Associate Director, Real-World Evidence & Epidemiology

Join Our Mission to Safeguard Humanity!At Vaxcyte, we are a pioneering clinical-stage vaccine innovation company committed to developing high-fidelity vaccines aimed at protecting humanity from the severe health impacts of bacterial diseases. Our mission is to eradicate or effectively treat bacterial infections like invasive pneumococcal disease, Group A Streptococcus, and Shigella, and we have a clear and well-defined path to achieving this goal. Our Approach: What we do is as vital as how we do it! Our collaborative efforts are anchored by four core values: *RETHINK CONVENTION: We embrace creative and intellectual diversity, driving innovation and enhancing vaccine delivery methods. *SET HIGH ASPIRATIONS: We strive to tackle the most complex biologics challenges to protect humankind. *LEAD WITH COMPASSION: Our leadership is rooted in kindness and inclusivity, fostering collaboration and constructive debate to meet our business goals. *MODEL EXCELLENCE: We are dedicated to demonstrating integrity, accountability, and clarity in our communications and decision-making processes.Position Overview:Vaxcyte is on the lookout for an Associate Director of Real-World Evidence & Epidemiology to play a pivotal role in advancing and enhancing our epidemiology and real-world evidence (RWE) capabilities throughout the vaccine lifecycle. Joining our purpose-driven team means contributing to the science of prevention across all stages of life. This role presents a unique opportunity to establish a robust epidemiology and RWE function, offering significant ownership, mentorship, and opportunities for growth.This dynamic, hands-on position is ideal for an early-to-mid-career epidemiologist who thrives on both executing tasks and building functions. The role integrates operational leadership (including study start-up, vendor management, and IRB submissions) with scientific execution, encompassing study design, data analysis, evidence synthesis, and interpretation.As this individual progresses, they will evolve into a scientific epidemiology lead, assuming greater responsibility for study design, analytical strategy, and external scientific collaboration.

Role overview Natera is hiring an Associate Director of Biostatistics to join the team in San Carlos, CA. This leadership position oversees a group of biostatisticians and partners with colleagues from multiple departments. The main focus is on designing and analyzing clinical trials that support projects in genomic testing and personalized medicine. What you will do Supervise and mentor a team of biostatisticians Work with cross-functional teams to plan and analyze clinical trials Use statistical programming and analysis methods in healthcare research Contribute statistical data for regulatory submissions Impact This position plays a key role in advancing genomic testing and personalized medicine. The work aims to improve patient care by providing data-driven insights that inform healthcare decisions.

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.

Become a Key Player in Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of vaccine innovation, dedicated to creating high-fidelity vaccines to shield humanity from the severe impacts of bacterial diseases. Our efforts are directed towards eradicating or managing bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella. We have a clear and strategically laid-out path to success, and Vaxcyte is geared up to achieve its ambitious goals. Our Approach: At Vaxcyte, the importance of WHAT we do is matched only by our commitment to HOW we do it. Our work is anchored by four core values: *RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work to pioneer the future of vaccine delivery. *AIM HIGH: We embrace our audacious goal of developing the most complex biologics to protect humanity. *LEAD WITH HEART: Our inclusive, kindness-first approach fosters collaboration and robust debate that drives our business forward. *MODEL EXCELLENCE: The scale of our challenges demands a collective commitment to integrity, accountability, equality, and clarity in our communications and decisions.Position Overview:The Associate Director of SEC Reporting & Technical Accounting will play a pivotal role in the company’s external reporting and technical accounting functions. Reporting directly to the Senior Director of Technical Accounting & SEC Reporting, this position is highly hands-on, taking ownership of the preparation and execution of SEC filings and technical accounting analyses while managing one direct report.This role is best suited for a technically adept accounting professional who thrives in detail-oriented environments, enjoys cross-functional collaboration, and is eager to help establish processes in a rapidly growing public biotechnology firm.Key Responsibilities:SEC Reporting (Hands-On Execution)Lead the preparation of quarterly and annual SEC filings, including Forms 10-Q, 10-K, and 8-K.Prepare and/or review primary financial statements, footnotes, and related disclosures per U.S. GAAP and SEC requirements.

