Clinical Operations Cambridge, Massachusetts
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.
As clinical study lead, manage study execution, including
management and oversight CROs, vendors and consultants that are
involved with the clinical trial.
Establish study milestones and ensure accurate tracking and
reporting of study metrics and timelines.
Ensures risks are proactively identified, managed, and
mitigation strategies implemented
Ensure trial adherence to ICH-GCP, Federal and local regulations
and company specific SOPs.
Oversees investigator recruitment/ selection
Ensure study staff is appropriately trained on relevant
guidelines, regulations and SOPs.
Participate in program strategy meetings, ad hoc clinical
operations’ initiatives and programs.
Contribute to preparation and review of clinical documentation
such as Investigator Brochures, clinical protocols, informed
consents, annual updates to regulatory authorities, and trial
Maintains primary responsibility for the content of and
execution on all study-related operational plans, such as study
operations manuals, vendor manuals, safety plans, project
management plans, communication plans, and quality plans.
Review and provide input on clinical monitoring visit reports
and ensure that all outstanding follow-up items are closed out in a
Tracks study progress ensuring timely data collection,
monitoring and, in collaboration with data management, internal
Ensure Investigational Medicinal Product and clinical trial
supplies are forecast and tracked, interacting with appropriate
functional areas as needed to resolve issues.
Ensure that the Trial Master File (TMF) is set up and maintained
throughout the trial in compliance with ICH/GCP and company SOPs,
including conducting periodic reviews to ensure all appropriate
documents are filed.
Assist with the development of the clinical components of
regulatory submissions including, but not limited to: safety,
interim and final study reports.
Participate and respond to Quality Assurance and/or regulatory
authority inspection audits.
Responsible for ongoing study communication and escalation of
study related issues as required.
In conjunction with legal group, facilitate the development of
clinical trial agreements and other relevant documents.
Contribute to request, creation and review of scope of work and
budgets; participate in vendor performance management and issue
Manage clinical trial budget, providing ongoing financial
reporting and projections to finance.
Reconcile and report vendor and site invoices, payments and
change orders, ensuring accuracy and timely delivery to
Work cross-functionally to ensure clinical program timelines and
goals are met.
Participate in site visits, evaluating CROs/contract monitors
through co-monitoring visits and/or site audits
Provide study-specific mentoring and line management for junior
team members, as appropriate.
Participate in operational improvement initiatives (e.g. SOP
development, training, etc.)
Education & Requirements:
Bachelor’s degree in health sciences or related field.
Minimum of 5+ years’ experience in clinical research with at
least 2 years’ experience in study management.
Experience in management of CROs, vendors and consultants.
Documented training, knowledge and application of current FDA
Regulations, ICH-GCP guidelines in clinical trials required.
Experience developing trial plans including site monitoring,
risk mitigation strategies, trial budgets, site selection and
clinical supply management.
Proficient written and verbal communication skills.
Ability to collaborate effectively with the study team, cross
functional team members and external partners (including
investigator and site staff) using collaborative negotiation
Therapeutic or medical knowledge preferred.
Strong computer skills including knowledge of Excel, Word,
PowerPoint and Outlook.
Position may require some travel.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer
committed to a diverse and dynamic workplace.
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