AD/Director, Clinical Operations
Job Title: Associate Director / Director, Clinical Operations
Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.
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 Head of Clinical Operations, the Director, Clinical Operations will manage the overall execution of assigned clinical programs and will recommend operational strategies and/or make decisions in support of achieving clinical program objectives. The Director, Clinical Operations is accountable for functional management, including collaborating with Head of Clinical Operations to drive best practices, ensuring project and functional objectives are aligned and cascaded to team members.
- Accountable for the operational execution of program-related activities in accordance with the Clinical Development Plan (CDP), and within established budget, timelines and quality standards.
- Contributes to scenario planning, high-level forecasting of timelines, and assessment of program-level feasibility, including estimation and allocation of resources and budget.
- Develop and manage clinical program risk and opportunity management plans to ensure delivery to timelines, budget and quality with efficient resource utilization.
- Tracks program status, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders.
- Ensure program adherence to ICH-GCP, SOPs, all applicable regulations, and aligned with Key Performance Indicators (KPIs).
- Oversee content of and execution on all study-related operational plans, such as project management, communication, vendor oversight, safety and quality plans.
- Establish and monitor appropriate oversight of CROs and external vendors to ensure alignment with program goals and corporate objectives, including periodic review of contracts and scope of work against vendor performance.
- Obtain, evaluate and report on KPI and quality metrics for Quality Management Review.
- Participate in the development of the clinical components of regulatory submissions (e.g. IND, pre-IND, orphan applications, etc.) as needed.
- Participate in and/or lead working groups and/or initiatives within Clinical Development or cross functionally as required.
- Engage appropriately for study related activities associated with regulatory inspections/audits as liaison with Clinical Quality Assurance.
- May interface with key external stakeholders (KOLs, advocacy groups, partners, etc.)
- Facilitate execution of clinical trial agreements and other relevant documents.
- Oversee development of vendor scope of work and budgets.
- Oversee creation and management of program-level budget(s), including forecasting and reporting.
- Participate in vendor or partner joint steering committee teams, as appropriate.
- Brings program leadership to the clinical team by providing program-specific guidance, clinical trial expertise, operational strategy and direction to achieve results.
- Mentors and coaches staff, provides timely feedback to functional managers.
- Resources projects to enable teams to meet deliverables.
- Ensures that employees are appropriately trained and comply with company and regulatory standards.
- Actively participates and contributes to internal and external governance.
- Sponsors, leads and/or participates in critical department or broad organizational, cross-functional initiatives.
Education & Requirements:
- Bachelor’s degree in health sciences or related field.
- Minimum of 13+ years’ experience in clinical research with at least 7 years’ experience in global study management.
- Experience in management and oversight of CROs, vendors, and consultants.
- Experience with managing or mentoring employees directly or indirectly.
- Extensive knowledge and application of current FDA Regulations, ICH-GCP guidelines in clinical trials required.
- Prior regulatory inspection experience preferred
- Experience developing trial plans including site monitoring, risk mitigation strategies, program and trial budgets, site selection and clinical supply management.
- Proficient written and verbal communication skills.
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Therapeutic or medical knowledge preferred.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Position may require some travel.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.