Senior Manager, Biomarker Operations

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.   

The Senior Manager, Biomarker Operations will lead the implementation and execution of clinical sample collection, testing, and data delivery activities for both early and later-phase clinical programs in the autoimmune therapeutic area. The ideal candidate will have experience bridging both science and clinical operations through cross-functional partnerships, strategic project planning, and facilitating key biomarker and genomic execution discussions.

Essential Responsibilities

• Implement and execute the clinical biomarker strategy for early and late-stage autoimmune disease programs.

• Create and manage biomarker plans, trackers, timelines, budgets, risk assessments, and quality metrics during study startup, conduct, and closeout.

• Collaborate with procurement and scientific leads to execute contracts and statements of work to meet program deliverables.

• Contribute to central lab setup and management throughout a study.

• Oversee PK, PD, Biomarker, Safety labs, and drug metabolism (e.g., CYP2D6) testing.

• Manage relationships with specialty testing vendors to ensure biomarker/NGS samples are processed, tested, and data is reported to meet development timelines and specifications.

• Work closely with data management to establish data collection and transfer specifications with testing vendors and central/specialty labs.

• Contribute to the preparation of clinical documents such as clinical protocols, clinical study reports, lab manuals, informed consent forms, biospecimen management plans, early development plans, and clinical site training materials for SIVs and IMs.

• Collaborate with scientific stakeholders to identify innovative biosample collection and processing techniques and ensure methods are implemented appropriately across clinical sites to the highest standards.

• Develop presentations and present sample tracking/testing metrics at regular team meetings.

• Evaluate and implement new assays and relevant technologies as required by the program.

• Manage relationships with internal and external partners to ensure on-time and quality deliverables.

• Participate in cross-functional study team meetings across clinical, biomarker subteams, and genetics.

• Contribute to Clinical Operations/Organizational initiatives to build and optimize business procedures, tools, and guidance.

• Collaborate with Quality Assurance to establish and perform audits, CAPAs, and ensure selected specialty labs/CROs follow quality metrics and KPIs to ensure data integrity.

• Review TMF filing documents originating from specialty labs/CROs in accordance with regulatory requirements.

People Manager (if applicable):

• Develop, train, and oversee junior biomarker/biosamples specialists.

• Provide assay development, validation, and troubleshooting in collaboration with Precision Medicine/Biomarker Scientist.

• Ensure direct reports comply with regulatory requirements, SOPs, Work Instructions, and OJTs.

• Act as an escalation point for biomarker/biosample queries for the SET, CDT, and PC as needed.

Professional Experience / Qualifications / Education

• Bachelor's degree in a Life Science field (minimum) with 5 years of relevant work experience in clinical trials; MS/PhD with 3 years of relevant work experience.

• For people managers: aleast 2 years of people management experience with direct reports.

• Strong knowledge and understanding of clinical drug development, strategic planning of clinical research, ICF, ICH GCP, and GLP.

• Knowledge of drug development and/or biomarker/diagnostic development.

• Ability to work effectively and collaboratively on global cross-functional teams.

• Knowledge of clinical biomarker sample and clinical pharmacokinetic sample preparation.

• Strong leadership, troubleshooting, and influencing skills for quality and delivery.

• Outstanding communication skills (written, verbal, and oral presentations). Comfortable communicating with PIs, site, and upper management.

• Effective listening skills and ability to invite responses and discussions with internal partners and external service providers.

• Proficient in risk management to prevent and overcome complex issues during clinical trial execution.

• Adaptability to modify plans based on changing priorities.

• Comfortable in a fast-paced, results-driven, highly accountable environment with a large potential impact.

• Project management experience preferred.

Alumis Values

• Elevate

• Challenge

• Nurture

   

This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.   

  

The salary range for this position is $178,000 USD to $190,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.  

Alumis Inc. is an equal opportunity employer.