Clinical Biomarker Scientist

Octant Bio • Emeryville, CA

359d • $145,000 - $170,000

About The Position

Octant is looking for a Biomarker Scientist that will play a crucial role in advancing our small molecule drug pipeline, in large part through supporting our research and clinical development activities across our rare disease pipeline. This position will be responsible for defining and executing biomarker strategies in our clinical trials, and using human clinical translational research to generate and validate novel biomarker approaches. You will direct the development, outsourcing and validation of clinically applicable biomarker assays and design, implement and oversee biomarker testing and data analysis. You will provide input on clinical protocols and associated documents as well as participate in meetings with regulatory authorities. You will also identify, establish and oversee external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers. In particular, you will need to be able to guide the development, validation/qualification of LC-MS assays in support of pharmacokinetic (PK), toxicokinetic (TK), Biomarker Quantification in variety of biological matrices (urine, plasma, skin, kidney in particular ) and develop ex vivo assays for determining biological activity across a variety of tissue samples. You are motivated by Octant's mission and have a team-first mindset. You bring strong technical skills with technological and methodological expertise as it is applied to nonclinical pharmacology and toxicology work, excellent communication, and an ability to thrive in a dynamic and fast-paced environment.

Requirements

• Have a Ph.D. in Pharmacology, Biomedical Sciences, or a related field, with a minimum of 5 years of post-graduate experience in biomarker development, preferably in the biotechnology or pharmaceutical industry; or equivalent experience.
• Have experience running Biomarker development studies at CROs.
• Demonstrate competency in troubleshooting, optimization and implementation of challenging and innovative LC-MS/LC-MS-MS assays.
• Have experience developing ex vivo assays for determining biological activity from various tissue and blood specimens.
• Have extensive experience working with CROs, including contracting, study design, and management.
• Have experience developing small molecule therapeutics with knowledge of general toxicology, pharmacology, and safety.
• Have proven ability in writing and reviewing scientific and regulatory documents, with specific experience in preparing study reports for IND submissions.
• Possess excellent analytical, organizational and communication skills.
• Hold a strong commitment to ethical research practices and adherence to animal welfare standards.
• Enjoy working seamlessly across functions.
• Are detail-oriented and thrive in a fast-paced, collaborative, team-oriented startup environment.

Responsibilities

• Design and implement biomarker testing strategies to support our clinical development plans.
• Devise and strategize which assays to build internally versus outsource and support/validate outsourced efforts.
• Oversee and manage relationships with CROs to ensure high-quality, timely, and cost-effective study execution and documentation.
• Conduct detailed review and analysis of study data, ensuring rigorous scientific validity and compliance with regulatory standards.
• Write, review and finalize study reports, contributing to the preparation of IND applications and other regulatory submissions.
• Stay abreast of the latest scientific advances and regulatory guidelines in relevant disease areas and pharmacology.
• Present findings to internal teams and at scientific conferences, as well as contribute to scientific publications.

Benefits

• Health benefits (medical, dental, vision)
• Equity
• 401(k) matching

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 51-100 employees