Senior Scientist, Analytical Development and Quality Control

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: This is a critical leadership role within the medical organization. The Head of Clinical Development leads the development, execution, and communication of the global medical and scientific evidence generation strategy for our products. They solicit and incorporate cross-functional input into this strategy, translate it into an aligned vision and actionable global development plan, and are accountable for its execution. They develop key external scientific relationships with leaders in the obesity research and medical community, interact with global regulatory authorities, and work cross-functionally within the medical organization and throughout Kailera. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Build, grow, and lead the global clinical development organization Develop and execute global development strategy and resultant evidence generation plan with incorporation of cross-functional and regional input Design, execute, complete, and communicate clinical trials (eg, scientific advisory boards, protocol development, regulatory and ethic committee interactions, medical monitoring, data analyses, study reports, regulatory correspondences and filings, presentations, and data dissemination) Deliver robust clinical trial data on-time and on-budget to inform product benefit: risk Interface with globa

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: 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

What You Will Achieve As a Senior Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member whose decisions impact the projects. You will perform qualitative and quantitative analyses of organic and inorganic compounds to determine chemical and physical properties during chemical syntheses, or drug product development process. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members. It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It This colleague will be responsible for developing analytical strategies in support of pharmaceutical drug substance and/or drug products during all development phases, including supporting manufacturing process development, developing, validating and transferring analytical methods, designing stability studies for shelf life assignments, and developing impurity control strategies. Collaborates with colleagues and subject matter experts to assess the most appropriate analytical approach to support project activities, including use of computational predictive tools, modelling software and data visualization tools where appropriate. Perform lab work and delegate responsibilities and review peer lab work as appropriate, Through effective communicat

POSITION SUMMARY: Natera is a global leader in cell-free DNA testing. We measure fetal, tumor, or donor cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test. The Natera R&D Department is looking for a highly motivated Senior Scientist to join the rapidly growing assay development team to help build the future of Natera. In this position, you will be an integral part of high-performing teams across functions to develop laboratory tests that positively impact the business and our patients. A successful candidate will have a deep understanding of molecular biology, strong scientific curiosity and high level of expertise of developing cfDNA assays through product development cycles. You will lead and support dedicated junior scientists and laboratory technicians to plan, execute and manage scientific studies under design control in a regulated environment to help improve and expand Natera's state-of-the-art product portfolios. PRIMARY RESPONSIBILITIES: Lead technical projects and associated timelines and deliverables as a subject matter expert and represent the assay development group in cross-functional project teams. Drive the planning, design, execution, and reporting of feasibility, development, verification and validation studies under the design control quality system. Collaborate closely with research scientists, automation engineers, biostatisticians and data scientists within a dynamic R&D team to develop new and innovative molecular assays. Communicate and document experimental data, scientific findings, and recommendations to R&D and other functions including Lab Operations, Scientific Affairs, Product Management, Quality, and Regulatory groups. May manage Research Associates. QUALIFICATIONS: Typically requires a university degree and a minimum of 8+ years of related experience or a MS degree and 6 years of related experience or a PhD and 4 years of related experience Knowledge of high throughput