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Senior Bioanalytical Director
2 months ago
We are seeking a highly skilled and experienced professional to join our team as a Senior Bioanalytical Director. As a key member of our organization, you will play a critical role in the development and implementation of bioanalytical strategies to support preclinical and clinical development.
Key Responsibilities- Develop and implement bioanalytical strategies to evaluate PK, PD, metabolites, biomarkers, and immunogenicity.
- Provide scientific and technical oversight to facilitate bioanalytical assay design, method development, optimization, validation, and sample analysis.
- Identify new assays and technologies to expand preclinical and clinical analytical capabilities.
- Lead, develop, and train members of the bioanalytical team and plan for resourcing needs.
- Evaluate and review data, protocols, and reports, and ensure completion and maintenance of documentation.
- Contribute to authoring regulatory filings and manuscripts.
- Collaborate with cross-functional team members to provide bioanalytical expertise and advance programs.
- PhD in Cell and/or Molecular Biology, Biochemistry, Immunology, Pharmacology, or related disciplines with 12+ years of relevant experience.
- Track record and expertise with developing bioanalytical assay methods.
- Demonstrated advanced knowledge and technical hands-on experience in bioanalytical and biomarker assays, cell-based assays, ELISA/MSD, ADA, immunohistochemistry, and flow cytometry.
- Direct experience leading teams, managing CROs, and developing and maintaining effective working relationships with key partners.
- Competency with analysis methods and relevant software, including Prism, Excel, statistical analysis, and Benchling (or other ELN).
- Prior experience preparing documentation for regulatory filings and knowledge of regulatory requirements for bioanalytical assays.
- Proven ability to work collaboratively in a cross-functional team and manage concurrent deliverables in a fast-paced, milestone-driven environment.
- Excellent communication and presentation skills.
- Excellent attention to detail and accuracy.
Abdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are committed to advancing novel treatment options that offer new hope to families facing devastating diagnoses. We are seeking talented individuals who share our passion for innovation and our commitment to excellence.
