Executive Director, Lifecycle Lead
Kyverna Therapeutics
Director, Bioanalytical and Translational Science
Amylyx Pharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Lead design, development, and implementation of bioanalytical assays (LCMS, ELISA, qPCR, immunogenicity, cell-based biomarker, in vitro biomarker, etc.) to advance preclinical and clinical programs
- Serve as bioanalytical subject matter expert supporting outsourced bioanalytical strategy, operations, and vendor management
- Contribute to multiple drug programs and serve on cross-functional preclinical and clinical drug program teams
- Select and manage vendors, oversee outsourced bioanalytical and biomarker methods, and ensure methods are developed and qualified/validated following FDA and ICH guidelines
- Review and lead bioanalytical MD/MV reports and data summaries and collaborate with nonclinical toxicologists, clinical pharmacologists, and biostatisticians
- Drive PK, PD, and immunogenicity testing strategy and ensure vendor qualification/validation work meets timelines and quality standards
- Participate in planning, reviewing and authoring regulatory and clinical documents, abstracts, posters, protocols, and publications
- Identify and resolve root causes of bioanalytical method issues and manage critical reagent life-cycle
- Prepare and organize data for cross-functional presentation and communicate results to management, collaborators, and at scientific meetings
- Provide bioanalytical expertise for diligence on external assets and potential in-licensing opportunities
- Occasional travel required for collaboration, conferences and vendor oversight/audit; travel to Cambridge, MA office at least 3 times annually
Requirements
- Ph.D. in biology, chemistry or a related field with at least 5 years, or MS with at least 7 years, of relevant scientific and technical experience in pharma/biotech/CRO environment
- At least 2 years’ experience in biotech (non-negotiable)
- Demonstrated experience developing and leading bioanalysis projects in support of preclinical lead nomination and IND-enabling, and clinical phase 1-3 for LCMS, ELISA, RT-qPCR, ADA, cell-based Nab, biomarker assays
- Demonstrated previous bioanalytical method technical expertise in small molecule, anti-sense oligonucleotides, peptides, biologics (expert level preferred in at least 3 of 4)
- Knowledge of preclinical and clinical drug development regulations with expert-level knowledge of the M10 BMV
- Strong knowledge and experience with application of bioanalytical assay development, qualification/validation and sample analysis
- Demonstrated experience with bioanalytical method documentation to support preclinical in vivo and clinical sample analysis
- Experience working in a regulated (GxP) environment preferred but not required
- Experience managing outsourced bioanalytical and biomarker vendor relationships and overseeing vendor deliverables
- Experience preparing and reviewing MD/MV reports and data summaries
- Experience identifying and resolving root causes of bioanalytical method issues; CAPA experience preferred
- Strong interpersonal, communication and presentation skills
- Ability to function in a biotech team environment and collaborate across departments
- Previous experience contributing to regulatory documents and interacting with health authorities
- Willingness and ability to travel up to 20% for vendor site-visits
