Associate Director, Biomarker Analysis

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $158k - $197k / year

⏰ Full Time

🟠 Senior

👔 Director

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

📋 Description

• Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs • Develop appropriate biomarker analysis strategy • Apply fit-for-purpose biomarker validation approach • Review and finalize method validations protocols, stability studies, and bioanalytical reports • Participate in the periodic audit of bioanalytical CROs • Work with cross-functional colleagues in various programs • Manage and negotiate scopes of work, budget, and payment schedules • Review invoices against vendor contracts • Contribute to bioanalytical reports and regulatory documents • Lead preparation of bioanalytical sections in regulatory submissions • Lead bioanalytical function on written responses to health authority bioanalytical queries

🎯 Requirements

• Bachelor’s degree in a relevant scientific field • 10+ years of industry experience in a bioanalytical/biomarker function in LCMS and ligand-binding assay (LBA) method development • 7+ years of experience in a supervisory role • Strong scientific and operational background in small and large molecule bioanalytical and biomarker method development, validation, data interpretation, and 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 • Strong written, presentation and verbal communication skills • Excellent track record of scientific publications is a plus • Authoring experience in bioanalytical sections in regulatory submissions is a plus • Experience in oversight of bioanalytical CROs in China is a plus

🏖️ Benefits

• Health insurance plans for employees and their families (medical, dental, vision and basic life insurance) • 20 days of PTO • 10 paid holidays • Winter company shutdown • Discretionary annual target bonus • Stock options • 401k match