Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy
Jobs / Job page
Associate Director/Director, Toxicology image - Rise Careers
Job details

Associate Director/Director, Toxicology

Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.


We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.


Overview

Overview The Associate Director/Director, Toxicology, is a key member of the preclinical development team, reporting to the Vice President of preclinical development. In this role, you will be accountable for the GLP tox studies that support regulatory filings and exploratory tox studies to support Korro discovery programs. You will also author nonclinical sections in regulatory submission documents, and address regulatory inquiries. Furthermore, you will represent toxicology at cross-functional project teams and design nonclinical safety data package for Korro programs.  


Responsibilities
  • Additional representative responsibilities will include, but not necessarily be limited to, the following:
  • Design, monitor, and report the IND/CTA toxicology enabling studies, including GLP tox, safety phram, genotox studies, etc. 
  • Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and timeline of candidate molecules.
  • Provide strategic direction on toxicology from discovery throughout market application for programs in different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.
  • Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations.
  • Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy.
  • Author nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, and briefing documents).
  • Contribute to issue-resolution teams, driving the scientific approach for toxicology issue resolution.
  • Provide impurity safety assessment in support of CMC manufacturing and/or registration.
  • Contribute to department SOPs and best practice documents.


Qualifications
  • DVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred.
  • 7-10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.
  • Proven track record of successfully leading toxicology programs through various stages of drug development.
  • Experience in toxicology on oligonucleotides, biologics is a plus.
  • Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation.
  • Passion for science with strong strategic thinking, critical thinking, and leadership skills.
  • Agility to adapt to changes and flexibility to work across different time zones.
  • Excellent interpersonal and communication skills.


Benefits:  Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.

Korro Bio Glassdoor Company Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
Korro Bio DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of Korro Bio
Korro Bio CEO photo
Unknown name
Approve of CEO

Average salary estimate

$150000 / YEARLY (est.)
min
max
$120000K
$180000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Associate Director/Director, Toxicology, Korro Bio

At Korro, we are on the cutting edge of biopharmaceutical innovation, and we’re looking for a passionate Associate Director/Director of Toxicology to join our collaborative team in Cambridge, MA. Here at Korro, we focus on developing groundbreaking genetic medicines with our proprietary RNA editing platform, aiming to transform the way we treat both rare and common diseases. As a key member of our preclinical development team, you will play an essential role in guiding toxicology studies that are pivotal for our regulatory submissions and exploratory projects. You'll collaborate with experts across various disciplines, ensuring that our programs are aligned with the latest regulatory standards and innovate approaches. Your role involves not only designing and monitoring GLP toxicology studies but also authoring crucial nonclinical regulatory documentation. We're seeking an individual with a strong background in toxicology, preferably with experience in oligonucleotides or biologics, and a passion for science that drives strategic thinking and leadership. Our values, which emphasize collaboration, kindness, and integrity, define our company culture. If you're looking for a position that allows you to embrace your expertise while redefining the future of genetic medicine, we can’t wait to meet you. Come help us make a lasting impact on human health!

Frequently Asked Questions (FAQs) for Associate Director/Director, Toxicology Role at Korro Bio
What qualifications are required for the Associate Director/Director, Toxicology position at Korro?

To be considered for the Associate Director/Director, Toxicology role at Korro, candidates must hold a DVM, Ph.D., or an equivalent degree in Toxicology or a related field. Additionally, DABT/DACVP certification is preferred. Candidates should also have 7-10 years of experience as a regulatory toxicologist in the pharmaceutical or biotechnology industry. A proven track record of leading toxicology programs through various drug development phases is crucial.

Join Rise to see the full answer
What are the primary responsibilities of the Associate Director/Director, Toxicology at Korro?

The primary responsibilities of the Associate Director/Director, Toxicology at Korro include the design and oversight of IND/CTA toxicology studies, authoring nonclinical sections of regulatory submissions, and representing toxicology at cross-functional project teams. The role involves strategic input on toxicological evaluations and providing guidance on study design and data interpretation, ensuring alignment with company objectives and regulatory standards.

Join Rise to see the full answer
How does the Associate Director/Director, Toxicology contribute to Korro's research and development goals?

