Senior Technical Program Manager for Enterprise Software & Clinical Solutions
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Senior
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About Q Bio
Q Bio is at the forefront of transforming preventive medicine. We collaborate with clinics and healthcare systems to implement advanced longevity initiatives powered by our unique Q Exam. Our approach integrates whole-body MRI and biomarkers to provide a clinically rigorous understanding of health and early disease detection. Our goal is to make precision prevention scalable while alleviating operational burdens, establishing us as pioneers in personalized health.
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Search for Executive Director Of Clinical Regulatory Affairs
47 results
Vaxcyte, Inc.
Be a Part of Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of vaccine innovation, focusing on the development of high-fidelity vaccines aimed at protecting society from severe bacterial diseases that can lead to significant health challenges. Our commitment to combating bacterial infections, including invasive pneumococcal disease, Group A Streptococcus, and Shigella, positions us as leaders in the field. With a clear and defined path toward success, Vaxcyte is committed to making a lasting impact on global health. Our Approach: Values that Drive Us We believe that our mission is as important as our methodology. Our work is guided by four foundational values: *RETHINK CONVENTION: We embrace creativity and diverse perspectives to continuously innovate the delivery of vaccines. *AIM HIGH: Our ambitious goal is to develop the most complex biologics designed to protect humanity. *LEAD WITH HEART: Collaboration at Vaxcyte is rooted in kindness and inclusivity, fostering an environment where vigorous debate leads to meaningful outcomes. *MODEL EXCELLENCE: Meeting our challenges requires a collective commitment to integrity, accountability, and clarity in communication and decision-making.Position Summary:The Executive Director of Clinical Regulatory is a leadership role responsible for crafting and executing global regulatory strategies for clinical investigations and the commercialization of vaccines across both adult and pediatric populations. Working closely with Clinical Development and Safety teams, this position will provide regulatory oversight that supports the preparation of clinical development protocols, interpretation and summarization of clinical data, and the creation and management of clinical and pre-clinical regulatory documents. This role also entails liaising with regulatory authorities to secure commercial approval for innovative vaccine products.Candidates should possess extensive experience in developing and executing regulatory strategies for vaccines and preparing investigational and commercial regulatory submissions, such as IND/IMPD, BLA/MAA, and post-approval clinical and safety notifications. Strong communication skills are essential, particularly the ability to simplify complex regulatory issues and effectively convey potential options and opportunities.
Vaxcyte, based in San Carlos, California, is a clinical-stage vaccine company working to advance vaccines that address serious bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The team values creative thinking, ambitious goals, kindness, and integrity as it pursues new solutions in vaccine development. Role overview The Associate Director, Regulatory CMC, plays a key role in both strategy and execution. This position develops and implements global regulatory CMC strategies for investigational products. The role involves leading the preparation and submission of regulatory CMC documents, managing communications with health authorities, and guiding cross-functional teams on regulatory CMC matters. Main responsibilities Develop and execute global regulatory CMC strategies for investigational products. Lead the preparation and submission of regulatory CMC documents. Manage communications with health authorities regarding CMC topics. Provide regulatory CMC guidance to cross-functional project teams. Ensure compliance with global regulatory requirements. Conduct ongoing regulatory surveillance to keep the team informed of changes in regulations.
About 1X1X is an innovative AI and robotics company located in Palo Alto, California, dedicated to creating a future with abundant opportunities through the development of autonomous general-purpose robots. Our goal is to enhance society by designing humanoid robots that can seamlessly integrate into our daily lives, learning and evolving alongside us.Role OverviewAs the Director of Product Safety and Regulatory Counsel, you will be at the forefront of ensuring product liability compliance and technical safety for our advanced embodied AI systems. Your role will involve collaborating closely with engineering and safety teams to provide critical legal guidance on risk assessment and deployment strategies, while also shaping how our company communicates its commitment to robot safety to the public. This pivotal legal position is situated at the intersection of AI, robotics, and safety law, playing a key role in defining safe practices for the deployment of intelligent machines within society. You will report directly to the General Counsel.
