Senior Director, Clinical Science - 2378
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We are 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 are 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.
- The Senior Director Clinical Science is a responsible member of the compound development team dedicated to the development and execution of one or more complex compound programs.
- Drive the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans.
- Responsible for data review and analysis in conjunction with other clinical team members prior to database locks.
- Ensure ongoing active review of clinical data for trends in safety, effectiveness and adherence to protocol across clinical trial sites.
- Assist with safety monitoring including contribution to the Development Safety Update Report (DSUR), the Periodic Benefit Risk Evaluation Report (PBRER) and the Safety Risk Management Plan for assigned compounds.
- Drive the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required.
- Drive authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
- Actively participate in internal and external scientific meetings
- Generate and evaluate new scientific ideas in the relevant field and indications
- Drive in collaboration with a cross-functional team to the design and implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the Editas Medicine portfolio.
- Develop in collaboration with the Editas Medicine Clinical Development organization and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs.
- Advanced degree (PhD or PharmD) with 10+ years of experience in the Clinical Research & Development/Clinical Trials environment is required with a minimum of 2 years of clinical trial monitoring experience required.
- Ability to travel up to 20% of time both domestic and international.
- A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) 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.
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.