Head of Clinical Services
Alameda, CA$175k - $250kfull-timePosted 2w ago
About the role
Senior leadership role overseeing the QARA, clinical operations, sterilization, and clinical software functions to support preclinical studies, clinical trials, manufacturing, and post-market surveillance; build these functions into products for external partners and ensure compliance with international standards.
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; 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 the 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.
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.
Skills
Required:Quality Management System (QMS)Regulatory strategy and inspections
Benefits
- 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)
Last updated Oct 23, 2026. Interested? Apply on the company site.
About Science Corporation
Transcend the limits of biology
Science Corporation is a clinical-stage medical technology company.
medical technologybrain-computer interfaceneural interfacesvision restorationneurotechnology
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