Associate Director/Director, Toxicology
AD/ Director, Toxicology
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.
Reporting to the Executive Director, Head of Nonclinical Safety, you will be responsible for conducting, interpreting, and reporting nonclinical animal studies outsourced to contract research organizations (CROs), as well as serving as the Nonclinical Safety representative to internal Epizyme’s multidisciplinary project teams. Expert knowledge of GLP regulations and regulatory guidelines is essential as you will serve as the primary author of the nonclinical sections of both US and international regulatory dossiers supporting clinical trials and eventual marketing applications. The Associate Director/Director is fully accountable for the development and implementation of solutions to complex problems, formulates innovative and creative approaches to solve technical or scientific problems, and is highly sought after for advice on difficult scientific problems.
The Associate Director/Director will develop new approaches and applications of programs and systems to lead processes in a new direction. She/he will align strategic direction with the company portfolio with minimal oversight. The Associate Director/Director will also provide exceptional scientific leadership for Development programs, and independently exercise broad scientific latitude to influence the strategic direction of the Development portfolio.
This position is responsible for conceiving, developing, managing, directing, and coordinating all phases of discovery and development nonclinical safety studies, the incumbent must have a broad knowledge of drug development principles, drug safety testing and regulatory guidelines.
- Serving as the Toxicology representative on multi-functional project teams supporting discovery and development phase projects.
- Developing and executing nonclinical safety programs from discovery through late-stage clinical development. Providing creative approaches to expedite nonclinical development strategies.
- Developing strong knowledge of the basic biology of the intended target of drug candidates to determine potential liabilities associated with target inhibition and subsequent strategies for early safety screening.
- Designing and leading investigative toxicity studies as necessary, depending on project needs.
- Providing creative approaches to expedite nonclinical development strategies.
- Contributing to the overall toxicology strategy for one or several Research and Development programs throughout the drug development lifecycle.
- Interacting with other functional area experts in a project team environment to recommend the best course of action for a given program and defend those recommendations to internal governance committees.
- Scientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies; serve as study monitor and/or peer review pathologist; prepared to support the execution of each study.
- Review study designs and ensure interdependencies (e.g., Bioanalytical, CMC and Quality and Clinical) are aligned with emphasis on the appropriate and efficient evaluation of pathology.
- Represent Epizyme on partnered programs and at external venues such as scientific meetings.
- Succinctly and effectively summarize the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocols.
- Experience in writing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies.
- Applying a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design of appropriate toxicology studies and development plans.
- Contributing to the preparation of high-quality regulatory documents supporting global clinical development and marketing authorizations
- Communicating findings to key stakeholders, both internal and external, and support and advance project goals and objectives.
Education & Requirements
- PhD in toxicology or related discipline, with 10+ years of pharmaceutical experience working on development project teams; or MS with 15+ years of pharmaceutical experience.
- Minimum 5 years’ experience in interpretation of toxicological, pharmacological, and clinical data for determination of HBELs under a competent mentorship.
- Substantial nonclinical development experience at a pharmaceutical or biotechnology company.
- Direct experience in a GLP setting or with Nonclinical Safety Study conduct.
- Experience with authoring nonclinical toxicity risk assessments, and other product risk characterizations/assessments in a pharmaceutical setting.
- A strong working knowledge of US and international regulatory guidelines. Proven competence in advising teams on current nonclinical safety regulatory guidelines and standard practices.
- Familiarity with drug development strategies for both small molecules and biologics.
- Ability to be proficient and work independently in cross-functional team settings, building productive collaborations, managing conflict, multi-tasking, and prioritizing.
- Excellent written and verbal communication skills.
- Knowledge and functional expertise in R&D.
- Board certification is desired (DABT or ERT).
- Ability to develop trust with cross-functional stakeholders and influence without authority.
- Excellent analytical, organizational and communication skills are essential.
- A proven manager who has hired, trained, motivated, facilitated and led teams in a manner that has positively impacted results, culture, and strategic direction.
- Experience in designing/managing all aspects of outsourced nonclinical safety studies, including CRO selection, study design, study monitoring, and interpreting nonclinical toxicology/safety pharmacology studies.
- Experience with direct FDA interactions supporting drug development activities.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.