Join Our Mission to Protect Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines that aim to safeguard humanity from the severe health implications of bacterial diseases. We are committed to eradicating or effectively treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella, with a clear and defined path toward success. Our Approach: What we do is just as vital as how we do it! Our collaborative efforts are anchored by four core values: *RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work to innovate and re-innovate vaccine delivery. *AIM HIGH: We embody our ambitious goal to courageously tackle the most complex biologics designed to protect mankind. *LEAD WITH HEART: At Vaxcyte, everyone leads with kindness and inclusiveness, fostering collaboration and spirited debate that drives our business objectives forward. *MODEL EXCELLENCE: The magnitude of our challenge necessitates our collective commitment to integrity, accountability, equality, and clarity in communications and decision-making.Position Overview:The Associate Director of Process Validation and Risk Management will spearhead and facilitate commercial process validation and risk management activities throughout Vaxcyte's comprehensive manufacturing processes. This role is pivotal in shaping technical strategies, executing plans, and coordinating across functions to ensure commercial readiness, regulatory compliance, and effective lifecycle management.The successful candidate will provide leadership to ensure our organization is adept at designing, executing, and communicating process validation and risk management strategies to internal stakeholders, external partners, and regulatory bodies.This position reports to the Senior Director of Process Validation within the Global MSAT organization and collaborates on the overarching validation strategy, with primary accountability for process validation execution and risk management frameworks supporting commercial manufacturing.

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.

Join Natera as an Associate/Assistant Laboratory Director specializing in Organ Health. In this pivotal role, you will be responsible for overseeing laboratory operations, ensuring compliance with regulatory standards, and driving innovation in organ health diagnostics. As part of our dynamic team, you will collaborate with experts across various disciplines to enhance our laboratory processes and improve patient outcomes. Your contributions will directly impact our mission to advance genetic testing for organ health.

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 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.

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.

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.

Innovative Minds Wanted Are you ready to tackle challenges that seem insurmountable? If you thrive on excitement and innovation, we invite you to continue reading. In 2015, we introduced a groundbreaking approach to biotech, resembling a 'moneyball' strategy, that aggregates early-stage academic research and projects under one financial umbrella. This innovative model minimizes risks and fosters scientific innovation, enabling small expert teams to make significant strides. We focus on bridging the gap to groundbreaking advancements in rare diseases, developing transformative medicines for patients with unmet medical needs as swiftly as possible. At BridgeBio, we encourage redefining boundaries, empowering individuals to solve complex problems. If you are a challenger of the status quo, join our team of highly respected professionals and contribute to redefining the future of biopharma. We value curiosity, experimentation, and the ethical use of AI to enhance clarity, speed, and quality. Your RoleThe Associate Director/Director of Translational Biology will spearhead the development, validation, and integration of biomarker strategies within BridgeBio affiliate programs. This role demands a scientifically adept leader capable of designing and validating assays, embedding biomarkers into clinical development, managing vendor collaborations, and effectively communicating results to both internal and external stakeholders. The ideal candidate will operate at the intersection of discovery, preclinical development, and clinical operations, providing essential scientific leadership and operational rigor to expedite program decision-making. This role includes supervisory responsibilities, allowing you to lead scientific initiatives while mentoring a team of scientists and technical staff, offering coaching, career growth opportunities, and resource planning.

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.

Director of FacilitiesAbout AetherfluxAetherflux is at the forefront of addressing the global energy crisis by pioneering the infrastructure necessary for abundant and resilient space-based solar energy. Our dedicated team is tackling one of humanity’s most intricate engineering challenges, committed to revolutionizing power platforms that transform how civilization powers, computes, and connects—bridging the gap from orbit to Earth.Founded by Baiju Bhatt in 2024, inspired by his father’s contributions at NASA Langley Research Center, Aetherflux is driven by innovation. With a B.S. in Physics and M.S. in Mathematics from Stanford, Baiju co-founded Robinhood, now a public entity that has empowered over 20 million Americans to access financial services. To date, Aetherflux has successfully raised $90 million from esteemed investors including Index Ventures, Interlagos, Construct Ventures, Breakthrough Energy Ventures, and Andreessen Horowitz.Our mission is ambitious, demanding extraordinary talent. Our team comprises professionals from leading organizations such as SpaceX, NASA, and the U.S. Navy, all based in San Carlos, CA. If you are eager to tackle complex technical challenges and contribute to building the world's most vital energy company, we invite you to join us.Position OverviewWe are searching for a seasoned Director of Facilities to spearhead the strategy, development, and management of our facilities, which encompass satellite manufacturing areas, cleanrooms, integration and test environments, laboratories, mission operations spaces, and corporate offices. This pivotal role will ensure that our facilities facilitate high-reliability hardware production, comply with aerospace and export control standards, and efficiently scale as we move towards full operational capacity.

