Senior Manager, Biostatistics
Gilead Sciences
Google Cloud Platform
Senior Manager / Associate Director, Bioanalytical and Biomarker Sciences
Angitia Biopharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $130,000 - $180,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Serve as BABM expert on cross-functional drug development teams and lead BABM related program(s) and activities
- Lead internal process and procedure setup and develop corresponding SOPs
- Lead and manage BABM data interpretation, and reporting; present bioanalytical results and update BA status to study teams
- Interface with internal study and clinical teams to define and execute BABM strategies
- Write and review relevant sections of study protocols, analysis plans (assay development and validation plans, sample analysis plan), reports (validation report, sample analysis report), Investigator Brochures, documents for IND filings and NDA/BLA submissions
- Select and manage BABM CROs conducting regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker sample analysis
- Monitor BABM CROs process and procedures to ensure their work qualities
Requirements
- Doctor's or Master's degree in chemistry, biology, biochemistry, or related discipline with an emphasis on analytical techniques
- 8+ years of industry work experience in BABM areas
- Expertise and knowledge of laboratory procedures, practices, and applicable SOPs
- Strong working knowledge of regulations, guidelines, standards that guide collection and utilization of non-clinical and clinical samples and data
- Familiarity with regulatory expectations (FDA and EMA) and industry's best practices in BABM method development and validation
- Ability to diagnose and solve complex technical and scientific problems
- Excellent communication skills and organization skills
