What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Key Responsibilities & Accountabilities:
- Direct the conduct of all clinical trials.
- Drive the writing/reviewing/approving clinical project deliverables such as investigational product labeling, pharmacy manuals, informed consents, IRB submissions/approvals, site activations, CRFs, DMP, edit checks, safety plan, DMC charter, and close-out plans.
- Implement all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
- Maintain the Clinical Trial Master File in concert with development partners and/or CROs for all Editas Medicine Clinical programs to ensure accuracy and completeness of the documentation.
- Ensure that all sites, CROs, and Editas are "inspection ready".
- Provide oversight of all Contract Research Organizations (CROs).
- Drive study milestones and study metrics.
- Direct the facilitation of confidentiality agreements, study agreements with sites and external vendors.
- Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets.
- Aid in the identification and evaluation of investigators and investigative clinical trial sites and execute/supervise the completion of clinical trial feasibility studies.
- Oversee the clinical trial monitoring activities in accordance with Editas Medicine and ICH/GCP standards and in compliance with the approved monitoring plan and SOPs.
- Provide regular study updates and trial status to the VP, Clinical Science Operations.
Knowledge, Skills & Capabilities:
- A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP)/ ICH is required.
- Experience in Hematology/Oncology, Neurology, Immunology, Ophthalmology and
- Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy.
- Experience with all phases of clinical drug development including global regulatory submissions preferred.
- Strong communication, organizational and interpersonal skills are required.
- Successful work experience in a matrix team environment with cross functional teams is required.
- Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward.
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
Education & Relevant Work Experience:
- A minimum of a Bachelors' Degree is required¸ preferably in a Scientific or Technical Discipline. Advanced degree (MS, RN, PhD or PharmD) is preferred.
- A minimum of 10+ years of experience in the Clinical Research & Development/Clinical Trials environment is required (clinical trial monitoring experience required)
Physical & Travel Requirements:
- Ability to travel up to 20% of time both domestic and international.