Senior Manager/Associate Director, Medical Affairs Research

Company: Epizyme
Location: Somerville
Posted on: June 18, 2022

Job Description:

DescriptionEpizyme, 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 .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, Medical Affairs, the Medical Affairs Research role will be responsible for activities associated with a variety of medical affairs research programs including but not limited to the end-to-end operation of the Investigator Sponsored Trials (ISTs) program, vendor management for the Expanded Access Program (EAP), as well as a supporting role in Phase IV studies and Registries. While this is an individual contributor role, it is a highly collaborative role that routinely interacts cross functionally with representatives from legal, compliance, clinical, supply, quality, field medical, regulatory, and safety.Key Responsibilities: IST Management: -The role will manage each request for support from receipt confirmation, review meeting management, and decision letters through contracting, milestone management, vendor management for supply, as well as quarterly updates to internal stakeholders. Additionally, the role will communicate with the field medical team and site to ensure adherence to the contractual obligations, e.g., quarterly updates, courtesy review of abstracts and manuscripts.Expanded Access Program Management: -This is primarily a vendor management role, but also includes quarterly eTMF audits as well as management of documentation related to the program, including CDAs, protocol approvals, charter updates, closeout activities, etc.Phase IV Studies/Registries: The role will be responsible for operational leadership in close collaboration with Medical Affairs leadership and other stakeholders as needed.Education and Requirements: Bachelor's Degree with 7+ years of experience within the pharmaceutical, medical device, or healthcare industry 5 years of experience managing investigator sponsored studies or clinical trial management experience (industry or CRO), or program/project management experience. At least 2 years of this experience must be managing investigator sponsored studies. Familiarity with Phase IV studies and Registries is desired Strong project management experience as well as outstanding organizational skills Proficiency with developing slides and/or reports to highlight achievements within areas of responsibility Strategic mind-set committed to understanding the who, what and why before executing any task Drug development knowledge with basic to strong understanding of other functions relevant to the role, which may include: Research, Pre-Clinical Development, Clinical, Commercial and Regulatory Operate daily in a manner consistent with Epizyme's cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused, and resilient High proficiency in Microsoft Office Ability to provide proof of current vaccination from COVID-19Epizyme, Inc. is a vibrant, entrepreneurial equal employment opportunity employer committed to fostering a diverse and dynamic workplace of multi-generational employees with varied life experiences and perspectives. Epizyme is taking a responsible approach to creating environments that allow us to do what we do best- discovery, development, and commercialization of oncology treatments through the utilization of Epigenetics. As part of our commitment to employee health and safety, COVID-19 vaccines are required for all U.S. salaried and hourly employees, as well as all newly hired employees. As part of our commitment to comply with all relevant regulations and guidances, if you are seeking a medical or religious exemption, you may request a reasonable accommodation at any point in the selection process. Supporting medical or religious documentation will be required where applicable. - You may initiate that process by completing our Accommodations for Applicants form. Flexible work from home options available for all roles at Epizyme.

Keywords: Epizyme, Somerville , Senior Manager/Associate Director, Medical Affairs Research, Healthcare , Somerville, Massachusetts