8 jobs at Epizyme

Contribute to the design of clinical trials, including statistical sections of the study protocol, randomization methodology, CDP and writing statistical analysis plans.

Provide strategic direction and oversight of clinical operations activities, including all phases of clinical development: study design, protocol development, site selection, study placement, case report form design, data collection, and drafting of final study reports.

Play a key role in managing the close process, including preparation of general ledger entries, account reconciliations, and detailed account analysis.

Oversight of the Scientific Communication agency responsible for primary content development, author review activities, and submission of abstracts and manuscripts.

The Director provides expertise and advice to determine the activities of projects of high complexity, has achieved a cutting-edge level of expertise, and pioneers projects within the field.

Act as a high-level technical resource to Quality Assurance and customer base for interpretation of policy, review and approval of technical documents, and high-level decision making.

Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards while ensuring compliance to current regulatory guidance and GCPs.

Develop and maintain a comprehensive knowledge of each contract as well as any associated or related contracts. Ensure we are adhering to our obligations and that our partner is adhering to theirs, including resourcing, finances, timelines, reports and information-sharing, disclosures, and decision-making.