Biosample Operations Manager

Who we are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.

Position Description:

Calico is seeking a Biosample Operations Manager (BOM) that will oversees the collection, delivery and assay of biosamples including Biomarkers, PK and PD within clinical studies and will support discovery and biomarker efforts for clinical programs. The BOM will establishes workflows and timelines for analytical needs and ensures biosample process consistency across all clinical studies within their respective projects and manages sample logistics from patient to data. The successful candidate will have experience bridging both science and operations though cross functional partnerships, strategic project planning and facilitating key biomarker execution discussions while contributing to a positive and collaborative team environment.

Key Responsibilities:

• Liaise with translational, biomarker and pharmacokinetic scientists and clinical teams to establish analysis needs with clinical feasibility
• Drive the implementation and execution of the clinical biomarker strategy for clinical studies by establishing productive working relationships with sites, vendors, partners, and other stakeholders to ensure on time and quality deliverables
• Serve as an active member of the Study Management Team to obtain and provide updates on the progress of the trial regarding sample management
• Identify issues, mitigate risks and escalate as appropriate to ensure accuracy in sample collection, delivery, and analysis
• Contribute to central lab setup and management
• Manage relationships with specialty vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet timelines and specifications
• Draft and review laboratory manuals to ensure accuracy and consistency with the study protocol and clinical needs
• Contribute to the preparation of other clinical documents such as clinical protocol, clinical study reports, informed consent forms, sample management plan and site training materials
• As needed, manage relevant sample logistics and facilitate sample shipments and query resolutions among vendors or collaborator to ensure timely delivery

Candidate Requirements:

• BS in life sciences required (MS, PhD or PMP certification highly desired)
• 5+ years of clinical development experience in a biotech/pharma industry
• Detailed oriented mindset with exceptional organization skills and a passion for delivering quality results
• Robust knowledge of drug development including ICH GCP and GLP guidance
• Proven ability to successfully manage multiple competing priorities
• Strong interpersonal skills to build and maintain positive working relationships
• Excellent verbal and written communication skills
• Self-motivated and able to work independently as well as collaboratively
• Ability to “roll up sleeves” in a start-up environment
• A positive can-do attitude
• Have a strong understanding of scientific needs as well as clinical processes to bridge the needs between these functions
• Must be willing to work onsite at least three days per week

Calico requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Calico will consider requests for Reasonable Accommodations.