Director/Senior Director, Clinical Operations - 2235
Company: Editas Medicine
Posted on: January 13, 2022
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
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
- 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
- Ensure that all sites, CROs, and Editas are "inspection
- Provide oversight of all Contract Research Organizations
- 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,
- 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
- 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
Keywords: Editas Medicine, Cambridge , Director/Senior Director, Clinical Operations - 2235, Executive , Cambridge, Massachusetts
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