Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)
Greater San Francisco area
Scientist III/Senior Scientist - Pharmacology & Toxicology
Some assistance available
This individual will develop and implement program-specific nonclinical strategies and represent the nonclinical function and lead various cross-functional efforts with impact across various therapeutic areas and technical platforms. Other responsibilities include:
- Develop and implement program-specific nonclinical strategies
- Design and execute in vitro and in vivo pharmacology, pharmacokinetics and toxicology studies
- Preparation of regulatory documents, INDs, BLAs, etc
- PhD and post-doc experience in toxicology, pharmacology, immunology, or related discipline with 5+ years of pharmaceutical/biotech industry experience. Level based on experience
- Hands-on experience in nonclinical pharmacology, PK and toxicology assessment of biologics and/or genomic medicines
- Deep knowledge of the mechanisms of action of biologics and/or genomic medicines and a strong experience in translating nonclinical findings into clinical PK, efficacy and safety studies.
- Experience in the design, execution, data interpretation and regulatory submissions of in vitro and in vivo pharmacology, pharmacokinetics and toxicology safety studies is a must as well as familiarity with the preparation of regulatory documents, INDs, CTAs, BLAs, and MAAs
- Experience working with US and European regulatory authorities preferred
- Toxicology board certification is desirable
- Travel may be required (up to 10%)
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.