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Intellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determin
Job Source: Intellia Therapeutics, Inc.Vertex Pharmaceuticals
Boston, MA, United States
Director, Regulatory Strategy page is loaded Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22162 Job Description The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regio
Job Source: Vertex PharmaceuticalsMeet
Cambridge, MA, United States
Join this company in a pivotal role where your expertise will advance our mission of utilizing innovative science to develop impactful cancer treatments. This position offers the chance to influence and drive regulatory strategies that align with our cutting-edge oncology assets, fostering collaboration with the FDA to expedite the development and
Job Source: MeetKinsley Power Systems
Cambridge, MA, United States
Associate Director, Regulatory Strategy Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bond
Job Source: Kinsley Power SystemsThe Newsome Group
Lexington, MA, United States
The Executive Director will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management. This individual will provide regulatory leadership to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives
Job Source: The Newsome GroupVertex Pharmaceuticals
Boston, MA, United States
Associate Director, Regulatory Strategy page is loaded Associate Director, Regulatory Strategy Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-22153 Job Description The Regulatory Strategy Associate Director will be responsible for overseeing the development of r
Job Source: Vertex PharmaceuticalsProclinical Staffing
Boston, MA, United States
Director of Global Regulatory Strategy - Permanent - Boston, Massachusetts MA Proclinical is seeking an individual experienced in Global Regulatory Strategy. This is a temporary contract position which holds a hybrid working module and is based in Boston, Massachusetts. Primary Responsibilities: This role is perfect for an individual who thrives
Job Source: Proclinical StaffingAgios Pharmaceuticals
Cambridge, MA, United States
Associate Director, Regulatory Strategy Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds
Job Source: Agios PharmaceuticalsCambridge, MA, United States
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just "treat" people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
Intellia is look for a Director, Genotoxicity Regulatory Lead to support the advancement of genome editing products into the clinic. Within this leadership role, you will support the in vivo and cell therapy development programs in genotoxicity strategy and implementation. This is a highly visible leadership position serving on multiple therapeutic program teams supporting regulatory filings and documentation, as well as interacting with health authorities. In this role you will:
Serve as SME for genotoxicity assessment in support of in vivo and cell therapy development program advancement to the clinic
Effectively interact with other functional area experts in a program team environment to develop overall genotoxicity assessment strategy and defend those recommendations to internal governance committees
Partner with toxicology on strategy and guidance for genetic safety assessment for gene editing approaches
Work closely with Genomic Innovation to align on genotox testing strategy for research programs headed to development candidate nomination
Stay current on regulatory requirements for genome editing therapies and assess new technologies
Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs
Partner with computational biology and software engineering on effective approaches for data capture, structuring, analysis and delivery
Partner with regulatory, clinical, and program team leads to support regulatory filings
Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities
Serve as external SME for genotoxicity assessment for CRISPR based products presenting at conferences, interacting with pre-competitive consortia, and supporting and writing manuscripts focused on genotoxicity methods and justification
About You:
The Director, Regulatory Genomics will have demonstrated expertise in regulatory writing and strategy as well as health authority interactions both written and verbal with a focus on genomics and genotoxicity evaluation. Experience in supporting gene editing therapies into the clinic with a focus on genotoxicity is required. Additionally, experience with toxicology, NGS, sequencing methodologies, molecular biology, and gene editing approaches is preferred. PhD with 10 years directly related industry experience.
Experience in writing and documentation to support regulatory filings as well as response to health authority questions and interacting with health authorities.
Meet your future team:
You will be an SME for genotoxicity and gene editing products working closely with Computational Biology, Toxicology, Genomics Innovation and PreClinical Genotox to support the development of genome editing based therapeutics into the clinic. We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials.
In this key leadership role, you will report directly to the Vice President, Genomic Operations who instills a culture of teamwork, respect, inclusion, collaboration, and communication ensuring that each team member strives to reach their professional and personal potential.
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Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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Email Alert for Director, Regulatory Strategy jobs in Cambridge, MA, United States
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