Nonclinical Study Manager and Operations Lead
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 received U.S. FDA approval for the product, TAZVERIK™ (tazemetostat), for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication was approved under accelerated approval based on overall response rate and duration of response. TAZVERIK™ also recently received accelerated approval by the U.S. Food and Drug Administration (FDA) for two distinct follicular lymphoma (FL) indications: 1) adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, and 2) adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.
Continued approval for these indications is contingent upon verification and description of clinical benefit in ongoing confirmatory trials. 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.
This role will have hands-on responsibility for ensuring technical conduct of a wide range of Nonclinical Safety Studies, from discovery through development Projects. The Operation Lead and Study Manager should be an established and outstanding mentor and a role model to other individuals within the organization and manages activities of the toxicology group. Contributes in addition to Nonclinical Safety Study Monitoring the planning, staffing, budgeting and managing expense priorities, and SOP development, archival retention, and process improvements. S/he will take on responsibilities including planning & business process improvement and will partner closely with other cross-functional groups. This position will also be responsible for conceiving, developing, managing, directing, and coordinating activities for study coordination and assist in the development of nonclinical safety studies. The incumbent must have a broad knowledge of drug development principles, drug safety testing and regulatory guidelines. This position will report to the Head of Nonclinical Safety.
- Assists in the development and execution of Nonclinical Safety Programs from Discovery through late stage Clinical Development Programs.
- Participate in discovery and development teams as nonclinical safety representative, as necessary
- May provide strategic advice for drug development programs.
- Represents toxicology group in providing solutions to difficult technical and scientific issues associated with specific projects.
- Participates in the authoring and review of regulatory documents and regulatory responses.
- Manage toxicology contract research organizations (CROs) by maintaining positive relationships with approved vendors and by identifying new labs for potential use. To conduct RFPs as appropriate.
- Design toxicology study protocols, monitor and review studies conducted at CROs, provide integrated data evaluation and interpretation, review and finalize study reports.
- Communicate nonclinical safety data with appropriate perspective to team and management forums within Epizyme and to external partners.
- Identify, conduct or delegate investigative toxicology work, as necessary.
- Demonstrate flexibility, ability to plan nonclinical toxicology programs creatively to enable accelerated program timelines
- Coordinate the timing and execution of Nonclinical Safety studies for multiple programs (test material availability and shipment and preparation of support documents, assay development).
- Evaluate study designs and program plans for technical and operational issues.
- Review study data on an on-going basis during the conduct of Nonclinical Safety studies. Prepare data summaries including graphs of these data for both updates and inclusion in presentations.
- Develop and maintain study plan details (resources, timing, forecasts, auditing, QC, critical phases, budgets, contracts, billing, regulatory submission dates).
- Follow through on regulatory issues pertinent to regulatory approval as needed.
- Contribute to the managing of interactions between Nonclinical Safety, CROs and Study Directors, Consultants, and internal customers/suppliers.
- Write and review departmental SOPs and work practice guidelines as well as train individuals and groups.
- Monitor critical phases at CROs to ensure protocol adherence and compliance with GLP standards.
Education and Requirements
- BS/MS preferred plus a minimum of 3 years of relevant experience, preferably in an industry setting.
- Direct experience in a GLP setting or with Nonclinical Safety Study conduct
- Knowledge and functional expertise in R&D.
- Ability to communicate effectively and develop strong working relations with research, clinical and program management leadership.
- Ability to manage multiple projects simultaneously in a fast-paced work environment.
- Ability to develop trust with cross-functional stakeholders and influence without authority.
- Excellent analytical, organizational and communication skills are essential.
- Periodic travel required
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.