Associate Director / Director, Pre-clinical Pharmacology and Toxicology
Company: CS-Bay Therapeutics Inc
Location: Newark, CA
Posted: 2021-09-03
Job reference #: CSBAY202104
Company Description:
CS-Bay Therapeutics Inc. is a well-funded private biopharmaceutical company located in Newark, California that is dedicated to meet unmet medical needs with innovative therapeutics. Our projects are designed to harness multiple components of the immune system to combat a wide range of cancers. CS-Bay has a robust portfolio of fully-owned, novel drug candidates at various stages of discovery and development.
Job Description:
We are looking for qualified candidates for Associate Director/Director, Pre-clinical Pharmacology and Toxicology position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, Pre-clinical Pharmacology and Toxicology will be responsible for providing non-clinical pharmacology and toxicology expertise to CS-Bay’s development team. The successful candidate will have broad subject expertise including pharmacology, pharmacokinetics and toxicology with extensive experience in design, execution and interpretation of in vitro and in vivo studies. Positions will be filled based on candidate’s level of experience.
Responsibilities:
1. Provide expert scientific leadership in the areas of non-clinical pharmacology, DMPK and toxicology to preclinical discovery project teams, and ensure preclinical packages support clinical development.
2. Collaborate and coordinate with team members across disciplines to drive study design strategies and resourcing.
3. Lead CRO selection & oversight to deliver critical project data through a network of external study providers.
4. Participate in study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports.
5. In partnership with project team, apply understanding of PK/PD and ADME to support compound evaluation.
6. Assist project team in developing clinical PK and PK/PD/pharmacology plan.
7. Design, operationalize and interpret studies to evaluate candidate molecule toxicities, therapeutic index, and overall risk/benefit assessment.
8. Manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/CTA, PIP, CTD, etc.).
Qualifications:
1. Ph.D. in the area of Pharmacology, Pathology or other discipline with appropriate experience / PharmD in Pharmacology or Pharmaceutical Sciences / DVM with appropriate experience.
2. 8+ years of relevant biotechnology or pharmaceutical industry experience.
3. Demonstrated track record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as project team leader or member.
4. Extended experience in successfully selecting and managing CROs to provide high quality, timely and on-budget studies.
5. Experience in oncology is required. Experience with immune agonists is highly desirable.
6. Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA).
7. Strong leadership, excellent oral and written communication skills, and enthusiasm for contributing in a fast-paced and innovative environment.
8. Fluency in Mandarin is desirable, but not required.
What We Offer:
CS-Bay Therapeutics Inc. offers a competitive salary and benefits package.
How to apply
Please send your resume and cover letter to hr.csbay@csbaytherapeutics.com, and include “CSBAY202104” in the subject line.
CS-Bay Therapeutics Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Associate Director / Director, Pre-clinical Pharmacology and Toxicology
Company: CS-Bay Therapeutics Inc Location: Newark, CA Posted: 2021-09-03
Job reference #: CSBAY202104
Company Description:
CS-Bay Therapeutics Inc. is a well-funded private biopharmaceutical company located in Newark, California that is dedicated to meet unmet medical needs with innovative therapeutics. Our projects are designed to harness multiple components of the immune system to combat a wide range of cancers. CS-Bay has a robust portfolio of fully-owned, novel drug candidates at various stages of discovery and development.
Job Description:
We are looking for qualified candidates for Associate Director/Director, Pre-clinical Pharmacology and Toxicology position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, Pre-clinical Pharmacology and Toxicology will be responsible for providing non-clinical pharmacology and toxicology expertise to CS-Bay’s development team. The successful candidate will have broad subject expertise including pharmacology, pharmacokinetics and toxicology with extensive experience in design, execution and interpretation of in vitro and in vivo studies. Positions will be filled based on candidate’s level of experience.
Responsibilities:
1. Provide expert scientific leadership in the areas of non-clinical pharmacology, DMPK and toxicology to preclinical discovery project teams, and ensure preclinical packages support clinical development.
2. Collaborate and coordinate with team members across disciplines to drive study design strategies and resourcing.
3. Lead CRO selection & oversight to deliver critical project data through a network of external study providers.
4. Participate in study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports.
5. In partnership with project team, apply understanding of PK/PD and ADME to support compound evaluation.
6. Assist project team in developing clinical PK and PK/PD/pharmacology plan.
7. Design, operationalize and interpret studies to evaluate candidate molecule toxicities, therapeutic index, and overall risk/benefit assessment.
8. Manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/CTA, PIP, CTD, etc.).
Qualifications:
1. Ph.D. in the area of Pharmacology, Pathology or other discipline with appropriate experience / PharmD in Pharmacology or Pharmaceutical Sciences / DVM with appropriate experience.
2. 8+ years of relevant biotechnology or pharmaceutical industry experience.
3. Demonstrated track record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as project team leader or member.
4. Extended experience in successfully selecting and managing CROs to provide high quality, timely and on-budget studies.
5. Experience in oncology is required. Experience with immune agonists is highly desirable.
6. Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA).
7. Strong leadership, excellent oral and written communication skills, and enthusiasm for contributing in a fast-paced and innovative environment.
8. Fluency in Mandarin is desirable, but not required.
What We Offer:
CS-Bay Therapeutics Inc. offers a competitive salary and benefits package.