vendors by providing an assessment of the impact of any deficiencies
    • Supports the development and/or review of audit agendas, audit reports, CAPAs for internal and external audits
    • Implement CAPAs to address critical clinical QA issues
    • Acts as GCP QA Program lead while working with internal customers to ensure compliance issues (scientific misconduct and serious breach) across all clinical activities are addressed
    • Escalates systemic problems and appropriate recommendations/solutions to senior leadership for immediate and long-term resolution
    • Collaborates with internal customers to ensure regulatory filing documents are audited independently (NDA, MAA, etc.)
    • Participates in company preparations for regulatory inspections as the Clinical QA Lead, which may include developing Inspection Readiness Plans, providing strategic direction for Mock Inspections, and follow-up activities for health authority inspections
    • Reviews contracts with clinical vendors and partners to ensure compliance responsibilities are included
  • Supports the development, implementation and maintenance of QA systems and SOPs for GCP compliance including training
  • Interact with interdepartmental teams, clinical CRO’s, contract labs, and regulatory inspectors
  • Acts as an expert GCP consultant to groups within Epizyme organization
  • Acts as a subject matter expert supporting partner due diligence activities
  • Identifies and tracks Key Process Indicators (KPIs) for reporting of Quality Metrics
  • Promote recognition of company clinical quality programs among departments and stakeholders
  • Manages Clinical QA consultants on complex projects
  • Participate in budget forecasting, planning and tracking for clinical QA
  • Maintains relevant knowledge of both local and international GCP requirements and development as they impact Epizyme standards
  • Other assignments as directed by QA management

 

Education & Requirements: 

  • BA/BS required, with a preference in the sciences, nursing or clinical scientific discipline
  • Minimum of 10+ years of experience in pharmaceutical drug development, with the majority in the field of clinical QA (GCP) in the biopharmaceutical industry 
  • Prior leadership success in building and/or leading a QA team is desired
  • Expertise in GCP regulations and guidance for FDA and international agencies including ICH
  • Demonstrated experience with QA in the areas of GVP and GLP is a plus
  • Excels in driving projects forward with acceptance by stakeholders for alignment on quality initiatives
  • Experience with the conduct of oncology clinical trials is strongly preferred
  • Desire to work “hands on” with minimal supervision, setting priorities, meeting timelines, motivating others, and managing projects
  • Superb communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite
  • Demonstrated success negotiating solutions with multiple stakeholders in sometimes high-pressure situations
  • Diplomatically address sensitive issues confidentially and professionally
  • Periodic travel on assignment to investigator sites and CROs (approximately 10-20 % of time)
  • Experience with Microsoft based applications and ability to learn internal computer systems

 

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.