The Associate Director/Director, Toxicology plays a vital role in Korro's research and development goals by influencing the overall development strategy of candidate molecules. This position collaborates with various departments, ensuring that toxicology results are integrated into project timelines and strategic planning, ultimately aiding in the advancement of innovative genetic medicines.

Join Rise to see the full answer
What is the work environment like for the Associate Director/Director, Toxicology role at Korro?

Korro prides itself on a collaborative and inclusive work environment. As an Associate Director/Director in Toxicology, you will be working alongside a team of dedicated professionals who share a commitment to innovative science and patient health. The atmosphere is dynamic and flexible, accommodating collaboration across different time zones, which adds to the vibrant company culture.

Join Rise to see the full answer
What benefits does Korro offer to the Associate Director/Director, Toxicology?

Korro offers a competitive compensation package for the Associate Director/Director, Toxicology that includes equity-based compensation along with a comprehensive benefits package. This includes medical, dental, and vision coverage, a 401(k) retirement plan, life insurance, a dependent care flexible spending account, a health savings account, and free parking, reflecting Korro's commitment to employee well-being.

Join Rise to see the full answer
Common Interview Questions for Associate Director/Director, Toxicology
Can you explain your experience with GLP toxicology studies in drug development?

In answering this question, focus on specific examples from your past roles where you've been directly involved in GLP toxicology studies. Detail your responsibilities and highlight how your contributions impacted the overall success of drug development. Emphasize your understanding of GLP regulations and share specific metrics or outcomes that resulted from your efforts.

Join Rise to see the full answer
Describe a challenging toxicology issue you encountered and how you resolved it.

Use the STAR method to outline the situation, task, action, and result. Discuss a specific challenge you faced in toxicology and the steps you took to address it. Emphasize your problem-solving skills and ability to collaborate with other departments, showcasing how your actions led to a successful resolution and informed future projects.

Join Rise to see the full answer
What strategies do you employ to stay updated with regulatory guidelines in toxicology?

Talk about your proactive approach to staying informed, such as subscribing to industry publications, attending conferences, participating in workshops, or being a member of professional organizations. Mention specific sources or networks that you rely on for the latest information and how you apply this knowledge in your work.

Join Rise to see the full answer
How do you approach designing nonclinical safety studies?

Explain your methodology for designing nonclinical safety studies, detailing how you assess the objectives, regulatory requirements, and scientific principles behind the studies. Provide an example of a study you designed and discuss the factors you considered to ensure comprehensive data collection and analysis.

Join Rise to see the full answer
Can you detail your experience with cross-functional collaboration?

Highlight your experience working with different departments such as discovery, bioanalysis, or regulatory affairs. Provide an example of a project where cross-functional collaboration was critical to achieving project goals and how you navigated any challenges that arose, underscoring your ability to communicate effectively.

Join Rise to see the full answer
What role do you believe toxicology plays in the drug development process?

Discuss the critical function that toxicology serves in ensuring the safety and efficacy of therapeutics. Emphasize how toxicological assessments inform decisions throughout the development process, influence regulatory submissions, and ultimately protect patient health, aligning with Korro's mission.

Join Rise to see the full answer
How do you prioritize your workload in a fast-paced environment?

Share your strategies for time management and prioritization, such as methodologies you follow or tools you use to keep track of tasks. Discuss how you've successfully managed competing deadlines in past roles while maintaining high standards of quality in your submissions.

Join Rise to see the full answer
What is your philosophy regarding mentorship and team development?

Emphasize your commitment to mentoring and developing your team. Highlight specific ways you have provided guidance and support to junior team members, such as training programs or collaborative projects. Showcase your belief in fostering an environment where everyone feels valued and empowered.

Join Rise to see the full answer
Describe an instance where you had to present complex toxicology data to a non-scientific audience.

Explain how you simplified complex toxicological concepts and results for your audience, focusing on clarity and engagement. Talk about the tools or methods you used, such as visuals or analogies, and the resulting feedback from the presentation.

Join Rise to see the full answer
How do you ensure compliance with industry standards in your toxicology work?

Discuss your systematic approach to maintaining compliance with GLP regulations and other industry standards. Highlight how you stay updated on any changes and how you implement best practices in your work to ensure that all studies meet the required guidelines for regulatory submissions.

Join Rise to see the full answer
MATCH
Calculating your matching score...
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
December 20, 2024

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!