As a Senior Director of Oncology Clinical Trial Operations at Natera, you will lead and optimize our clinical trial operations in the oncology space, ensuring the successful execution of clinical studies from inception to completion. You'll collaborate with cross-functional teams to develop innovative strategies that align with our mission to improve patient outcomes through precision medicine.Your leadership will be pivotal in managing a team of dedicated professionals, fostering a culture of excellence and continuous improvement. The ideal candidate will possess a deep understanding of oncology clinical trials, regulatory requirements, and an ability to navigate complex project landscapes.
Join Natera as a Senior Clinical Scientist in Oncology, where you will play a vital role in advancing our mission to transform the field of oncology through innovative diagnostics. You will leverage your expertise to drive clinical research projects and collaborate with cross-functional teams to support the development of cutting-edge solutions.
Join Natera as a Lead Clinical Lab Scientist, where you will play a pivotal role in advancing our laboratory operations. We are seeking an experienced and passionate scientist who is ready to lead a team, drive innovation, and ensure the highest quality standards in our clinical laboratory environment.In this role, you will oversee laboratory procedures, mentor junior staff, and collaborate with cross-functional teams to optimize lab performance. Your expertise will be crucial in implementing new technologies and methodologies that enhance our testing capabilities and improve patient outcomes.
Join Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of clinical-stage vaccine innovation, dedicated to developing high-fidelity vaccines aimed at protecting humanity from the serious and costly implications of bacterial diseases. Our commitment to eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella exemplifies our mission. With a clear and well-defined path to success, Vaxcyte is poised to make a significant impact. Our Approach: At Vaxcyte, what we do is as crucial as how we do it. Our collaboration is anchored in four enduring core values: *Rethink Convention: We infuse creativity and diverse thinking into every aspect of our work to continuously innovate how vaccines are delivered. *Aim High: We embrace our bold collective goal to courageously develop the most complex biologics ever attempted to safeguard humanity. *Lead with Heart: Every individual at Vaxcyte leads with a kindness-first, inclusive approach that fosters collaboration and vigorous debate to advance our business objectives. *Model Excellence: The scale of our challenge necessitates a shared commitment to integrity, accountability, equality, and transparency in communication and decision-making.Position Overview:The Associate Director of Quality Control Operations is a pivotal executive role within our global vaccine organization. This position is responsible for implementing Vaxcyte's analytical strategies at our Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs). Acting as the primary liaison for our CDMOs and CROs, you will ensure the delivery of high-quality, accurate, and compliant testing and analytical services. Collaborating closely with the analytical technical lead and various functions—including Analytics, Process Development, Manufacturing Science, Quality Assurance, and Regulatory Affairs—you will provide leadership and oversight for the execution of analytical strategies supporting analytical readiness and deliverables. You will be accountable for ensuring timely and compliant testing and release at our CDMO and CRO, facilitating a secure and uninterrupted supply of Vaxcyte’s groundbreaking therapies.
Natera, Inc.
Role Overview The Lead Clinical Laboratory Scientist at Natera, Inc. in San Carlos, CA, plays a key part in specimen analysis and daily lab operations. This position works closely with the supervisor to meet production goals and maintain high standards in laboratory practices. Main Responsibilities Verify specimen accuracy for patient testing and perform required laboratory tests with precision. Support daily laboratory operations by following standard operating procedures and minimizing errors. Maintain Good Laboratory Practices (GLP), reporting any deviations from protocols to management. Complete production tasks on schedule and process all case samples efficiently. Assist the supervisor with projects assigned by management. Serve as the main point of contact on the lab floor when the supervisor is absent. Train new team members in current laboratory procedures and help implement new processes. Support staff competency evaluations alongside the supervisor and laboratory trainer. Deliver specialized training on laboratory instruments and protocols. Troubleshoot and resolve equipment malfunctions and laboratory errors. Understand the full laboratory workflow and address operational issues as they arise. Ensure correct rollout of new laboratory procedures. Communicate laboratory issues and team concerns to supervisors or managers, offering solutions where possible. Report discrepancies in team performance to the supervisor. Provide constructive feedback during team performance evaluations. Participate in regular meetings with the supervisor. Promote professionalism and maintain team morale, serving as a role model for colleagues. Follow all departmental expectations. Handle Protected Health Information (PHI) in both paper and electronic formats, using various technologies as required. Complete all required HIPAA/PHI privacy, policy, and security training within the first 30 days of employment. Stay current with Natera training requirements. Perform other duties as assigned.
