Clinical Research Scientist/Senior Clinical Research Scientist (Oncology)
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 patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. 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 position is responsible for working with the physicians and cross functional colleagues within Clinical Development to provide clinical research support for programs as assigned.
- Develops protocols and informed consent documents for clinical studies
- Analyzes clinical data and presents findings to clinical team
- Drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, and other documents for FDA/EMA submissions
- Contributes actively in the CSR preparation and finalization
- Monitors, & reviews along with the medical monitor safety and efficacy data in ongoing studies; monitors GCP compliance with help of clinical operations and CRO
- Contributes to the development of CRFs
- Answers along with the medical monitor patient eligibility questions from CRO and site
- May have a leadership role in the matrix teams for assigned compounds
- Develops and maintains relationships with appropriate KOLs, investigators, cooperative groups, and patient advocacies. Serves as first point of contact for medical questions from sites
- Assists and/or writes with clinical abstracts, assists and/or presents data at scientific meetings, SIVs; conducts protocol training
- Participates with clinical operations in the CRO/vendor selection and bidding
- Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development and regulatory requirements
- Acts as the clinical representative in variety of cross-functional teams
Education & Requirements
- Advanced degree in scientific/life-sciences/clinical/nursing field. M.Sc., Ph.D. preferred
- Minimum of 5 years of clinical drug development experience
- Prior drug development experience in oncology is required
- Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment
- Excellent written and oral communication skills
- Strong analytical ability
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.