VP, Clinical Operations

ChronicleBio; Menlo Park (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

ChronicleBio in Menlo Park, CA seeks a VP of Clinical Operations to build and run the operational backbone of clinical programs, from adaptive trial designs to IND-enabled studies. This hands-on leader will oversee translational and interventional trials, biobank activities, and vendor relationships.

You will recruit and manage a clinical operations team, design SOPs, and partner with finance to manage the program budget, driving biomarker-driven patient stratification and data quality across

Qualifications

• 10+ years in clinical operations within biotech/pharma.
• Experience building operations infra (SOPs, vendors, site networks).
• Fluency with adaptive trial design and operational implications.

Responsibilities

• Design and stand up operational infrastructure for interventional trials (adaptive to IND).
• Build playbooks, SOPs, and vendor/site relationships for trials.
• Translate regulatory/strategy into executable trial ops plans.
• Manage clinical operations calendar and resources across programs.
• Ensure endotype-based patient stratification and biomarker needs are reflected.
• Own vendor selection and management for labs, data platforms, etc.
• Build and manage the clinical operations budget with finance.
• Recruit and manage a clinical operations team as programs scale.
• Oversee biobank studies, enrollment, sample logistics, data capture quality.
• Manage network of Participating Sites and Site PIs.

Skills

Clinical Operations

IND trials

Observational/RWD

IRB/Consent

Multi-site mgmt

Adaptive design

Job description

ChronicleBio is a clinical-stage precision techbio company developing biomarker-guided treatments for ME/CFS, Long COVID, POTS, and related neuroimmune conditions. Our platform combines a large-scale biobank with an endotype-driven diagnostic and therapeutic strategy, allowing us to match existing and novel therapeutics to the specific drivers of each patient's disease. We are a mission-driven team aiming to lead discovery in the largest unmet needs in healthcare.

About ChronicleBio

ChronicleBio is a clinical-stage precision techbio company developing biomarker-guided treatments for ME/CFS, Long COVID, POTS, and related neuroimmune conditions. Our platform combines a large-scale biobank with an endotype-driven diagnostic and therapeutic strategy, allowing us to match existing and novel therapeutics to the specific drivers of each patient's disease. We are a mission-driven team aiming to lead discovery in the largest unmet needs in healthcare.

The Role

ChronicleBio is looking for a VP of Clinical Operations to build and run the operational backbone of our clinical programs with primary focus on our upcoming slate of translational and interventional trials, from adaptive trial designs through to formal IND-enabled studies, and secondary oversight of our biobank and observational pilot operations. This is a hands-on operational leadership role, not a strategic-advisory seat.

What You'll Own

Translational & Interventional Trial Program Operations

• Design and stand up the operational infrastructure needed to run ChronicleBio's upcoming slate of interventional trials, spanning adaptive trial designs through to trials conducted under formal IND.
• Build the playbooks, SOPs, and vendor/site relationships (CROs, central labs, phlebotomy/logistics vendors, EDC/e-consent platforms) required to run interventional programs reliably and at scale.
• Serve as the operational owner translating regulatory and commercial strategy into an executable trial operations plan, ensuring study design decisions made upstream are deployable in the field.
• Manage the clinical operations calendar and resourcing across concurrent translational and interventional programs to ensure nothing slips due to operational bottlenecks.
• Partner with key stakeholders to ensure operational plans reflect each program's endotype-based patient stratification and biomarker requirements.
• Own vendor selection and management for clinical operations functions (labs, kit fulfillment, phlebotomy, data collection platforms).
• Build and manage the clinical operations budget in partnership with finance.
• Recruit and manage a clinical operations team as programs scale.

Biobank & Observational Operations

• End-to-end operational oversight of ChronicleBio's biobank studies (currently structured as Chronicle I and Chronicle II under Advarra IRB), including participant enrollment, sample collection logistics, site coordination, and data capture quality.
• Operational management of the network of Participating Sites and Site PIs, ensuring agreements translate into smooth, consistent execution on the ground.
• Oversight of observational pilot studies conducted in partnership with external clinician-investigators, ensuring protocol adherence, data quality, and timely reporting.

What You Bring

• 10+ years in clinical operations within biotech/pharma, with direct experience running both observational/real-world data studies and IND-enabled interventional trials.
• Demonstrated ability to build clinical operations infrastructure from a relatively early stage; you've stood up SOPs, vendor relationships, and site networks, not just managed an existing machine.
• Working fluency in adaptive trial design and the operational implications of adaptive protocols.
• Strong working knowledge of IRB processes, informed consent (including e-consent), and regulatory operational requirements (FDA IND-enabling studies; familiarity with CDRH/812 considerations a plus given our diagnostic-adjacent work).
• Experience managing multi-site networks, including remote/decentralized and kit-based sample collection models.
• Comfort operating in a small, fast-moving company where you will personally build processes rather than inherit them.
• Bonus: experience in rare disease, autoimmune, neuroimmune, or complex chronic illness populations; experience working alongside a biomarker- or diagnostic-driven patient stratification strategy.

Location: Menlo Park, CA

Type: Full-Time