Senior Clinical Affairs Specialist

Senior Clinical Affairs Specialist Confidential Houston, TX 77056 $110,000

• $125,000 a year
• Full-time $110,000
• $125,000 a year
• Full-time About The Company is an innovative medical device organization focused on advancing neurostimulation technologies.

We are dedicated to pioneering new standards of care for mental health. With our lead medical device advancing into pivotal clinical development, we are seeking an experienced Senior Clinical Affairs Specialist to drive the day-to-day execution of clinical studies and support the generation of clinical evidence necessary for regulatory and commercial objectives. The Role The Senior Clinical Affairs Specialist will be the operational owner of our pivotal and post-market clinical programs. This role Reports to the CEO and works closely with the executive team daily. This position is hands-on with study execution, CRO oversight, site management, and clinical data quality, and partners closely with external consultants to ensure clinical results are translated into approvable regulatory packages. Senior Clinical Affairs Specialist candidates should bring deep hands-on trial execution expertise.

Key Responsibilities Clinical Study Execution:

Drive execution of the program and future indication studies, including protocol authorship support, endpoint operationalization, and publication support

Pivotal Trial Operations:

Own hands-on operational delivery of pivotal studies, including site activation, investigator engagement, IRB/EC submissions, monitoring oversight, and data quality

CRO & Site Management:

Serve as the day-to-day point of contact for CRO partners, investigators, and clinical sites, ensuring trials are executed on time, within budget, and in full GCP compliance

Regulatory Submission Support:

Author and contribute clinical sections of FDA De Novo, follow-on 510(k), and CE Mark (MDR) submissions; ensure all clinical data is "submission-ready"

Health Authority Support:

Prepare clinical content for FDA Pre-Submissions, EMA scientific advice, and Notified Body interactions; participate in meetings as a clinical subject matter expert

Post-Market Clinical Follow-Up:

Support PMCF study execution and real-world evidence collection in coordination with quality and regulatory functions

Required Qualifications Education:

Bachelor's degree in a clinical, scientific, or engineering discipline required; Advanced degree preferred

Experience:

5-10 years of clinical research / clinical affairs experience in the medical device industry, with progressive responsibility running studies end-to-end

Clinical Domain Expertise:

Direct experience executing pivotal IDE / IDE-exempt studies for Class II/III medical devices, ideally in neurostimulation, neuromodulation, neurology, or psychiatry indications

Trial Execution:

Hands-on experience overseeing CROs and clinical sites for multi-site trials, including budget tracking, timeline management, and data integrity

Submissions Experience:

Contribution to clinical sections of US (510(k) / De Novo / PMA) and/or European (MDR) submissions through to clearance or approval

Technical Knowledge:

Working knowledge of GCP and Clinical Regulation (ISO 14155, ICH E6(R3) GCP, and 21 CFRs 50, 56, and 812); familiarity with QMSR and EU MDR is a plus (21 CFR 820 and

EN ISO 13485

) Proficiency in Microsoft Office and Google Workspace Preferred Skills Deep hands-on monitoring, study start-up, and CRA / clinical operations experience Background in neuroimaging (EEG, qEEG, fMRI) and digital biomarkers as clinical evidence Experience with decentralized / "virtual clinic" trial models and digital health integration; strong written communication for presenting clinical data to internal stakeholders, investigators and KOLs Compensation & Benefits Base Salary (USD, annual)

Senior Clinical Affairs Specialist:

$110,000

• $125,000. Houston, TX based Annual Cash Bonus Target 10% of annual base salary, tied to clinical trial milestones (enrollment, database lock, submission readiness) and overall company performance Equity Initial stock option grant valued at approximately $15,000
• 50,000 (vesting over 3 years) plus eligibility for annual refresh grants Benefits Medical, dental, and vision insurance; paid time off; employee stock incentive plan (if applicable); and professional development support.

Pay:

$110,000.00

• $125,000.

00 per year

Benefits:

Dental insurance Health insurance Paid time off Relocation assistance Vision insurance

Work Location:

In person