Director of Compute SoftwareAbout AetherfluxAt Aetherflux, we are revolutionizing the infrastructure that powers and connects the orbital economy. Our innovative modular satellites harness sunlight in Low Earth Orbit, facilitating a range of integrated applications, including infrared laser energy transmission (space-to-earth and space-to-space), on-orbit high-performance computing clusters (GPU/TPU), and secure, high-bandwidth optical data transport.Traditional energy and data systems are hampered by outdated infrastructure and complex logistics. Aetherflux addresses these issues by enabling direct, on-demand, secure, and scalable energy distribution and data processing from space. This transformative approach will redefine operations both in orbit and on Earth, supporting the burgeoning space industrial base, ISAM (In-Space Servicing, Assembly, and Manufacturing) operations, and mission-critical environments.Founded in 2024 by Baiju Bhatt, inspired by his father's work with NASA Langley Research Center, Baiju holds a B.S. in Physics and an M.S. in Mathematics from Stanford. He previously co-founded Robinhood, which has empowered over 20 million Americans to access the financial system.With $90 million raised from esteemed investors including Index Ventures, Interlagos, Construct Ventures, Breakthrough Energy Ventures, Andreessen Horowitz, and NEA, we are on an ambitious path that requires exceptional talent. Our team comprises professionals with backgrounds from SpaceX, Astranis, NASA, Anduril, and the U.S. Navy, all based in San Carlos, CA. If you are ready to tackle complex technical challenges and be part of a generational energy and infrastructure company, we encourage you to apply.The RoleWe are seeking a dynamic Director of Compute Software to spearhead the architecture, development, and deployment of the software systems that drive our space-based computing platforms.In this pivotal role, you will be responsible for developing and executing the software strategy for onboard compute systems, focusing on real-time control, distributed processing, and high-bandwidth data management in orbit. Your mission will include defining and building robust, high-performance software that operates under stringent latency, power, and reliability constraints.Collaboration is key; you will work closely with hardware, spacecraft, and mission teams to ensure seamless integration between software and the underlying computing platforms. This leadership position offers significant ownership over system architecture, team development, and execution.

About Obvio AIEvery year, over 7,500 pedestrians lose their lives due to vehicular accidents in the U.S., a staggering increase of 70% over the last decade. Despite heightened awareness, numerous cities find it challenging to combat dangerous driving, resulting in inadequate 'Vision Zero' initiatives nationwide.At Obvio AI, we aim to revolutionize this landscape.We utilize solar-powered, AI-enhanced cameras to enforce traffic regulations in areas where pedestrians are most at risk—automating enforcement in ways that traditional systems and police departments cannot. Our innovative approach has already led to significant reductions in reckless driving and enhanced safety for pedestrians, drivers, and law enforcement.Founded by the creators of Motive’s AI dashcam, Obvio is supported by Bain Capital Ventures and Khosla Ventures. With a recent $22M Series A funding round, we are collaborating with some of the most progressive cities across the nation. Backed by meaningful revenue, a vast market, and strong policy support, we are building the intelligence layer for safer streets on a global scale.About the RoleAs the Head of Annotation Operations, you will oversee our annotation and review function from inception to execution as we expand our capabilities.This position will lead a team poised for substantial growth over the upcoming year. You will be responsible for designing and managing workflows, quality assurance systems, training programs, and performance evaluations essential for operating a high-throughput, safety- and compliance-critical operation.Your ResponsibilitiesAnnotation Operations & Workflow Management:Lead the implementation and ongoing enhancement of Obvio's annotation and review workflows for automated traffic enforcement.Translate enforcement requirements and edge cases into comprehensive review guidelines, task specifications, and escalation pathways.Ensure a balance between throughput, accuracy, and consistency in a high-pressure operational context.Organizational Scaling:Develop the operational framework for a rapidly growing review team, encompassing team structure, leadership roles, and quality assurance functions.Oversee recruitment, onboarding, and training programs to accelerate reviewer proficiency.Establish and manage performance assessment systems, including coaching, feedback, and accountability metrics.

