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Position:
Director of Toxicology
Employer:
Nura Bio
Description:
Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio’s research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system.
We are seeking a highly experienced and motivated Director of Toxicology to lead and oversee all aspects of nonclinical safety assessment for our drug development programs. The ideal candidate will play a key role in designing, implementing, and interpreting toxicology studies to support regulatory filings and advance our pipeline from preclinical development to clinical trials. This is a hands-on leadership role in a dynamic, fast-paced environment requiring close collaboration with cross-functional teams.
Nura Bio offers a comprehensive generous medical and dental insurance, vision, life and disability insurance, health savings account, flexible savings, and dependent care, 401(k) plan, and highly attractive stock options.
Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!
Please send your CV with a cover letter delineating why you are interested to joinus@nurabio.com Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio’s research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system.
We are seeking a highly experienced and motivated Director of Toxicology to lead and oversee all aspects of nonclinical safety assessment for our drug development programs. The ideal candidate will play a key role in designing, implementing, and interpreting toxicology studies to support regulatory filings and advance our pipeline from preclinical development to clinical trials. This is a hands-on leadership role in a dynamic, fast-paced environment requiring close collaboration with cross-functional teams.
Nura Bio offers a comprehensive generous medical and dental insurance, vision, life and disability insurance, health savings account, flexible savings, and dependent care, 401(k) plan, and highly attractive stock options.
Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!
Please send your CV with a cover letter delineating why you are interested to joinus@nurabio.com.
Qualifications/Experience:
What You Will Do:
The Head (Director) of Toxicology, reporting to Sr. Vice President of Development Sciences, will lead the toxicology function at Nura Bio and oversees toxicity evaluation of small molecule therapeutics in development. This individual will also contribute to discovery pharmaceutics and assist with the selection of development candidates. Specific responsibilities include, but are not limited to the following,
• Develop and execute the toxicology strategy for drug candidates to ensure alignment with program goals and regulatory requirements • Design and manage GLP and non-GLP toxicology studies (e.g., general toxicology, safety pharmacology, reproductive toxicology, genotoxicity, and carcinogenicity studies) in collaboration with Contract Research Organizations (CROs) • Author and review nonclinical sections of regulatory submissions (e.g., INDs, NDAs, CTAs) and respond to regulatory agency inquiries • Work closely with colleagues in discovery research, drug metabolism, pharmacokinetics, CMC and clinical development to integrate safety data into overall program strategies • Provide expert interpretation of toxicology data to assess risks and guide decision-making in preclinical and clinical development • Identify, select, and manage relationships with CROs to ensure high-quality study execution
What You Will Bring:
• Ph.D., D.V.M., or equivalent in toxicology, pharmacology, or a related field; DABT certification preferred • 10+ years of experience in toxicology within the biotech or pharmaceutical industry, including leadership roles • Proven expertise in designing and managing nonclinical toxicology studies to support small molecule drug development • Broad nonclinical subject matter expertise in toxicology, pharmacology, and ADME/PK • Experience working in neurological diseases preferred • Strong knowledge of FDA, EMA, and ICH regulatory guidelines for nonclinical safety assessment • Experience authoring regulatory submissions and interacting with regulatory agencies • Demonstrated ability to work effectively in a cross-functional, fast-paced environment • The ability to manage multiple tasks efficiently, independently, communicate clearly, and build open and collaborative relationships is essential
Location:
South San Francisco, CA
Contact:
joinus@nurabio.com
Post Date:
1/27/2025 3:09:16 PM
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