Join Natera as a Lead Biostatistician in Clinical Research, where you will play a pivotal role in the design and analysis of clinical trials. You will collaborate closely with cross-functional teams and contribute to the advancement of innovative healthcare solutions. This is an exciting opportunity to lead statistical programming efforts, ensuring the highest standards of quality and compliance in clinical data analysis.
Natera
Join Natera as a Clinical Lab Supervisor, where you'll lead a team of professionals in a dynamic clinical laboratory environment. In this pivotal role, you will oversee daily laboratory operations, ensuring compliance with quality standards and regulatory requirements. Your leadership will foster a culture of excellence and innovation as you mentor and develop staff, driving continuous improvement in laboratory processes.
Natera
Join Natera as a Clinical Lab Supervisor, where you will lead and manage laboratory operations while ensuring compliance with standards and regulations. This pivotal role involves supervising laboratory staff, maintaining quality control, and collaborating with cross-functional teams to enhance lab efficiency.
Natera, Inc.
Natera, Inc. is hiring a Clinical Lab Scientist I based in San Carlos, CA. This role plays a key part in supporting essential diagnostics by carrying out laboratory tests that directly inform patient care and clinical decisions. What you will do Perform laboratory tests following established protocols Help deliver accurate and timely diagnostic results Uphold quality standards throughout all testing procedures Role impact The work done in this position ensures that patients and clinicians have reliable information for making important healthcare decisions.
Vaxcyte, based in San Carlos, California, develops vaccines aimed at preventing serious bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The company’s mission is to advance vaccine science and help protect communities around the world. The team values fresh thinking, high standards, and open communication. Vaxcyte encourages new ideas to improve vaccine delivery, strives for significant progress in biologics, and emphasizes kindness, inclusivity, and clear communication. Integrity and accountability guide their approach to every challenge. Role overview The Senior Manager of Indirect Procurement for Clinical Development leads procurement efforts that support clinical development programs. This role serves as a strategic partner to Clinical Operations and works closely with Finance and Legal. Responsibilities span the entire procurement process for clinical trials, from project initiation through closeout, and require flexibility as indirect spend categories evolve. Key responsibilities Direct procurement support for clinical development initiatives Oversee the requisition to purchase order process for clinical trials Assist with vendor selection and coordinate contracts to ensure engagements are timely, compliant, and cost-effective Work with Clinical Operations, Finance, and Legal teams throughout the procurement lifecycle
Join Natera as a Clinical Lab Scientist II, where you will play a pivotal role in our laboratory operations, contributing to groundbreaking genetic testing technologies. You will be responsible for performing complex laboratory tests, ensuring accuracy and compliance with all regulatory requirements. Your expertise will help us deliver critical insights and improve patient outcomes.
robust.ai
As the Director of Deployment at robust.ai, you will play a critical role in the successful implementation of our cutting-edge artificial intelligence solutions. You will lead the deployment team to ensure seamless integration of our technologies into client environments, driving operational excellence and delivering exceptional customer experiences.