Join Our Mission to Safeguard Humanity!At Vaxcyte, we are pioneering innovative vaccine solutions designed to protect humanity from the severe and costly impacts of bacterial diseases. Our commitment extends to addressing critical infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and defined pathway ahead, Vaxcyte is poised for success in the fight against bacterial infections. Our Approach: We Value Both What We Do and How We Do It! Our collaborative efforts are driven by four core values: *RETHINK CONVENTION: We inject creativity and diverse intellect into every aspect of our work, continually innovating the vaccine delivery process. *AIM HIGH: We embrace ambitious goals, boldly tackling the complexities of biologics to safeguard human health. *LEAD WITH HEART: Vaxcyte fosters a culture of kindness and inclusivity, encouraging robust discussions that propel our objectives. *MODEL EXCELLENCE: Our challenges require a unified commitment to integrity, accountability, and clear communication.Position Overview:The Director of Device Development and Commercialization will oversee the VAX-31 drug product, an intricate biological entity consisting of 31 Drug Substances formulated as an adjuvanted suspension Drug Product. The role demands meticulous attention to the development of a pre-filled syringe (PFS) combination product for both clinical and commercial applications. We seek an enthusiastic and skilled professional to lead our Drug Product Development Team through essential development and regulatory milestones, ensuring our product's successful launch and distribution.The VAX-31DP presents unique challenges in production, handling, and testing due to its suspension system. The director will navigate these complexities by managing their team and collaborating within a matrix structure across the broader Drug Product and commercial organization. Furthermore, it is essential to comprehend, manage, and effectively communicate these challenges to regulatory bodies through compelling submissions. Experience in the vaccine sector, particularly with adjuvants, is highly desirable.

Become a Champion for Global Health!At Vaxcyte, we are at the forefront of vaccine innovation, developing cutting-edge vaccines designed to combat the severe and costly impacts of bacterial diseases. Our mission is to eliminate or effectively manage bacterial infections, including invasive pneumococcal disease, Group A Streptococcus, and Shigella. We have a clear trajectory towards success, and Vaxcyte is well-equipped to achieve our ambitious goals. Our Approach: What we do is equally as significant as how we accomplish it! Our collaborative efforts are driven by four core values: *RETHINK CONVENTION: We introduce creativity and diverse perspectives into every aspect of our work to innovate and continuously improve vaccine delivery methods. *AIM HIGH: We strive for excellence with a bold ambition to create some of the most intricate biologics ever developed to safeguard human health. *LEAD WITH HEART: Kindness and inclusivity are at the forefront of our leadership style, fostering collaboration and robust discussions that propel our business forward. *MODEL EXCELLENCE: We share an unwavering commitment to integrity, accountability, and clarity in all our communications and decisions.Position Overview:Vaxcyte is in search of a Senior Director, Product Launch Lead for VAX-31, who will spearhead the strategic planning and execution of our inaugural launch. This pivotal role involves coordinating cross-departmental initiatives from late-stage development through market introduction, ensuring readiness across supply chain, regulatory, medical affairs, and commercial operations. You will collaborate with senior leadership to outline launch strategies, manage timelines, address risks, and synchronize efforts among internal and external stakeholders to successfully introduce our products to the global market.

Join our dynamic team at Artech Information Systems LLC as a Senior Research Associate. In this role, you will be responsible for conducting in-depth research, analyzing data trends, and presenting findings to drive strategic decision-making. You will collaborate with cross-functional teams to support ongoing projects and contribute to innovative solutions within the organization.

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.