Senior Vice President, Clinical Development

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: The Vice President, Program Management is accountable for the operational execution of Kailera’s development programs, with a strong emphasis on late-stage development. Reporting to the Chief Business and Operating Officer, this leader will serve as the day-to-day engine of the program management function – ensuring that integrated plans are built, maintained, and executed with rigor. The Vice President will directly manage a team of thee Program Managers (plus additional contract Program Managers) and serve as the cross-functional connective tissue that keeps teams aligned, milestones on track, and risks visible. This role demands a leader who is equally comfortable driving detailed execution and operating at the strategic level alongside functional heads and senior leadership. The ideal candidate brings deep Phase 3 experience, strong team development instincts, and the discipline to build and sustain operational infrastructure in a fast-moving organization. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Own integrated program management across Kailera's development portfolio across all programs, with primary accountability for Phase 3 programs Drive the evolution of Kailera’s program management capabilities toward a portfolio-based framework, providing enterprise-wide visibility into milestones,

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

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: The Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs) Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards Perform detailed review and provide data integrity oversight of data generated at CDMOs Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements Oversee stability programs to support product retest, shelf-life, and expiration dating Contribute to the preparation of data summaries and report

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: As Director, FP&A – Technical Operations, you will serve as the strategic finance partner to Kailera’s Technical Operations organization, partnering closely with leadership across Drug Product, Drug Supply, and Global Supply Chain. You will contribute to Kailera’s budgeting processes and own the financial planning, forecasting, and analysis that underpin our manufacturing and supply chain strategy, including cost of goods sold, capital investments, and third-party manufacturing spend. As the key business partner to Technical Operations leadership, you will lead complex, cross-functional financial initiatives and translate data into insights that inform executive decision-making. This is a highly visible, full-time role based at our Waltham, MA headquarters, offering the opportunity to build financial infrastructure and processes as Kailera scales its manufacturing and supply chain capabilities to bring new obesity therapies to patients. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Partner with leadership across Drug Product, Drug Supply, and Global Supply Chain to develop annual budgets, long-range financial plans, and rolling forecasts for cost of goods sold (COGS), capital expenditures, and operating expenses Serve as the key financial business partner to Technical Operations leadership, tra

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

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