Associate Director, Biomarker Bioanalysis
Job Posting for Associate Director, Biomarker Bioanalysis at Crinetics Pharmaceuticals
POSITION SUMMARY:
Crinetics Pharmaceuticals is seeking an experienced scientist to join its growing and dynamic development team. This individual will be responsible for the management of outsourced biomarker activities including platform/assay selection, development, validation, and utilization in nonclinical and clinical development. The work will support projects at various stages of development thereby allowing the selected candidate to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community. (Position will be filled at level commensurate with experience)
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs for the successful development and/or implementation of biomarker assays in various platforms (LC/MS, ligand-binding assay (LBA), hybrid LBA-LCMS assays) and in different settings (BA, IVD, LDT/RUO).
- Development appropriate biomarker analysis strategy for Crinetics’ drug candidates in support of clinical and non-clinical studies based on study objectives.
- Apply fit-for-purpose biomarker validation approach complied with FDA and global regulatory guidance under bioanalytical setting and follow CMS/CLIA and ISO guidance for the biomarker assays in clinical testing.
- Review and finalize method validations protocols, stability studies, and bioanalytical reports. Participate in the periodic audit of bioanalytical CROs and ensure the accreditation compliance of the CLIA clinical testing labs.
- Work with cross-functional colleagues in various programs to determine assay needs and manage assay selection, sample analysis, and reporting of results in a timeframe consistent with study and program goals.
- Manage and negotiate scopes of work, budget, and payment schedules for outsourced bioanalysis/biomarker assay activities.
- Review invoices against vendor contracts to ensure accuracy and service completion.
- Contribute to bioanalytical report and relevant bioanalytical sections of CSRs, and other regulatory and submission documents
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- BS/MS/PhD in a relevant scientific field with significant industry experience in a bioanalytical/biomarker function (10 years of industry experience, with 7 years of management experience, Ph.D. preferred) in LCMS and/or LBA method development, sample analysis, and managing outsourced biomarker assay activities. Equivalent education and experience will be considered.
- Strong scientific and operational background in small and large molecule bioanalytical and biomarker method development, validation, data interpretation, reporting of sample analysis results.
- Thorough understanding of bioanalytical and biomarker methodologies, GLP/GCLP requirements, ICH guidelines, and FDA guidance for bioanalytical assay validation and sample analysis.
- Experience in CLIA clinical testing laboratory and central lab is a plus.
- Proven ability to oversee validation work and sample analysis at CRO
- Highly knowledgeable on domestic and international service providers
- Familiarity with all stages of nonclinical and clinical drug development, including prior experience in fit-for-purpose concept in assay development strategy
- Strong written, presentation and verbal communication skills
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software recommended: Watson LIMS.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: not applicable.
Laboratory Activities, if applicable: not applicable.
TRAVEL:
Travel may be required up to 5-10% of your time.
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, a 401k, paid time off, and the company provides a dog-friendly work environment.
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Salary.com Estimation for Associate Director, Biomarker Bioanalysis in San Diego, CA
$95,917 to $127,447
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Job openings at Crinetics Pharmaceuticals
Crinetics Pharmaceuticals
Remote in San Diego, CA
Full Time
Crinetics Pharmaceuticals
San Diego, CA
Full Time
Crinetics Pharmaceuticals
San Diego, CA
Full Time
Crinetics Pharmaceuticals
San Diego, CA
Full Time
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