CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Senior Director/Executive Director, Head of DMPK

Company: Epizyme, Inc.
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Senior Director/Executive Director, Head of 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/Executive Director of DMPK will lead the DMPK group and drive strategic and tactical activities around DMPK, ADME, and PK, PK/PD. Key Responsibilities

  • 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. You have been redirected to a Epizyme job page

Keywords: Epizyme, Inc., Cambridge , Senior Director/Executive Director, Head of DMPK, Executive , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Project Manager
Description: JOB DESCRIPTIONResponsible for the overall management of current production seating programs and the launch of future programs. Manages periodic engineering changes, customer and supplier related issues, (more...)
Company: Adient plc
Location: Plymouth
Posted on: 04/12/2021

Hourly Manager
Description: Restaurant Hourly Manager br br Do you want to be part of a team whose mission is to Create Great Memories by bringing Family and Friends together Year after year, we strive to be the best Friendly's (more...)
Company: Friendly's
Location: Leominster
Posted on: 04/12/2021

Accounting Manager
Description: Accounting Manager The Opportunity We're looking for an Accounting Manager, working in the Real Estate industry in Boston. Ensures accuracy of property rent rolls, financial reports, budgets and re-projections. (more...)
Company: Professional Staffing Group
Location: Malden
Posted on: 04/12/2021


Assistant Manager D'Angelo's
Description: Description br br Be an Addition by SUB-Attraction br br At D'Angelo's Grilled Sandwiches we are looking for happy people who care about making a difference by creating an atmosphere where passion (more...)
Company: D'Angelo's
Location: Concord
Posted on: 04/12/2021

Senior Manager, Quality Assurance and Regulatory Affairs
Description: Senior Manager, Quality Assurance and Regulatory Affairs Plymouth, MN At Integer, our vision and values are embedded in everything we do -- If you want to work for an organization that values customer (more...)
Company: Integer Holdings Corporation
Location: Plymouth
Posted on: 04/12/2021

Server/Dining Room Care Manager
Description: Overview br It makes me feel good knowing that we make the residents' lives better. We laugh with them, cry with them, sing and dance with them - we brighten their day. Working here is an unbelievable (more...)
Company: Sunrise Senior Living
Location: Plymouth
Posted on: 04/12/2021

Manager, Claims & Fraud Operations, Card Claims, East Providence, RI
Description: The Manager, Claims Fraud Operations leads a team responsible for efforts to detect, prevent and mitigate fraud risks and losses, maximize fraud loss recoveries, and manage the effective and timely (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 04/12/2021

Director of Sales
Description: Director of Sales - Healthcare Analytics/information Services Company Overview Miga Solutions, Inc. www.migasolutions.com is a healthcare information and services company transforming how hospitals (more...)
Company: Miga Solutions
Location: Plymouth
Posted on: 04/12/2021

CONFIGURATION MANAGEMENT SPECIALIST II
Description: Failed loading page
Company: MIKEL INC
Location: Middletown
Posted on: 04/12/2021

Accounting Manager
Description: Accounting Manager The Opportunity We're looking for an Accounting Manager, working in the Real Estate industry in Boston. Ensures accuracy of property rent rolls, financial reports, budgets and re-projections. (more...)
Company: Professional Staffing Group
Location: Salem
Posted on: 04/12/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds