Vice President, Translational Sciences - 2293 job in Cambridge at Editas Medicine

Description

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

• Provide scientific strategy and operation leadership in preclinical development, translational science and research analytical development for gene and cell therapy in ocular, hematology and oncology therapeutic areas
• Accountable for the translational biomarker strategy, bioanalytical assay development and transfer, clinical assay testing and analysis for all gene and cell therapy programs at Editas
• Develop and implement strategic biomarker plans and be responsible for the design, technical oversight, outsourcing, technology transfer, validation, and documentation for Regulatory submissions
• Provide strong scientific oversight of ongoing programs ensuring that robust analytical processes are in place to generate development candidates with the required efficacy and safety profiles that warrant further clinical development
• Maintain a high-quality bioanalytical capability in house, provide appropriate training and mentorship of staff to ensure adherence to quality in process implementation and execution of the studies
• Collaborate with R&D and clinical teams to translate preclinical POC observations into a clinical development plan including patient selection, safety and efficacy endpoints
• Design, execute, interperate and report the drug-related specialty clinical biomarkers of target engagement, PD, efficacy, immunogenicity and safety endpoint to support clinical trial
• Collaborate with the Quality organization to establish and maintain high-quality systems for outsourcing, managing and reporting research & translational bioanalytical methods and studies that meet both regulatory guidelines and industry best practices
• Prepare and review clinical biomarker and testing-related sections of documents for regulatory submission and participate in regulatory agency interaction
• Prepare and review clinical trial site-facing documents including lab manual, patient consent, etc.
• Work effectively with internal multi-disciplinary team members and external partners/CRO to execute programs consistent with Editas strategy, drive and deliver results to agreed timelines
• Provide leadership to the Analytical Review Board to oversee the analytical workflow of project from research to clinical development
• Communicate concepts, strategies and results to various stakeholders within and outside the organization
• Provide support for peer-reviewed publications and patent filings
• Lead a group of ~20 biologists, and develop a highly collaborative team, with an innovative, results-oriented mindset
• Support the CSO as part of the R&D Senior Leadership team, and a member of the Product Development Committee and Science & Technology Committee
• Recruit and develop exceptional talent within the group, and actively enhance the company culture
• Be responsible for the department budget and scientific/personnel management, achievement of corporate goals, as well as mentorship of broader teams across Editas

Requirements

Knowledge, Skills & Capabilities:

• A strong passion and knowledge for all aspects of the technologies & instrumentation utilized to support the translational sciences
• Detailed, practical knowledge of biomarker development and clinical sample testing
• Proven track record in research and development, including knowledge of IND and regulatory filings
• Strong technical background in biochemistry, cell biology and pharmacology
• Excellent leadership skills, including developing talent and promoting effective teamwork
• Ability to excel in cross-functional collaborations both internally and externally with partners
• Ability to think critically, extract and synthesize simple principles from complex datasets, and have rigorous attention to detail

Education & Relevant Work Experience

• The successful candidate will have an MD, MD/PhD or PhD degree, with specialization in an experimental field of study relevant to Editas’ therapeutic focus areas
• He/She will have a minimum of ten years of drug discovery experience in the pharmaceutical and/or biotechnology industry, with a focus on cell and gene therapy or regenerative medicine and a consistent and proven track record of achievement & career progression
• A minimum of ten years of leadership & management experience, building and managing teams effectively and providing clear strategic vision
• Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines
• Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
• Experience working with all levels of management and consulting with key business stakeholders with an ability to influence for greater outcomes
• Strong team player who has excellent verbal and written communication skills and is solution oriented with a customer service approach
• Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors

Benefits

Benefits Summary:

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.