Senior Specialist, Biomarker Operations

Denali Therapeutics

Denali Therapeutics

San Francisco, CA, USA
Posted on Thursday, July 27, 2023

The Opportunity:

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

Denali Therapeutics is seeking to recruit a Biomarker Operations Sr. Specialist in support of the company’s Development Operations efforts. This individual represents Development Operations for assigned studies/programs and activities regarding biologic sample management for Clinical studies, as well as Biomarker collaborations. Responsible for developing sample collection strategy, ensuring accurate laboratory specifications, and providing visibility and control of biological samples and tissues globally. Additional tasks include participating in process improvement projects and maintaining the biorepository database (e.g. LIMS).


  • Manage sample lifecycle processes for clinical and biomarker studies.
  • Collaborate with the study and/or project teams to develop biological sample management plans for PK, PD, Genomic, and Biomarker samples.
  • Collaborate with clinical study sites, Contract Research Organizations (CROs), and Central Laboratories.
  • Review and provide feedback on Clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.
  • Interface with laboratory personnel, sample processing vendors or sites, and other vendors as needed to ensure proper collection and shipment of samples, respond to issues/queries as needed, and to ensure study objectives are met.
  • Coordinate incoming and outgoing clinical study supply shipments.
  • Assist in the development and maintenance of a central biorepository database (e.g. Laboratory Information Management System).
  • Ensure sample integrity and maintain GCP and GDPR compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions.
  • Participates and/or leads process improvement projects (SOPs, Work Instructions, training materials).


  • Bachelor’s degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field is required, with a 3-5 years in Translational Medicine or Clinical Development, or related field and/or training
  • Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling
  • Technical knowledge to maintain electronic files and experience with database entry (e.g. LIMS, excel)
  • Entrepreneurial spirit with “can do” attitude, commitment to teamwork, and initiative
  • Seeks change & values innovation
  • Advanced planning and organization skills
  • Excellent analytical and assessment skills
  • Ability to work effectively in a cross-functional team matrix environment

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $107,000 to $130,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at

*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Applicant Privacy Policy