Associate Director, Nonclinical Development - Newark, California

Ardelyx is seeking an Associate Director of Nonclinical Development to join its experienced R&D team supporting drug development programs. · Oversee the conduct of nonclinical studies to support Ardelyx programs. · ...

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. · We are looking for exceptional team members who want an active role in bu ...

We are seeking an experienced Nonclinical Development Scientist II/Senior Scientist with a deep understanding of gene therapy and regulatory agency requirements. · ...

We are seeking an experienced Nonclinical Development Scientist II/Senior Scientist with a deep understanding of gene therapy and regulatory agency requirements. The ideal candidate will have preclinical experience in the field of gene therapy and be able to lead the development ...

We are looking for an experienced Nonclinical Development Scientist II/Senior Scientist with a deep understanding of gene therapy and regulatory agency requirements. The ideal candidate will have preclinical experience in the field of gene therapy and be able to lead the developm ...

We are looking for exceptional team members who want an active role in building a rapidly growing clinical stage biotech. · ...

We are looking for an experienced Nonclinical Development Scientist II/Senior Scientist with a deep understanding of gene therapy and regulatory agency requirements. The ideal candidate will have preclinical experience in the field of gene therapy and be able to lead the developm ...

The Associate Director will develop and execute clinical pharmacology strategies and serve as the clinical pharmacology lead providing subject matter expertise on clinical study and development project teams. · Represent Clinical Pharmacology on clinical development and project t ...

The Senior DMPK Director has strong scientific, technical and leadership skills to develop and implement DMPK and modeling & simulation strategies. · Lead the Translational IND- and NDA-enabling ADME work; · Analyze and interpret preclinical pharmacokinetic... · ...

The Associate Clinical Pharmacology and Pharmacometrics Director has strong scientific · technical and leadership skills to contribute to development and implementation of clinical pharmacology · and modeling & simulation strategies to advance drug candidates across various sta ...

The Clinical Pharmacology & Pharmacometrics Director has strong scientific, technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the development. · ...

This role will perform quality review of regulatory documents to ensure content accuracy and consistency. Document scope includes but is not limited to clinical and nonclinical CTD Module 2 summaries, · Ensure compliance with company and industry standards as well as regulatory e ...

BridgeBio is seeking an experienced Director/Sr Director of Clinical Pharmacology to help grow our biologics pipeline, with a primary focus on nonclinical antibody therapeutics. · ...

We are seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role is responsible for ensuring the execution of the regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regul ...

The company is a biopharmaceutical organization situated in the San Francisco Bay Area. They specialize in antibody discovery and engineering. · Dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs responsible for ensuring the execution of regional regula ...

We are seeking a dynamic and experienced Sr. Manager of Regulatory Affairs to ensure the execution of the regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). Provide regulatory support f ...

We are seeking a highly motivated Scientist/Toxicologist to lead investigative safety strategies for small molecule and emerging modalities and work in close collaboration with colleagues across our Research and Development organizations to enable the advancement of portfolio pro ...

The Associate Director Medical Writing is responsible for preparing high-quality medical writing deliverables within one or more program The incumbent will ensure strategically aligned communication points are conveyed in medical writing deliverables and that communication points ...

We are seeking a Senior Program Manager with experience in lyophilized small-molecule products to oversee end-to-end program execution across Clinical, Nonclinical, Regulatory, and CMC functions. · ...

The Associate Director Medical Writing is responsible for preparing high-quality medical writing deliverables within one or more program. · Works with cross functional teams to author regulatory documents (eg, protocols, clinical study reports) · ...