Senior Director, DMPK
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. 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. In addition to our TAZVERIK program, Epizyme has an active research and discovery pipeline, 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 CSO, the Senior Director of DMPK will lead the DMPK group and drive strategic and tactical activities around DMPK, ADME, and PK, PK/PD.
- Partner with project teams from early discovery through clinical development to identify critical ADME/DMPK needs and formulate strategy to address those issues.
- Integrate in vitro and in vivo ADME results to establish best assays to understand and optimize compound properties in hypothesis driven way
- Deliver data on aggressive timelines to guide medicinal chemistry efforts in optimizing PK properties
- Partner with Biology and Clinical Pharmacology to establish and refine PK-PD-efficacy relationships
- Collaborate with Toxicology to select appropriate preclinical toxicology species
- Manage and mentor scientific staff
- Provide detailed supervision of CROs in the execution and design of both standard and novel experiments to understand PK/PD and PK issues
- Write and review documents to enable registration
Education and Requirements
- PhD or equivalent in drug metabolism or related field with 10+ years of direct industry experience
- Proven ability to drive drug discovery projects from early development through candidate selection and IND
- Advanced knowledge of bioanalytics, mechanistic in vitro and in vivo experiments to determine cause of PK issues and scaling preclinical DMPK data to predict human PK and dosing schedules.
- Firm understanding of the role of free drug in PK
- Familiarity with current FDA and EMA guidelines a plus
- Familiarity with clinical PK and outsourcing ADME studies a plus
- Familiarity with PBPK a plus
- Ability to collaborate across disciplines
- Strong organizational skills, superior communication skills (both written and oral), and attention to detail are an absolute must.
- Demonstrated experience in developing and successfully managing Research budgets and contracts.
- Ability to work well under pressure and drive projects that affect critical timelines
Principals only. No recruiters please.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.