Senior Manager, Clinical Biomarker Operations
San Diego, CA
Clinical – Clinical Operations /
Full-Time /
On-site
Janux Therapeutics is seeking a seasoned Clinical Biomarker Operations professional to lead the operational execution of biospecimen logistics and drive the implementation of biomarker strategies across clinical programs.
This role offers the chance to shape the success of biomarker initiatives by managing the full spectrum of clinical sample logistics and fostering cross-functional collaboration. The ideal candidate brings deep expertise in navigating complex operational workflows and a commitment to delivering high-quality, timely biomarker data that supports transformative clinical research.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Lead or support the development and execution of biomarker sample operations across clinical trials, ensuring compliance with ICH/GCP/GLP and regulatory standards.
- Provide strong oversight across the full biospecimen lifecycle—from site collection and processing to storage, shipment, and data delivery.
- Draft and maintain essential clinical documents including lab manuals, sample management plans, ICFs, and site training materials.
- Coordinate with clinical sites, central labs, and specialty vendors to ensure proper sample handling and timely data reporting.
- Maintain specimen chain of custody.
- Oversee or contribute to the implementation and maintenance of a LIMS or sample tracking system, including SOP development and user training.
- Participate in clinical study startup activities, including lab kit design, logistics planning, and vendor onboarding.
- Support Central lab selection, contract review, operational set-up and maintain ongoing oversight.
- Develop site training for biospecimen collection/ processing/ logistics.
- Monitor biomarker sample metrics, resolve operational issues, and ensure alignment with study timelines and quality expectations.
- Identifying, developing, and implementing risk mitigation strategies for sample management.
- Lab vendor oversight and issue escalation responsibilities.
- Collaborate with internal stakeholders (e.g., Clinical Operations, Translational Science, Data Management) to ensure biomarker goals are met.
- Identify and implement process improvements to enhance operational efficiency and data integrity.
- Manage biomarker operations team and ensure standard processes are implemented across programs.
- Set-up operational workflows and processes for in-house accession and storage of clinical samples at Janux labs.
- Other activities as required.
REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES
- Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
- Minimum of 6 years of relevant experience in clinical biomarker operations or translational research.
- Direct experience managing tumor biopsy and blood-based biomarkers in oncology and autoimmune clinical trials.
- Laboratory and data management experience is a plus
- Strong background in vendor oversight, sample logistics, and biomarker data delivery.
- Proficiency with LIMS and sample tracking systems.
- Working knowledge of GCP, GLP, and regulatory requirements for human biospecimens.
- Highly organized, detail-oriented, and proactive.
- Strong communicator with the ability to work cross-functionally and influence without authority.
- Comfortable in a fast-paced, hands-on environment with evolving priorities.
$150,000 - $175,000 a year
In addition to a competitive base salary ranging from $150,000 to $175,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.
Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.
Job Type: Full-time
Benefits:
· 401K
· Medical insurance
· Dental insurance
· Vision insurance
· Supplemental disability insurance plans
· Flexible schedule
· Life insurance
· Flexible vacation
· Sick time
· Incentive stock option plan
· Relocation assistance
Schedule:
· Monday to Friday
Work authorization:
· United States (Required)
Additional Compensation:
· Annual targeted bonus %
Work Location:
· On site (San Diego, CA)
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies
The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