About Q BioAt Q Bio, we are revolutionizing preventive healthcare. Collaborating with clinics and health systems, we launch cutting-edge longevity programs powered by the Q Exam—a proprietary evaluation that merges whole-body MRI with integrated biomarkers to furnish a clinically robust overview of health and early disease detection. Our mission extends beyond developing tools; we are crafting the data-driven future of personalized health.Your RoleWe are on the lookout for a Senior Technical Program Manager who will drive the successful delivery of Q Bio’s enterprise software and clinical technology initiatives. This pivotal role is responsible for overseeing complex, regulated programs, establishing a clear operational rhythm, identifying risks early, and ensuring disciplined follow-up across diverse teams. Working closely with Product, Engineering, Clinical, Quality, Security, and external stakeholders, the Senior Technical Program Manager will guarantee alignment and progress—infusing structure, visibility, and disciplined execution into multifaceted, cross-functional projects. In light of Q Bio’s evolving nature, this position will not only operate within current parameters but will also contribute to the development of systems, processes, and governance that facilitate predictable, scalable execution as the organization evolves.Key ResponsibilitiesAccountability & ProgressDefine clear ownership, milestones, and success criteria for all programs. Propel disciplined, visible progress and ensure that commitments are achieved or proactively escalated.Operational TransparencyCreate and maintain a comprehensive source of truth regarding program health, encompassing schedules, dependencies, risks, and resources. Offer leadership high-fidelity, decision-ready visibility.Interdependency ManagementProactively identify and manage cross-functional dependencies across Product, Engineering, Clinical, Regulatory, Security, and external collaborators to sustain program momentum.Engineering Force MultiplierOversee coordination, logistics, and follow-through to enhance execution efficiency, enabling engineers and scientists to concentrate on high-impact delivery and innovation.
Robust AI
About You and This Role:Robust AI is an innovative and rapidly expanding startup, established in 2019 by a remarkable team with extensive expertise in robotics, artificial intelligence, and business. We pride ourselves on our collaborative culture, where diverse backgrounds and perspectives are valued. We are on the lookout for passionate individuals who share our enthusiasm for robotics and AI, as we strive to redefine the core principles of robotics and create intelligent, collaborative, robust, safe, flexible, and genuinely autonomous robots.As the Director of Perception, you will spearhead our initiatives in computer vision and sensing, driving the development of resilient, real-world robotic systems. You will be responsible for building and leading a world-class team dedicated to enabling our robots to perceive, comprehend, and engage with intricate, dynamic environments. This role demands a rare combination of technical expertise, strategic foresight, and exceptional leadership skills. You thrive in a fast-paced startup environment and are adept at adapting to evolving challenges.
Vaxcyte, Inc.
Join Our Mission to Safeguard Humanity!At Vaxcyte, we are pioneering vaccine innovations aimed at developing high-fidelity vaccines to combat the dire consequences of bacterial diseases. These diseases pose significant health risks and financial burdens if not addressed. Our commitment extends to eradicating or treating various bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella. We have a clear and strategic path to success, positioning Vaxcyte for long-term achievement. Our Approach: We believe that WHAT we do is equally important as HOW we do it! Our collaborative efforts are underpinned by four enduring core values: *RETHINK CONVENTION: We infuse creative and intellectual diversity into every aspect of our work to innovate and continuously improve the delivery of vaccines. *AIM HIGH: Together, we strive toward an ambitious goal of developing the most complex biologics to safeguard humanity. *LEAD WITH HEART: At Vaxcyte, we foster a kindness-first, inclusive approach to leadership, promoting collaboration and open debate that drives our business objectives forward. *MODEL EXCELLENCE: The scale of our challenges calls for a shared commitment to integrity, accountability, equality, and clarity in our communications and decision-making processes.Position Summary:The Senior Director of Global Logistics and Distribution will oversee the shipping and storage of all Vaxcyte CMC materials, including finished goods, bulk products, and samples. This role encompasses materials for Research, Development, Clinical, and Commercial purposes and will report directly to the Executive Director of Global Supply Chain.Key Responsibilities:Strategic Planning:Formulate and execute a global logistics and distribution strategy that aligns with corporate goals, including network design, transportation optimization, and warehousing operations.Operations Management:Guarantee the efficient, timely, compliant, and high-quality delivery of all materials within scope.Ensure robust pack-out designs with appropriate containers and components to maintain materials at target temperatures and facilitate efficient receipt.Establish strong shipping agreements with CMOs and suppliers to ensure seamless operations.
