Director/Senior Director, Clinical Program Management

Development & Medical General


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. 

 

Reporting to the Chief of Staff of Clinical Development (COS), the Director/Senior Director, Clinical Program Management will share accountability with the functional heads for the strategic planning and operational excellence in all activities associated with the Clinical development and other cross-functional aspects of assigned development programs. The incumbent will be an experienced program management leader with expertise in solid malignancies, deep program management expertise, and a record of leadership service in a highly dynamic, matrixed environment.

Key Responsibilities:

  • Lead cross-functional Clinical project management of selected programs and assets either in or soon to enter Clinical development.
  • Work with key stakeholders to:
    • Define and manage the Clinical program scope,
    • Create and maintain integrated program plans and timelines,
    • Identify and manage key interdependencies across the larger organization,
    • Identify and manage cross functional program risks with the potential to impact Clinical development and develop mitigation strategies via contingency planning,
    • Participate in Clinical Sub-Team planning and associated activities,
    • Facilitate agendas, minutes, and other Clinical Team deliverables,
    • Identify and develop plans to mitigate resource constraints (i.e. in terms of manpower, budget, and/or core competencies) that have the potential to impact Clinical program progress, and
    • Present status updates to C-Level executive management as needed.
  • Partners with COS and CMO to set high-level strategic goals in alignment with Corporate Objectives.
  • Assist with managing the budget and contracts for the assigned programs.
  • Help drive ongoing program management maturity within the organization and engage in collaborative change management processes.

 

Education and Requirements:

  •  Bachelor's degree in Business or Life Sciences is required. MBA or other relevant advanced degree is strongly preferred.
  • 10 - 15 years in the life sciences industry, including demonstrated experience in the Clinical development and marketing authorization of new human pharmaceutical products.
  • 7+ years project / program management, including leading Teams within a matrixed program environment. Experience with international regulatory approvals is highly preferred.
  • Strong leadership presence and communication skills with an ability to drive decisions through effective interpersonal relationships.
  • High proficiency with the Microsoft Office product suite of software, including MS Project.
  • A high degree of energy, enthusiasm, accuracy, and attention to detail. Must thrive in a fast paced, dynamic environment and be comfortable with a certain amount of ambiguity.

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