Associate Director, Pharmacology & Toxicology

Company: Intellia Therapeutics
Location: Cambridge
Posted on: May 11, 2022

Job Description:

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 wantall ofour 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:We are looking to hire an Associate Director to serve as functional lead for product development Program Teams. In this role, you will support an expanding development pipeline by providing cross-disciplinary teams with your expertise to advise nonclinical development strategy for novel genome editing products. Setting Pharm/Tox program objectives and collection of appropriate evidence to support those objectives will be among your core responsibilities. You will also have opportunities to lead relevant basic research investigations and contribute to strategic initiatives while gaining broad experience supporting nonclinical development of CRISPR-derived cell therapy and gene editing products. Specific responsibilities are to:Effectively interact with interdisciplinary program teams to recommend the best nonclinical course of action for a given program, and confidently present those recommendations to internal governance committees. Review and align program-related nonclinical testing plans with ICH or other published health authority guidances (e.g., GLP-compliance) as appropriate. Oversee scientific conduct of nonclinical studies including collaborating with Nonclinical Operations to manage external CROs and internal cross-functional interdependencies (e.g., Research, Bioanalytical, TechOps, Quality). Effectively interact with global health authorities in writing and verbally, including pre-submission (e.g., pre-IND and scientific advice) meeting briefing books, discussions, or other agency requests. Succinctly and effectively communicate interpretation of nonclinical studies for regulatory filings, including components for IBs, clinical protocols, INDs and/or CTAs.About You:Our ideal candidates will be enthusiastic, entrepreneurial scientists motivated to shape how gene editing benefits patients. A Ph.D. or equivalent experience in Toxicology or closely related field is required, along with experience in the pharmaceutical industry with a proven track record of conducting nonclinical safety assessment studies. Additional responsibilities may include:

• Contributing to investigative insight to confirm proof-of-mechanism, proof-of-therapeutic concept and prioritize experimental options to guide effective dosing approaches
• Serving as ad hoc subject matter expert to provide input on other programs and studies, including external partnerships and business development opportunities
• Providing mentorship to scientists within and outside of the department and may be responsible for supervision of internal scientific staff or contracted staffMeet your future team:This is an excellent opportunity to join the growing Pharmacology & Toxicology team in a highly collaborative organization. This position reports to the Head of Pharmacology & Toxicology. The Pharm/Tox team at Intellia is a group of scientists with diverse background. You will have the opportunity to shape the regulatory strategy for cell and gene therapy products, incorporating evolving regulatory requirements, and contribute to IND/CTA filings.Our team is based in Cambridge, MA, and hope that you are accessible to the Cambridge area or willing to relocate. If you decide to join us, you can expect to become a highly valued member of a hardworking and collaborative team. We look forward to fostering your skills, learning from your experiences, and building a larger team together to impact patients' lives.#LI-DG1 Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered. 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.

Keywords: Intellia Therapeutics, Cambridge , Associate Director, Pharmacology & Toxicology, Executive , Cambridge, Massachusetts