Clinical Biomarker Scientist

COMPANY

Octant is a well-backed team of experienced scientists and entrepreneurs at the frontiers of biology, chemistry, and computation. We are a small molecule therapeutics company combining high-throughput synthetic biology, generative chemistry, and AI/ML to repeatedly develop precision medicines for genetically defined diseases.

JOB DESCRIPTION

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.

AS A PART OF OCTANT'S DISCOVERY BIOLOGY & EARLY CLINICAL DEVELOPMENT TEAM, YOU WILL:

• 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.

THIS JOB MIGHT BE GREAT FOR YOU IF YOU:

• 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.

The expected annual salary for this role is in the range of $145,000 to $170,000, depending on experience level. We offer health benefits (medical, dental, vision), equity, and 401(k) matching.

Octant is located in Emeryville, California and we work onsite.

Octant is an equal opportunity company that values applicants of all backgrounds. We’re committed to fostering an inclusive and supportive work environment. We value less traditional backgrounds, and may consider an equivalent combination of knowledge, skills, education, and experience to meet minimum qualifications. We know that confidence-gap and imposter syndrome can get in the way of meeting spectacular candidates, so please don’t hesitate to apply — we’d love to hear from you.