Associate Director / Director, Early Clinical Development
Company: CS-Bay Therapeutics Inc
Location: Newark, CA
Posted: 2021-09-03
Job reference #: CSBAY202105
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, Early Clinical Development position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, Early Clinical Development will be responsible for providing early clinical study expertise to CS-Bay’s development team, and responsible for the design, execution, and interpretation of studies in early clinical trials. Positions will be filled based on candidate’s level of experience.
Responsibilities:
1. Serve as the clinical point of accountability for the Development Team and responsible for the overall clinical development plans for CS-Bay projects.
2. Ensure studies are designed to meet regulatory, quality, medical, and access goals.
3. Serve as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept Phase I/II.
4. Drive early clinical development strategy.
5. Analyze, interpretate, and act on clinical trial data towards development.
6. Serve as principal functional author for Regulatory submissions, study reports, and publications.
7. Participate in trial design, development strategy, regulatory strategy based on merging data and multi-functional input.
8. Contribute to clinical study reports (CSRs), regulatory reports, briefing books and submission documents.
Qualifications:
1. Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in oncology area.
2. 8+ years of relevant biotechnology or pharmaceutical industry experience.
3. Extensive experience in clinical trial design and execution, biomarker development, and development strategy in pharmaceutical industry.
4. Excellent skills in clinical development strategy including the clinical components of regulatory submission(s).
5. Experience in oncology is required. Experience with immune agonists is highly desirable.
6. Strong leadership, excellent oral and written communication skills, and enthusiasm for contributing in a fast-paced and innovative environment.
7. 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 “CSBAY202105” 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, Early Clinical Development
Company: CS-Bay Therapeutics Inc Location: Newark, CA Posted: 2021-09-03
Job reference #: CSBAY202105
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, Early Clinical Development position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, Early Clinical Development will be responsible for providing early clinical study expertise to CS-Bay’s development team, and responsible for the design, execution, and interpretation of studies in early clinical trials. Positions will be filled based on candidate’s level of experience.
Responsibilities:
1. Serve as the clinical point of accountability for the Development Team and responsible for the overall clinical development plans for CS-Bay projects.
2. Ensure studies are designed to meet regulatory, quality, medical, and access goals.
3. Serve as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept Phase I/II.
4. Drive early clinical development strategy.
5. Analyze, interpretate, and act on clinical trial data towards development.
6. Serve as principal functional author for Regulatory submissions, study reports, and publications.
7. Participate in trial design, development strategy, regulatory strategy based on merging data and multi-functional input.
8. Contribute to clinical study reports (CSRs), regulatory reports, briefing books and submission documents.
Qualifications:
1. Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in oncology area.
2. 8+ years of relevant biotechnology or pharmaceutical industry experience.
3. Extensive experience in clinical trial design and execution, biomarker development, and development strategy in pharmaceutical industry.
4. Excellent skills in clinical development strategy including the clinical components of regulatory submission(s).
5. Experience in oncology is required. Experience with immune agonists is highly desirable.
6. Strong leadership, excellent oral and written communication skills, and enthusiasm for contributing in a fast-paced and innovative environment.
7. Fluency in Mandarin is desirable, but not required.
What We Offer:
CS-Bay Therapeutics Inc. offers a competitive salary and benefits package.