Logo for Intellia Therapeutics, Inc.

Senior Director, Development Pharmacology & Toxicology

Role overview

Qualifications

  • Advanced degree in pharmacology, toxicology, or a related field (BS/MS/PhD) with extensive experience: 15+ years (BS), 12+ years (MS), or 10+ years (PhD)
  • Minimum 7 years of supervisory experience
  • Comprehensive knowledge of IACUC, GLP, laboratory safety and data integrity standards
  • Experience managing scientific projects in a highly matrixed organization with collaboration across multidisciplinary teams

Responsibilities

  • Establish and direct platform-wide testing strategies across therapeutic modalities, anticipating evolving FDA/EMA/ICH guidance to create innovative approaches for gene editing, nucleic acid, lipid nanoparticle, and AAV products
  • Lead development of GLP compliance frameworks across multiple programs and integrate GMP considerations into nonclinical testing 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 clinical development
  • Direct preparation and review of regulatory submission packages, making final determinations on nonclinical content strategy for INDs, CTAs, BLAs, and NDAs across multiple programs

About the company

Intellia Therapeutics, Inc. logo

Intellia Therapeutics, Inc.

Biotechnology

Intellia Therapeutics is a leading genome editing company whose mission is to develop potentially curative gene editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. We are focused on the development of proprietary therapeutics using a recently developed biological tool known as the CRISPR/Cas9 system. The promise of the CRISPR/Cas9 system is the driving force behind the creation of Intellia. Our founders have a shared belief that the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course. This technology offers the potential for us to develop curative therapeutic options for patients with chronic diseases by addressing the underlying cause of the disease. It can bring new hope and cures to people who now have nowhere to turn for help. Our combination of deep scientific expertise and clinical development experience, along with our leading intellectual property portfolio, puts Intellia in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create a new class of therapeutic products. Intellia has the right people, assets and ambitious vision needed to take full advantage of the CRISPR/Cas9 technology’s attributes – high potency, specificity, simplicity of use, broad applicability, and multifunctional programmability – and accelerate the advancement of curative products into the clinic. View our social media community guidelines at https://www.intelliatx.com/terms-and-conditions/ .

Company details

IndustryBiotechnology
Company size501 - 1000

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

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 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.

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.

Supervisory Responsibilities

  • 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.

About You:

  • 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

#LI-JR1

#LI-Remote

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.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $272,538.00 - $333,102.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.

Apply once. Then go straight to the hiring manager.

After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
Unlocked after you apply
·

Director of Global QA (Quality) Related jobs

Other jobs at Intellia Therapeutics, Inc.

Premium

Reach out to the hiring manager directly.

Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

  • Full match report with fit score and gaps
  • Career diagnostics on how recruiters read you
  • Curated company matches and warm intros
  • 48h early access to new roles

Cancel anytime.