Director / Senior Director, Clinical Pharmacology

Clinical Research Cambridge, Massachusetts


Description

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 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.  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. 

Key Responsibilities:

Reporting directly to the Chief Medical Officer, the Director/Senior Director of Clinical Pharmacology will lead and drive the clinical pharmacology and pharmacokinetics activities and initiatives in support of ongoing global trials. This position is a key member of project teams and responsible for development of clinical pharmacology strategies, implementation and execution of clinical pharmacology studies, and the analysis of clinical pharmacokinetic data across multiple programs.

Responsibilities

  • Serve as Epizyme’s clinical pharmacology technical leader in support of clinical phase oncology projects
  • Develop and implement clinical pharmacology strategies to facilitate the progress of programs in all phases of clinical development
  • Establish and meet timelines for clinical pharmacology studies in humans
  • Provide strategic direction and vision on PK/PD modeling to support study designs, compound development plans and regulatory submissions
  • Conduct PK/PD data analysis including advanced population, PK/PD modeling and simulation and/or disease modeling
  • Contribute to the clinical pharmacology sections of relevant documents, such as clinical study protocols, clinical study reports, investigator's brochures, IST’s, summary documents of the eCTD regulatory submissions, and the annual IND updates
  • Play an active role on cross-functional project teams as a clinical pharmacology representative for all projects in clinical evaluation and build the PK team
  • Responsible for interactions with functional groups (clinical research, biostatistics, programming, toxicology, and regulatory affairs) within the company and with regulatory agencies

 

Education and Requirements:

  • PhD or equivalent in Pharmaceutics, Pharmacokinetics or related field
  • Minimum of 10 years pharmaceutical development experience required
  • In-depth knowledge of oncology clinical development, clinical pharmacology, pharmacokinetic/pharmacodynamics and small molecule clinical development experience required
  • Must have experience participating in cross-functional teams and understanding of the oncology therapeutic area
  • Advanced experience in preparation of pharmacokinetic and clinical pharmacology sections for regulatory submission documents (i.e., INDs, NDAs, BLAs, etc.) and experience with direct interactions with regulatory agencies including FDA and EMEA are required
  • Must have experience with one of the following PK/PD software applications: WinNonLin, NONMEM, Clinical Trial Simulator, Adapt, SPLUS, or other relevant ones.
  • Excellent verbal and written communication skills
  • Must be able to work with minimal supervision, set priorities to meet timelines, to motivate others, and to manage budgets

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.