Vaxcyte, Inc.
Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation enterprise dedicated to engineering high-fidelity vaccines aimed at protecting humanity from the dire consequences of bacterial diseases. Our efforts to eradicate or treat significant bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella, are just the beginning. With a clear and well-defined path to success, Vaxcyte is poised to make a lasting impact. Our Approach is as crucial as Our Mission! We are guided by four core values that shape our collaborative efforts: *RETHINK CONVENTION: We embrace creative and intellectual diversity to innovate and continuously improve vaccine delivery methods. *AIM HIGH: Our audacious goal drives us to develop the most complex biologics ever devised to protect humankind. *LEAD WITH HEART: Collaboration and vigorous debate are fostered through a kindness-first, inclusive approach. *MODEL EXCELLENCE: Our challenge requires a shared commitment to integrity, accountability, equality, and clear communication in decision-making.Position Summary:Vaxcyte is looking for a distinguished Director of Immunoassay Development to spearhead and lead a dedicated analytical function focused on immunoassay development for intricate conjugated vaccines. This role will involve building and managing a laboratory team tasked with the development, maintenance, and continuous enhancement of potency- and antigenicity-based immunoassays to support CMC development from preclinical stages through BLA-stage programs and commercialization.A primary focus for this role will be the stewardship of the VAX-31 MSD immunoassay platform, which has advanced to Phase 3 due to extensive internal leadership in clinical serology, GLP studies, and immunoassay development. The ideal candidate will collaborate closely with the current immunoassay leadership to ensure effective knowledge transfer, maintain scientific and execution excellence, and ensure the long-term sustainability of the immunoassay strategy as accountability transitions into Analytical Development.This is a hands-on scientific leadership position embedded within CMC execution.
Obvio AI
About Obvio AIEvery year, over 7,500 pedestrians lose their lives due to traffic incidents in the U.S., a staggering 70% increase over the last decade. Despite heightened awareness, many cities are still grappling with the challenge of reducing dangerous driving behaviors. Our 'Vision Zero' initiatives are proving inadequate.At Obvio AI, we are dedicated to changing this narrative.We utilize solar-powered, AI-driven cameras to enforce traffic regulations in areas where pedestrians are most at risk, automating enforcement in ways that traditional systems or police forces cannot achieve. Our innovative approach has already resulted in significant reductions in reckless driving, enhancing safety for pedestrians, drivers, and law enforcement alike.Founded by the same team that developed Motive's AI dashcam, we are supported by Bain Capital Ventures and Khosla Ventures. Recently, we secured $22M in Series A funding and are collaborating with some of the most progressive cities in the nation. With substantial revenue, a vast market opportunity, and a strong policy push, we are laying the groundwork for safer streets worldwide.Obvio is on the lookout for its inaugural Engineering Director to spearhead two of our pivotal product teams—Ticketing and Platform—at a crucial juncture in our growth journey. You will be responsible for the core systems that underpin our mission: the portals used daily by law enforcement and drivers, the external integrations with government and processing systems, the payment infrastructure vital to our operations, and the cloud foundation upon which our entire engineering organization relies.Our existing systems were designed for rapid scalability to get us where we are today. Now, with our momentum, it's time to evolve them into robust infrastructure that can keep pace with our ambitions. This role demands a blend of operational excellence and architectural foresight: someone who can ensure smooth operations today while strategically laying the groundwork for tomorrow. If you have navigated engineering through a hypergrowth phase and have the experiences to show for it, we are eager to connect with you.
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