Director, Clinical Affairs

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). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health. We are seeking an experienced and hands-on Director, Supply Chain & Operations to lead and scale Noctrix Health’s supply chain and operations function. This role will have direct ownership of supply planning, supplier and contract manufacturer relationships, inventory strategy, logistics, distribution, and operational readiness to support the company’s continued growth. The ideal candidate is a strategic operator who is equally comfortable developing long-term supply chain plans and working directly with suppliers, partners, and internal teams to solve immediate operational challenges. This individual will lead and develop the supply chain and operations team while remaining actively involved in planning, supplier management, negotiations, issue resolution, and continuous improvement. This position reports to the Senior Vice President, Product. This is a full-time, hybrid position based in Pleasanton, CA, with a minimum of three days onsite per week Travel is expected to be approximately 25%–30%, including international supplier and partner visits as needed. Responsibilities Own end-to-end supply chain and operations execution for a Class II medical device business, ensuring capacity, quality, service, cost, and supply continuity support the company’s growth objectives Lead and continuously improve supply planning, production planning, inventory management, logistics, warehousing, fulfill

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 building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Senior Manager of Clinical Affairs POSITION SUMMARY: The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits. The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, offering the opportunity to shape clinical strategy for a novel medical robotic platform and to contribute meaningfully to the company’s long-term success. ROLES AND RESPONSIBILITIES: Clinical Strategy and Leadership Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives. Provide expert input into clinical development plans, trial design, and evidence-generation strategies across the product lifecycle. Advise senior leadership

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Job Purpose and Summary: Join a mission-driven organization at a transformative moment in employer-sponsored health care. As Executive Medical Director, Clinical Business Solutions at Aetna, a CVS Health company, you will lead the clinical team that serves as the clinical voice to our Commercial plan sponsors, prospects, and their advisors, demonstrating how Aetna’s clinical capabilities reduce cost, improve population health, and strengthen the member and provider experience. Reporting directly to the Vice President, Chief Medical Officer, Commercial & Innovation, you will direct a national team of clinicians (MD, RN, NP) providing clinical support to Aetna’s National Accounts, Large Group, and Public & Labor businesses, in close partnership with Field and Account teams. You will lead and continuously improve the operations of the team to raise the level and quality of clinical support delivered to the Field, while sharing directly in its external work — including personally cultivating and holding relationships with key brokers, consultants, and plan sponsors. The role is deliberately bidirectional. You will bring the voice of the customer and the producer community back into the organization, partnering with Clinical Operations, Medical Affairs, Commercial Product, and others to ensure our clinical offerings reflect what the market requires. <p

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio. Position Summary The Director, Medical and Regulatory Writing reports to the Vice President, Head of Regulatory Affairs and provides strategic planning, development, review, and delivery of high-quality medical, clinical, and regulatory documentation supporting Tr1X clinical programs. The role is responsible for establishing and executing medical writing strategies across clinical development programs, ensuring the timely preparation of scientifically accurate, regulatory-compliant documentation. The Director drives document quality and operational excellence and collaborates with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, CMC/Technical Operations, and other functions. The position plays a critical role in supporting regulatory milestones and submissions throughout the product lifecycle, while ensuring alignment with applicable regulatory requirements, scientific standards, and corporate objectives. Key Responsibilities Partner with Regulatory to develop and implement the medical writing strategy in alignment with corporate objectives, clinical development plans, regulatory strategies, and program goals. Author (writes & edits) high-quality documents across all program areas as needed such as clinical study protocols, protocol ame

As the Associate/Laboratory Director, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and rare disease testing on platforms including SNP array analysis, NGS, and other methodologies. Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: appropriate test method selection; adequate method verification to determine the accuracy and precision of the test; enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed; PT samples are tested in accordance with the CLIA requirements; PT results are returned within the time frames established by the PT program; PT reports are reviewed by the appropriate staff; corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory; quality assessment and quality control programs are established and maintained; acceptable analytical test performance is established and maintained for each test system; remedial actions are taken and documented when signific

POSITION SUMMARY As the Laboratory Director and one of our Laboratory Directors, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and oncology testing on platforms including SNP array analysis, NGS, and other methodologies. Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Clinical Consultant. The Clinical Consultant is responsible for ensuring: Test reports include pertinent information for test interpretation, and Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: Appropriate test method selection Adequate method verification to determine the accuracy and precision of the test Enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed PT samples are tested in accordance with the CLIA requirements PT results are returned within the time frames established by the PT program P