Manager, Clinical & Product Operations

siphox Health; Burlington (MA); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

SiPhox Health is building the leading at-home health testing platform. This early-career role supports the Director of Clinical Operations across compliance, quality, new product launches, and complaints handling, ensuring results are accurate, timely, and auditable.

You will catch errors, coordinate across clinical, product, operations and software, and help write the procedures that sustain scalable launches and regulatory readiness.

Qualifikationen

• Bachelor's degree in health, life science, or chemistry-related field required.
• At least 1 year of professional experience after college in a health or product role.
• Comfortable reading lab results, including units, reference ranges, and what makes a value abnormal.
• Highly organized: you can keep a launch checklist moving across five teams without losing track of a single sign-off.
• Strong documentation habits: you write things down so the next person, or the auditor, doesn't have to guess.
• Comfortable with spreadsheets, ticketing systems, and shared documentation tools.

Aufgaben

• Catch errors before they reach a customer.
• Keep launches on track across clinical, product, operations, and software.
• Manage HIPAA compliance and complaints handling day-to-day.
• Keep company assets organized and build the processes the rest of the team relies on.
• Work alongside the clinical team as we build new panels, kits, and results features.

Ausbildung

Bachelor's degree in health, life science, or chemistry-related field

Tools

Spreadsheets

Ticketing systems

Jobbeschreibung

At-Home health monitoring with silicon photonic chips for data centers

Reports to: Director of Clinical Operations

About SiPhox Health

SiPhox Health is building the leading home testing platform for biomarkers across inflammation, hormones, and metabolic and cardiovascular health. Six in ten Americans live with a chronic disease, and our mission is to make early detection possible from home.

• Mail-in blood testing: Growing more than 50% quarter over quarter, and the most comprehensive and highly rated at-home blood testing available today.
• At-home blood testing device: Planned launch in 2027. Our chip-based module combines biochemistry with integrated photonics, electronics, and microfluidics, protected by more than 50 patents.

SiPhox is an MIT startup backed by Tier I investors including Y Combinator, Khosla Ventures, and Intel Capital.

The Role

This is an early-career role, but it is not a low-stakes one.

Every result we release comes from a customer's own blood sample, processed by a regulated laboratory. It returns to them as a number they will base health decisions on. Our Director of Clinical Operations is accountable for that entire pipeline. You will be their right-hand across four areas: compliance, quality, new product launches, and complaints handling.

In practice, you will:

• catch errors before they reach a customer
• keep launches on track across clinical, product, operations, and software
• manage HIPAA compliance and complaints handling day-to-day
• keep company assets organized and build the processes the rest of the team relies on

You will also work alongside the rest of the clinical team as we build new panels, kits, and results features.

The standard is simple: every result we deliver must be accurate, on time, and backed by processes that hold up to an audit.

We are looking for someone early in their career who is meticulous, organized, and steady when a launch deadline, an audit request, and hundreds of open complaints all compete for attention. Candidates who need a fully mature organization with a documented procedure for every situation will not find that here. You will help write those procedures while the operation runs at full speed.

Areas of Ownership

Compliance

• Support the Director in keeping clinical operations in line with HIPAA and FDA requirements
• Maintain compliance documentation, records, and evidence so we are ready for audits and partner lab inspections at any time
• Track business associate agreements (BAAs), vendor compliance documents, and renewal dates
• Run HIPAA housekeeping: access reviews, training completion, and prompt reporting of potential incidents
• Maintain training records, competency checklists, and credentialing files (license verification, renewals) for employed and contracted clinical staff

Quality

• Review the processes for result monitoring, critical and abnormal value escalation, and pre-release checks; flag gaps and propose improvements to the Director
• Audit the review workflows for biomarker panels, reports, automated insights, and AI-generated summaries, and make sure they are documented, followed, and working as intended
• Draft and update SOPs and work instructions for approval, and keep document control tight so the approved version is always the one in use
• Log deviations and track corrective and preventive actions (CAPAs) to completion
• Track sample rejection and redraw reasons (hemolysis, insufficient volume, transit delay) and share patterns with product and operations
• Review physical and electronic kit instructions for accuracy and keep printed and digital versions in sync

Complaints handling

• Own the complaint log, with intake from customer support, reviews, B2B partners, and labs
• Triage each complaint for clinical and safety significance, and escape potential adverse events or result errors to the Director immediately
• Coordinate investigations with the lab, manufacturing, operations, and software teams, and document root cause and resolution
• Report complaint trends monthly so recurring problems get fixed at the source

New product launches

• Coordinate the clinical workstream for new panels, kit variants, and results features, from requirements through launch
• Maintain launch checklists and track clinical sign-offs, validation documentation, and regulatory review
• Make sure SOPs, training, health content, and kit instructions are updated before anything goes live
• After launch, monitor early results, complaints, and redraw rates and report what needs to change

Building products with the clinical team

• Help the clinical team document requirements for new products: biomarkers, reference ranges, interpretation rules, and insight content
• Build and run test cases (edge cases, borderline values, unusual combinations) for new reports and AI features before release
• Prepare literature summaries to support clinical content and product decisions
• Fact-check health content, route it for clinical approval, and keep the approval record
• Audit a sample of coaching conversations and content against our line between health coaching and medical advice

Qualifications

• Bachelor's degree in a health, life science, or chemistry-related field (e.g., biology, biochemistry, chemistry, biomedical engineering, biotechnology, biomathematics, nursing, clinical laboratory science)
• At least 1 year of professional experience after college in a health or product role
• Comfortable reading lab results, including units, reference ranges, and what makes a value abnormal, or able to learn quickly
• Highly organized: you can keep a launch checklist moving across five teams without losing track of a single sign-off
• Strong documentation habits: you write things down so the next person, or the auditor, doesn't have to guess
• Comfortable with spreadsheets, ticketing systems, and shared documentation tools
• A plus: hands-on experience as a phlebotomist, medical assistant, lab technician, or EMT

Personal Characteristics

• Rigorous attention to detail: you catch the wrong unit, the swapped range, the typo in step 4 of the instructions
• Composure under pressure: to you, a spike in complaints or a slipping launch calls for a procedure, not a panic
• Ownership: you follow an escalation, a complaint, or a launch task until it's closed, not just until it's handed off
• Process-minded: when you see something done three different ways, you fix it once and write it down
• Eager to learn: you want to grow into clinical operations, quality, regulatory, or product work, and you'll get a close view of all four
• Low ego and high standards: willing to do unglamorous work while holding the bar high

Compensation and Benefits

• $80,000 - $110,000
• Stock options, and meaningful equity in a company solving a problem that matters

Wearable and At-Home protein monitoring with silicon photonic chips