Head of Clinical Services

Science; Alameda (CA); Hybrid; USD 175,000 - 250,000; Full time

Benefits offered by this job

Medical, dental, vision

Flexible vacation and holidays

Meals for non-remote employees

Parental, jury duty, bereavement leave

Dependent Care FSA

401(k)

Job summary

Science is seeking a Head of Clinical Services to lead quality assurance, regulatory affairs, clinical operations, sterilization, and clinical software. This senior role reports to the CEO and builds scalable functions for trials, post-market surveillance, and services across the Science ecosystem.

The candidate will drive global regulatory strategy, ISO 14155 compliance, and QMS across the US, EU, UK, and Australia, while defining offerings and partnerships.

Qualifications

• 15+ years leading medical device quality, regulatory, or clinical affairs.
• At least 5 years in senior leadership roles managing leaders across QARA/clinical operations.
• Executive accountability for Class III or implantable device programs from regulatory approval through clinical completion.
• Deep knowledge of ISO 13485, 21 CFR Part 820, EU MDR, ISO 14155, ISO 11135.
• Experience scaling regulated operations and building tools (LLM-based) to automate quality, regulatory, or clinical work.
• Ability to ship with engineers and apply risk-based approaches quickly while protecting safety and data integrity.

Responsibilities

• Oversee QARA, clinical operations, sterilization, and clinical software; set priorities, budgets, and service levels.
• Define products, scope, pricing, SLAs, and contract terms; collaborate with commercial and legal teams; own financial performance.
• Executive accountable for Quality Management System and global regulatory strategy; act as MR for audits/inspections in US, EU, UK, AU.
• Ensure success of clinical trials from protocol design to close-out in compliance with ISO 14155 and GCP.
• Oversee strategy and development of the clinical trial and commercial software platform.
• Oversee sterilization validation and processing for implantable devices and research hardware (ISO 11135).
• Scale operations to support growing portfolio and external customers; leverage software/LLM workflows to improve speed and reliability.
• Represent clinical, quality, and regulatory requirements at executive level; partner across functions to embed requirements in product roadmaps.

Job description

Science is a vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost them. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

As Head of Clinical Services, you’ll lead Science’s quality assurance and regulatory affairs (QARA), clinical operations, sterilization, and clinical software functions. Your first priority is to ensure each function meets the requirements of Science’s internal programs, from preclinical studies and clinical trials through manufacturing and post-market surveillance. Ultimately, you’ll build these functions into a set of products that external partners, including companies building on the Science Ecosystem or Foundry, can use to run trials, maintain quality systems, and sterilize devices. The right candidate has extensive experience building and running QARA teams and clinical trials for implantable or high-risk devices, and strong instincts for using software to let a small team do work that would usually take a much larger one. This is a senior leadership role that reports to the CEO.

Role Responsibilities:

• Oversee Science’s QARA, clinical operations, sterilization, and clinical software teams. Set priorities, budgets, and hold each function to defined internal service levels for speed, quality, and cost.
• Build and run the Clinical Services business. Define the product offerings, scope, pricing, service levels, and contract terms; work with commercial and legal teams to win and support external partners; and own the function’s financial performance.
• Serve as the executive accountable for Science’s Quality Management System and global regulatory strategy. Act as management representative for notified body audits and regulatory inspections. Make final calls on high-stakes regulatory and clinical decisions across the United States, European Union, United Kingdom, and Australia.
• Ensure to success of Science’s clinical trials from start to finish, including protocol design, site selection and activation, monitoring, data management, safety reporting, and close-out, in compliance with ISO 14155 and GCP.
• Oversee the strategy and ongoing development of Science’s clinical trial and commercial software platform.
• Oversee sterilization validation and routine processing for implantable devices and research hardware, including method selection, cycle development, and compliance with ISO 11135.
• Scale QARA, clinical, sterilization, and clinical software operations to support a growing portfolio and external customers without a proportional increase in headcount. Use software and LLM-assisted workflows wherever they make work faster and more reliable.
• Represent clinical, quality, and regulatory requirements at the executive level. Partner with medical, engineering, manufacturing, legal, and commercial leadership to ensure these requirements are built into product roadmaps from the start.

Key Qualifications:

• 15+ years leading medical device quality, regulatory, or clinical affairs, including at least 5 years in senior leadership roles managing leaders across QARA and/or clinical operations.
• A track record of executive accountability for Class III or implantable device programs, from initial regulatory approval through clinical completion.
• Experience building or running a services business in a regulated industry, such as a CRO, contract sterilizer, or regulatory consultancy, or running an internal function as a service with defined customers and service levels.
• Deep working knowledge of relevant laws, regulations, and standards, including ISO 13485, 21 CFR Part 820 (QMSR), EU MDR, ISO 14155, and ISO 11135.
• Experience scaling regulated operations through process design, partnerships, and software, including specifying or building tools (LLM-based tools among them) that automate quality, regulatory, or clinical work, and comfort working directly with engineers to ship them.
• Sound judgment in applying a risk-based approach that moves quickly without compromising patient safety or data integrity.

Preferred Qualifications:

• Experience with active implantable devices, neurotechnology, or brain-computer interfaces.
• Experience with HDE, Breakthrough Device, or early feasibility study pathways.
• Experience leading organizations across multiple geographies, especially the United States and Europe.
• Professional French is a plus.

Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. The base salary range for this full-time position is $175,000-$250,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.

At Science, our benefits are in place to support the whole you:

• Competitive salary and equity
• Medical, dental, vision, and life insurance
• Flexible vacation and company-paid holidays
• Healthy meals and snacks provided for non-remote employees
• Paid parental, jury duty, bereavement, family care, and medical leave
• Dependent Care Flexible Spending Account, subsidized by Science
• Flexible Spending Account
• 401(k)

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, and local laws.