Senior Manager, Biomarker Operations

Foresite Labs

Foresite Labs

Operations
South San Francisco, CA, USA
Posted on Thursday, July 11, 2024

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.

This individual will be accountable for implementation and execution of clinical sample collection, testing, and data delivery activities for both early and later phase clinical programs in the auto-immune therapeutic area. The successful 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.

Key Responsibilities

  • Drives the implementation and execution of the clinical biomarker strategy for clinical programs in early and late-stage auto-immune diseases.
  • Creates and manages biomarker plans and trackers, timelines, budget, risk assessments, and quality metrics during study startup, conduct and closeout.
  • Work effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverables.
  • Contributes to central lab setup and management throughout a study
  • Oversees PK, PD, Biomarker, Safety labs and drug metabolism (e.g. CYP2D6) testing
  • Manages relationships with specialty testing vendors to ensure biomarker/NGS samples are, processed, tested and data is reported to meet development timelines and specifications.
  • Works closely with data management to establish data collection and transfer specifications with testing vendors and central/specialty labs
  • Contributes to preparing clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, biospecimen management plans, early development plans, and clinical site training materials for SIVs and IMs.
  • Works with scientific stakeholders to identify innovative biosample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards.
  • Develop presentations and present sample tracking/testing metrics at regular team meetings
  • May work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program.
  • Manages relationships with internal and external partners to ensure on-time and quality deliverables
  • Participates in cross-functions study team meetings across clinical, biomarker subteams, and genetics.
  • Contributes to Clinical Operations/Organizational initiatives to build and optimize business procedures, tools, and guidance.
  • Collaborate with Quality Assurance to establish and perform audits, and CAPAs and ensure selected specialty labs/CROs follow quality metrics and KPIs to ensure data integrity
  • Responsible for reviewing TMF filing documents that originate from specialty labs/CROs in accordance with regulatory requirement.

People Manager (if applicable)

  • Develops, trains and oversees junior biomarker/biosamples specialists.
  • Provide assay development, validation, and troubleshooting in collaboration with Precision Medicine/Biomarker Scientist
  • Ensures direct reports are in compliance with regulatory requirements, SOPs, Work Instructions, and OJTs
  • Acts as an escalation point for biomarker/biosample queries for the SET, CDT, PC as needed.

Qualifications

  • Life Science degree (Bachelor Minimum) in scientific, medical, or healthcare area required with 5 years of relevant work experience in clinical trials. MS/PhD with 3 years of relevant work experience.
  • People manager (at least 2 years), direct reports
  • Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required
  • Project management experience is preferred
  • Knowledge of drug development and/or biomarker/diagnostic development a must
  • Ability to effectively and collaboratively work on global cross-functional teams
  • Must have knowledge of clinical biomarker sample and clinical pharmacokinetic sample preparation
  • Ability to lead, troubleshoot, and influence for quality and delivery
  • Outstanding ability to communicate openly and clearly (written, verbal and oral presentations in front of PI, sites, and upper management)
  • Ability to listen effectively and invite responses and discussion 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 as required based on changes in priority.
  • Comfortable in a fast paced, results-driven, highly accountable environment with large potential impact.

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.