Senior Director, Development Pharmacology & Toxicology

Intellia Therapeutics, Inc.•Cambridge, MA

3d•$272,538 - $333,102•Remote

About The Position

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: The Senior Director of Development Pharmacology & Toxicology provides strategic leadership in establishing and executing pharmacology and toxicology strategies across multiple therapeutic platforms, including nucleic acid, lipid nanoparticle, cell therapy, small and large molecule. This role is accountable for delivering on substantial departmental goals with direct impact on program and corporate objectives. The Senior Director provides platform-level guidance for safety assessment approaches and oversees cross-functional teams to ensure regulatory success across multiple development programs.

Requirements

Comprehensive knowledge of IACUC, GLP, laboratory safety and data integrity standards to anticipate necessary resources
Proficiency with Microsoft Word, Excel, Powerpoint, and MS Project
Experience managing scientific projects in a highly matrixed organization; evidence of collaboration in multidisciplinary environment
Experience managing rodent and large animal (e.g., non-human primate) studies
BS, MS, PhD in pharmacology, toxicology or related field
At least 15 years + BS, 12 yrs + MS, 10 yrs + PhD experience required.
At least 7 years supervisory experience required
Prolonged periods of sitting at a desk and working on a computer

Responsibilities

Establish and direct platform-wide testing strategies across therapeutic modalities, proactively anticipating evolving guidance from FDA, EMA, ICH and other agencies to create innovative approaches for gene editing, nucleic acid, lipid nanoparticle, and AAV products.
Lead development of compliance frameworks for Good Laboratory Practice (GLP) across multiple programs; integrate GMP considerations into nonclinical testing strategies to ensure seamless transition from early to late development.
Guide design and oversee successful execution of critical nonclinical studies, including pivotal GLP toxicology studies in support of program advancement into and through clinical development.
Shape industry best practices through external engagement and influence regulatory thinking around novel therapeutic modalities, positioning the company as a thought leader in the evolving regulatory landscape.
Direct preparation and review of comprehensive regulatory submission packages, making final determinations on nonclinical content strategy for INDs, CTAs, BLAs, and NDAs across multiple programs simultaneously.
Lead cross-functional initiatives with research, clinical development, manufacturing, regulatory affairs, and quality assurance to develop integrated approaches that enhance overall program strategy beyond individual regulatory considerations.
Define strategic integration between Discovery PharmTox and Development PharmTox to ensure cohesive pipeline progression and seamless candidate transition, establishing long-term nonclinical development frameworks.
Establish departmental priorities and resource allocation strategies in partnership with Preclinical Operations leadership to optimize organizational capabilities across the portfolio.
Represent the company in critical regulatory agency interactions, presenting strategic positions at senior levels and negotiating complex scientific and regulatory matters with health authorities globally.
Direct due diligence activities for potential partnerships, in-licensing, or acquisition opportunities, making recommendations that inform corporate development strategy and long-term portfolio planning.
Serve as a key member of the R&D leadership team, contributing to organizational strategy and assuming broader responsibilities for VP, Pharmacology & Toxicology in their absence or upon delegation.
Recruits, interviews, hires, and trains new staff.
Oversees the daily workflow of the department.
Foster a culture of scientific excellence, innovation, and collaboration within the department and across the organization.
Provides constructive and timely performance evaluations.
Handles discipline and termination of employees in accordance with company policy.