Browse
Employers / Recruiters

Associate Director/Director, Toxicology

korrobio · 30+ days ago
60 First St, Cambridge, MA 02141
$123k+
Estimation
Full-time
Continue
By pressing the button above, you agree to our Terms and Privacy Policy, and agree to receive email job alerts. You can unsubscribe anytime.
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.

Last updated on Dec 18, 2024

See more

About the company

More jobs at korrobio

Analyzing

Cambridge, Massachusetts

 · 

30+ days ago

Cambridge, Massachusetts

 · 

30+ days ago

Cambridge, Massachusetts

 · 

30+ days ago

Cambridge, Massachusetts

 · 

30+ days ago

More jobs like this

Analyzing
Associate Scientist II$83k+
R
rsjdnwc9jel4i3xyjsm3m8vnhrmayk037bphn44zg3i1bl3dcjtqhqlclsisinpr

Green Oaks, Illinois

 · 

30+ days ago

Scientist I$123k+
B
b6jdnwcpcemgg8el3r9winlpunj8hc038b1vkhowrzxn9gitznreodi38t7rirkp

Waltham, Massachusetts

 · 

30+ days ago

Scientist - Nucleic Acid Analytical Development$74k+
3
3djdnw5yqdh8wl3frr5t6561tvvokq01affwpxt3lcutzo4f8yt1aeiy3msk02or

Chesterfield, Missouri

 · 

30+ days ago

Scientific Associate I$108k+
F
fvjdnwvwi7yecmymd9si3it1ointo80348emvd7mgqh749rpbe3n811jnfkeb228

Holly Springs, North Carolina

 · 

30+ days ago

Biochemist 1, Scientific Operations$103k+
M
m9jdnw9bk529dob7b0nhj8hmrmhgxe030ekfy8ww115xk0jkq5bxt25ll3hbstat

San Jose, California

 · 

30+ days ago

Biologist II$24-34 / hour
E
ebjdnwog0k38sqv62sgsaaixilnl7m093e7qt78j2nfx0pp8qywwiasib59did43

North Chicago, Illinois

 · 

30+ days ago

Clinical-Scientific - Bench Scientist Bench Scientist$108k+
7
7fjdnw91pq69jlvngz1gp518iugamw00c66623tmx447r7e3lkr3gqqpqjhpy8mo

Sanford, North Carolina

 · 

30+ days ago

Scientist I$40-45 / hour
4ujdnwqsdebu7m13em5f0pt5dw80o500d7dv9cbq5ebzngb7yk0n43mjtefnbx0d

Ridgefield, Connecticut

 · 

30+ days ago

Senior Associate Scientist$80k+
9
9xjdnwf8nt489qdiu4ab0qq7clsnet01f27n6pjaxju02yq1u697ou3dvfougsq9

Spring House, Pennsylvania

 · 

30+ days ago

Bioprocess Associate$21.50+ / hour
4
40jdnw6odlbv0ngij0mtdaxtr7lp0u0038vzzv5pvuejilhmu0tcn25vrsj5qp5y

East Syracuse, New York

 · 

30+ days ago

Developed by Blake and Linh in the US and Vietnam.
We're interested in hearing what you like and don't like! Live chat with our founder or join our Discord
Changelog
🚀 LaunchpadNov 27
Create a site and sell services based on your resume.
🔥 Job search dashboardNov 13
Revamped job search UI with a sortable grid, live filtering, bookmarks, and application tracking.
🫡 Cover letter instructionsSep 27
New Studio settings give you control over AI output.
✨ Cover Letter StudioAug 9
Automatically generate cover letters for any job.
🎯 Suggested filtersAug 6
Copilot suggests additional filters above the results.
⚡️ Quick applicationsAug 2
Apply to jobs using info from your resume. Initial coverage of ~200k jobs in Spain, Germany, Austria, Switzerland, France, and the Netherlands.
🧠 Job AnalysisJul 12
Have Copilot read job descriptions and extract out key info you want to know. Click "Analyze All" to try it out. Click on the Copilot's gear icon to customize the prompt.
© 2024 RemoteAmbitionAffiliate · Privacy · Terms · Sitemap · Status