Position Summary:

The Associate Director of Biomarker Bioanalysis will be responsible for the management of outsourced bioanalysis (Pharmacokinetics, PK) and 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. 

Essential Job 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 bioanalysis (PK) and biomarker assays using either LC/MS, hybrid LBA-LC/MS assays or ligand-binding assay (LBA), in different settings (BA, IVD, LDT/RUO).
• Develop 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.

• Lead preparation of bioanalytical section in regulatory submission, e.g. author and/or review bioanalytical content, methods, and tabulated summaries for applicable IB, IND, and NDA.
• Lead bioanalytical function on written responses to health authority bioanalytical queries.
• Other duties as assigned.

Education and Experience:

• Bachelor’s degree in a relevant scientific field with 10+ years of industry experience in a bioanalytical/biomarker function in LCMS and ligand-binding assay (LBA) method development, sample analysis, and managing outsourced biomarker assay activities. Equivalent education and experience will be considered.
• 7+ years of experience in a supervisory role is required.
• 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.
• Excellent track record of scientific publications is a plus.
• Authoring experience in bioanalytical sections in regulatory submissions if a plus.
• Experience in oversight of bioanalytical CROs in China is a plus.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5-10% of your time.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.