Coherus BioSciences
Director/Sr. Director, PreClinical Development
Redwood City, CA, United States · Director
Sponsorship not specifiedDetected 4403 days ago
GCPProject ManagementBudgetingPharmacologyGMPFDA RegulatoryResearchExperimental DesignAnimal StudiesLeadershipCommunicationWriting
About the role
- Coherus Biosciences, Inc. is focused on delivering high quality biosimilar therapeutics that will expand the access of important medicines to patients worldwide.
- The successful candidate will first and foremost be an accomplished preclinical product developmental scientist.
- Good planning, budgeting and project management and writing skills are a must.
Responsibilities
- Experience in bioanalytical PK and immunogenicity assays to support preclinical and clinical development and in functional bioassays.
- Minimum of 5 years hands-on expertise developing and executing preclinical studies
Requirements
- Provides strategic preclinical expertise to cross-functional project teams as the preclinical representative.
- Demonstrated proficiency in nonclinical study design and management.
- Demonstrated results in preclinical development and a track record of successful IND, NDA, BLA and EMA filings.
- DABT preferred but not required.
- Experience in working with U.S. and European regulatory authorities required.
- Experience with all phases of pre-IND through Phase I/II/III programs and associated regulatory filings.
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