Director, Medical & Regulatory Writing

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/Senior Director, Program Management provides strategic leadership and performs hands-on operational activities supporting cell therapy programs in autoimmune indications. This individual aligns cross-functional teams, manages dependencies and risks, and ensures programs deliver against milestones and organizational objectives. The Director/Senior Director partners closely with Clinical Development, Clinical Operations, Regulatory, Technical Operations and R&D, along with external partners to drive execution of complex preclinical and clinical programs from early development through registrational studies. Key Responsibilities Translate program strategy into integrated timelines, milestones, and deliverables, ensuring coordination across all contributing functions. Provide program/project management expertise and support to advance Tr1X's Tr1, CAR-Tr1 and in vivo cell therapy programs. Provide program management of one or more highly complex R&D programs and/or high-profile partnerships. Communicate with project team members, management leadership team, department heads, and key stakeholders including KOLs. Track and monitor key milestones and decision points to drive delivery of project objectives. Develop and refine tools for project governance and program timeline

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 Senior Director, Quality (SD) reports to the Chief Technical Officer and is responsible for all aspects of the quality organization including support and oversight for all internal and external GxP operations inclusive of clinical quality assurance (CQA). As the leader of the quality function, the SD establishes and maintains a culture of quality across the organization and is responsible for overseeing development, implementation, and continuous improvement of all quality systems to ensure that all products, processes, and operations comply with applicable regulatory requirements. The SD is ultimately responsible and accountable for critical decisions that directly impact product integrity, patient safety, regulatory compliance, and business continuing. The SD works with both internal and external stakeholders to manage timelines, meet internal deliverables and develop a best-in-class quality organization. This position develops, leads, and coaches the teams responsible for quality systems, quality control, document control, quality assurance, clinical quality, and compliance. The SD responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with applicable GxPs. Additional responsibilities include team building, ca

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 Senior Scientist, In vivo Immunology – Targeted LNP Delivery is an experienced, hands-on immunologist who leads the biological design and evaluation of targeted lipid nanoparticle (tLNP) formulations supporting the Tr1X in vivo chimeric antigen receptor (CAR)-Treg platform. Reporting to the Executive Director of Biology, this individual plays a central R&D role in advancing tLNP delivery systems — defining the immunological targeting rationale and driving in vitro and in vivo proof-of-concept studies — to enable precise, immune cell-specific delivery of nucleic acid payloads. This is a high-impact, science-driven role focused on the discovery and development of Tr1X’s next-generation tLNP delivery platform. The Senior Scientist brings deep expertise in immunology, particularly T cell and Treg biology, hands-on experience applying tLNPs in immune cells, strong experimental rigor across in vitro and in vivo studies, and the ability to thrive in a fast-paced startup environment. Key Responsibilities Partner with formulation and chemistry colleagues on the design and optimization of targeted lipid nanoparticle (tLNP) formulations for mRNA payloads, owning the immunological targeting criteria and biological evaluation. Design and execute in vitro and in vivo studies, including humanized models,

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: We are seeking an experienced, highly motivated Senior Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Responsible for medical monitoring/reporting and safety activities Provide strategic medical leadership in the design, planning, and execution of clinical development strategies across multiple studies Acts as the medical contact at the company for clinical/medical issues Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel Serves as the medical expert for assigned assets studies Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution Oversee and support data interpretation, analysis, and clinical study reports

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 differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Associate Director/Director, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director, Biostatistics, the Associate Director/Director, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs). Additionally, the Associate Director/Director, Biostatistics will manage Contract Resource Organization (CRO) partners in the creation of statistical outputs, with hands-on quality checks of the outputs. This role will contribute to Clinical Study Report (CSR) writing, and regulatory submission documents. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully r

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, reimburse