Associate Director/Director Bioanalytics
DEPARTMENT: Discovery
REPORTING TO: Chief Development Officer
LOCATION: Hybrid/Onsite - San Francisco, CA
FULL TIME
Job Summary:
Ouro Medicines is advancing a pipeline of innovative antibody-like therapeutics for immune-mediated diseases, with its lead asset already in clinical development outside the U.S. We are seeking a dedicated Associate Director/Director Bioanalytics to provide pharmacokinetic (PK), immunogenicity (ADA), and bioanalytical expertise to support our therapeutic pipeline.
The ideal candidate will bring substantial experience in the development, troubleshooting, and qualification of bioanalytical assays, as well as managing assay transfer to Contract Research Organizations (CROs). This role involves collaborating with cross-functional teams to drive nonclinical and clinical candidates through various stages of development. Familiarity with biomarker assay implementation for pharmacodynamic studies is a strong plus.
Responsibilities:
- Collaboration with key internal and external stakeholders to select US and/or EU-based Contract Research Organization(s) (CRO) for assay transfer and validation.
- Hands-on experience with large molecule immunoassay techniques (e.g., ELISA, MSD, Gyros) needed for the deployment of PK, and ADA is essential for this position, as is a working knowledge and implementation of neutralization assays.
- Work closely with CROs to ensure timely data transfer supporting assay validation and delivery of key bioanalytical results for early clinical development.
- Working knowledge of FDA and EMA regulatory requirements for assay development and validation, as well as Good Clinical Practice (GCP) and key Clinical Operations, practices, and processes.
- Familiarity with the development of nonclinical PK and ADA assays to support INDs, as well as further development of the assay format for clinical utility.
- Grow and lead a multifaceted bioanalytical development team in a staged manner to support company growth. Handle multiple therapeutic programs at different stages of development in parallel.
- Familiarity with the development of PK and ADA assays that are fit for purpose at different stages of therapeutic development.
- Work closely with colleagues in nonclinical development (e.g., toxicology, pharmacokinetics, and pharmacology) and clinical pharmacology to interpret and integrate data for PK analysis and dose-response relationship.
- The successful candidate will oversee the development, validation, and implementation of bioanalytical methods to support novel drug discovery and development.
- Ensure accurate analysis of biological samples, grow and lead a scientific team, and collaborate cross-functionally to ensure regulatory compliance and timely delivery of project goals.
- Manage bioanalytical CROs for method optimization, assay transfer, qualification/validation, sample testing, and delivery of results within program timelines.
- Draft, review, and finalize bioanalytical study reports that adhere to regulatory guidelines for IND/CTA filing.
Travel:
- Occasional domestic or international travel as needed.
Qualifications:
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Immunology, Biochemistry, or related discipline preferred, with >7 years of biotechnology /pharmaceutical industry experience and 5 years of people management responsibilities.
- Alternatively, an MS with >8 years or a BS with >10 years of industry experience would also be considered.
- Significant expertise in the design, development, and phase-appropriate qualification/validation of ligand-binding and cell-based assays for nonclinical and clinical studies in compliance with regulatory guidelines (FDA, EMA, and ICH).
- Proficient in bioanalysis processes, tools, and instrumentation for biologic discovery and development.
- Hands-on working knowledge of immunogenicity assessment of biologics.
- Excellent critical thinking, communication, and collaboration skills, with experience working cross-functionally within internal teams and CROs.
Pay Range & Benefits:
- The base salary range for this role is $154,800.00 - $258,000.00. The pay range provided is an estimated base range for this role. Exact compensation may vary based on skills, experience, and education.
- We offer an excellent benefits program, including Medical, Dental, and Vision plans, company-paid holidays, and more!
About Ouro Medicines:
Ouro Medicines is an early-stage biotherapeutic company located in San Francisco. Our purpose is to develop novel therapeutics that redefine the future for people with immune-mediated diseases. We have a growing pipeline of antibody-based therapeutics at different stages of research and development.
To Apply for this Role:
Please send an email with your resume and cover letter to careers@ouromeds.com.