Senior Manager/Associate Director, Medical Affairs Research
Company: Epizyme
Location: Somerville
Posted on: June 18, 2022
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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
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