Description
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology.
We are seeking an experienced and strategic Director, Clinical Affairs to lead the planning, execution, and oversight of clinical studies supporting the development, regulatory approval, reimbursement, and commercialization of Noctrix Health’s medical devices. This leader will be accountable for the successful delivery of clinical programs, ensuring studies are executed efficiently, compliantly, on schedule, and within budget while generating high-quality clinical evidence that supports regulatory and business objectives.
The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners. This individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation.
This position reports to the Senior Vice President, Clinical & Regulatory Affairs.
This is a full-time, hybrid position that is located at our Pleasanton headquarters.
Responsibilities:
- Lead the planning, execution, and oversight of medical device clinical studies from study start-up through close-out
- Contribute to clinical development strategies supporting product development, regulatory submissions, reimbursement initiatives, commercialization, and post-market evidence generation
- Provide effective sponsor oversight of clinical trials, including monitoring activities, site performance, protocol compliance, enrollment, and clinical data quality
- Ensure clinical studies are conducted in accordance with applicable FDA requirements, Good Clinical Practice (GCP), ISO 14155, approved protocols, and company procedures
- Develop and manage study timelines, budgets, resource plans, enrollment forecasts, and key milestones
- Proactively identify clinical program risks, develop mitigation strategies, and resolve operational challenges that could impact study timelines, quality, or budget
- Lead clinical site identification, selection, initiation, engagement, performance management, and close-out activities
- Build and maintain productive relationships with investigators, study coordinators, research institutions, and other clinical partners
- Select, manage, and oversee CROs, clinical vendors, consultants, and service providers to ensure quality, timeline, and budget expectations are achieved
- Support the development and review of clinical study protocols, informed consent forms, case report forms, clinical reports, and other study documentation
- Partner with Regulatory Affairs to support regulatory submissions requiring clinical evidence and ensure clinical programs are aligned with regulatory strategy
- Ensure the integrity, completeness, quality, and traceability of clinical data and study documentation
- Support adverse event review, safety monitoring, clinical risk management, audits, regulatory inspections, and applicable Quality System activities
- Collaborate with Product Development, Quality, Regulatory Affairs, and Clinical Research to incorporate clinical insights into product development, risk management, labeling, and post-market activities
- Support the generation of clinical evidence for reimbursement, payer engagement, market access, and commercialization initiatives
- Establish and monitor clinical program KPIs, study performance metrics, and operational dashboards
- Provide executive leadership with regular updates regarding study progress, enrollment, budgets, risks, clinical evidence generation, and key program milestones
- Lead, mentor, and develop Clinical Affairs personnel while establishing clear performance expectations and promoting operational excellence
- Identify and implement opportunities to improve clinical processes, systems, vendor management, and study execution as the organization scales
Requirements:
- Bachelor’s degree in Nursing, Life Sciences, Biomedical Engineering, or a related scientific or technical discipline
- Minimum of 8 years of clinical affairs or clinical research experience within the medical device industry
- Demonstrated leadership experience managing Clinical Affairs personnel, CROs, clinical vendors, and external partners
- Proven experience managing medical device clinical programs from study start-up through execution and close-out
- Experience with multiple clinical study models, including multicenter, decentralized, and hybrid clinical trials
- Strong knowledge of FDA clinical trial requirements, Good Clinical Practice (ICH-GCP), ISO 14155, and applicable clinical research regulations
- Demonstrated experience providing sponsor oversight of medical device clinical studies
- Experience developing and managing clinical study budgets, timelines, enrollment forecasts, resources, and operational plans
- Experience supporting clinical evidence generation for regulatory submissions
- Strong understanding of clinical study documentation, data quality, safety reporting, monitoring, and inspection-readiness requirements
- Proven ability to identify and mitigate clinical program risks while managing multiple priorities and studies simultaneously
- Excellent leadership, project management, organizational, and problem-solving capabilities
- Strong written and verbal communication skills with the ability to communicate clinical strategy, study performance, and risks to executive leadership
- Demonstrated ability to effectively collaborate across Clinical Research, Regulatory Affairs, Quality, Product Development, and other functions
Preferred Qualifications:
- Master’s degree or other advanced degree in a relevant scientific, clinical, or technical discipline
- Experience within a startup or growth-stage medical device organization
- Experience supporting pivotal or other clinical studies used for FDA submissions and product approvals/clearances
- Experience generating clinical evidence to support reimbursement, payer coverage, or market access initiatives
- Experience with neurological, neuromodulation, wearable, or connected medical devices
- Experience supporting FDA inspections, clinical site audits, and other regulatory or Quality System inspections
- Experience building or scaling Clinical Affairs functions, processes, and teams
- Experience working with international clinical studies and regulatory requirements
Compensation:
- Base Pay: $240,000–$280,000 per year
Similar jobs
Est. 124,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 124,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 240,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 124,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 85,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 85,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 140,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 76,000 USD
ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with…
Est. 165,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 355,000 USD
Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases o…
Est. 124,000 USD
Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engin…
Est. 140,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 250,000 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 120,000 USD
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, p…
Est. 290,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 270,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…
Est. 290,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 160,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 165,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 189,500 USD
Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases o…
Est. 250,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 205,750 USD
Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is buil…
Est. 140,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 130,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 205,500 USD
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech”…
Est. 357,500 USD
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech”…
Est. 273,800 USD
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech”…
Est. 355,000 USD
“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) a…
Est. 250,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
Who We Are: Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib,…