Data Systems & Clinical Programming Specialist (Contractor)

Alumis Inc. is at the forefront of precision medicine, dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune diseases. Despite recent advancements in treatment, many individuals with immunologic conditions still face significant challenges. Our mission is to fundamentally improve their health outcomes through innovative …

At Alumis Inc., we are dedicated to revolutionizing the lives of patients battling autoimmune diseases. Despite advancements in treatment over the past two decades, many individuals with immunologic conditions continue to face significant challenges. Our mission is to transform their outcomes fundamentally.The Director of Data Systems (DS) and Clinical Programming (CP) will spearhead the Clinical Programming function within Data Management (DM). This pivotal role reports directly to the VP of Data Management and Clinical Programming.Key Responsibilities: Lead and oversee the Data Systems and Clinical Programming function within DM.Drive the adoption of innovative technology solutions to enhance DM processes, boost efficiency, and improve overall data quality assurance.Take charge of AI-related initiatives within DM.Formulate and execute strategies to optimize data flow, database constructions, and the integration of external technologies.Supervise the validation of the EDC platform, ensuring continuous system optimization.Manage relationships with key external vendors, aligning their efforts with organizational objectives.Guarantee compliance with pertinent data privacy regulations while safeguarding clinical trial data.Ensure timely completion of DS & CP project deliverables, adhering to quality standards and regulatory requirements.Collaborate with cross-functional teams to synchronize data strategy with broader organizational goals.Mentor and develop team members, fostering a culture of continuous learning and professional growth.Oversee all SAS clinical programming requests, standardizing the clinical programming specification development process.Develop and maintain Alumis’ standard CRFs and standard edit checks, including indication-specific standards.Create DS & CP SOPs and Work Instructions.Lead the development and maintenance of standard vendor Data Transfer Agreements (DTAs).Guide the execution of technical initiatives within DM, including the rollout of critical data visualizations and dashboards such as Clean Patient Tracking and data currency.Integrate data analytics within DM to continually enhance current processes.

At Alumis Inc., we are dedicated to revolutionizing treatment for patients suffering from autoimmune diseases. Despite significant advancements in treatment over the last two decades, many individuals facing immunologic conditions still experience challenges. Our mission is to fundamentally alter the outcomes for these patients.We are currently seeking a Clinical Quality Assurance Director (Contractor) to join our team, reporting directly to the Executive Director of GCPQA. This pivotal role involves collaborating with Quality leadership and Study Execution Team members to provide expertise in ICH-GCP/GVP for our ongoing clinical studies. The position requires close interaction with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and various other departments across Alumis.The Clinical QA Director is tasked with ensuring that quality is integrated throughout the entire lifecycle of our clinical programs through comprehensive oversight, evaluation, and monitoring. This includes utilizing risk assessment tools, conducting audits, and implementing risk mitigation strategies. The Director will also play a key role in establishing Key Performance Indicators and Metrics to track the health of our clinical trials.This position entails providing operational quality guidance for development teams and supporting the Executive Director of GCP Quality in shaping the strategy and vision for the Alumis Quality organization.The ideal candidate will possess extensive knowledge of Good Clinical and Pharmacovigilance Practices (ICH-GCP & GVP) along with relevant US and EU regulations. We seek a proactive leader who will champion a culture of ethics, integrity, and quality management. Your guidance will be vital in ensuring that our quality functions meet the rigorous standards set by global regulatory authorities.ESSENTIAL DUTIES & RESPONSIBILITIESEstablish and maintain ICH-GCP Clinical QA programs, policies, and procedures.Ensure compliance of ongoing clinical programs with health authority regulations, guidelines, and internal Standard Operating Procedures.Serve as the primary ICH-GCP Clinical QA expert and point of contact for all related matters and initiatives.Create and maintain study-specific audit plans; conduct audits and lead external quality auditors as necessary.Represent the Quality team on project teams, during Health Authority Inspections, and in operational meetings with service providers and CROs.Provide quality oversight and review of critical Clinical and IND/NDA enabling documents.Review clinical trial documentation to ensure data integrity and compliance.

The OpportunityBecome a pivotal member of Maze Therapeutics as the Director of Data Management. In this influential position, you will formulate and execute the data strategy that underpins our clinical development initiatives. Collaborating extensively with teams in Biostatistics, Statistical Programming, Clinical Operations, and Regulatory Affairs, you will also manage external vendors to ensure the delivery of high-quality, reliable clinical data across our studies.Reporting directly to the Vice President of Biometrics, you will provide strategic guidance and hands-on leadership for clinical data management across various clinical trials. Your contributions will ensure that data is delivered in a timely, compliant, and analysis-ready format, supporting regulatory submissions and critical program decisions.The Impact You’ll HaveLead data management efforts across multiple clinical studies and development phases.Shape and implement data management strategies, standards, and best practices.Mentor and support data management team members, fostering their growth and knowledge sharing.Serve as a subject matter expert for data management processes, systems, and regulatory expectations.Oversee critical study deliverables, including DMPs, CRFs/eCRFs, edit checks, and database locks.Guide accurate, consistent, and timely clinical data collection, cleaning, and reconciliation.Review and approve key study documentation to ensure readiness for analysis and reporting.Drive database lock planning and collaborate closely with Biostatistics and Medical Writing to support analyses and study reports.Manage CROs and external vendors, ensuring clarity regarding timelines, quality expectations, and contractual commitments.Support the evaluation, implementation, and optimization of EDC and data management technologies.Collaborate closely with Clinical Operations, Biostatistics, and other partners across the organization.Provide data management insights for protocols, study design, and operational planning, while proactively communicating risks and mitigation strategies to senior leadership.

We are seeking a dedicated and experienced Clinical Manager to join our team in South San Francisco. In this role, you will be responsible for overseeing clinical operations, ensuring compliance with regulations, and leading a team of healthcare professionals to deliver high-quality patient care.

Join our dynamic team as a Clinical SAS Programmer where you will play a pivotal role in data analysis and clinical trial management. We are seeking a highly skilled individual passionate about leveraging SAS programming to support clinical research initiatives. In this contract position, you will collaborate with cross-functional teams to provide analytical solutions that drive decision-making in clinical studies.

The OpportunityAt Maze Therapeutics, we are committed to harnessing the potential of precision medicine to revolutionize the treatment of both common and rare diseases. As a Clinical Trial Manager (CTM), you will play a pivotal role in leading and executing our clinical trials focused on Chronic Kidney Disease (CKD). This position offers the chance to engage in mid to late-stage clinical studies, collaborate cross-functionally with internal teams and external partners, and ensure the trials are conducted efficiently while adhering to the highest quality standards. If you are passionate about driving innovation and improving patient outcomes, this role may be your next great opportunity.Your ImpactOversee the execution of one or more Phase 2 CKD clinical trials, from protocol development to achieving key corporate and study milestones, including first patient in, interim analysis, database lock, and completion of study reports.Manage relationships with external vendors, including CROs and global investigative sites, ensuring alignment with project goals and timelines.

Job Overview:The Clinical Project Manager (PM) is pivotal in steering asset teams towards the successful execution of research, development, medical, and commercial strategies. This role requires the PM to act as the operational leader, ensuring that all cross-functional deliverables are completed on time, within budget, and to the highest quality standards.Key Responsibilities:Lead comprehensive project management efforts for asset teams, aligning with strategic and operational objectives.Oversee asset strategic planning, program execution, resource allocation, and risk management.Manage alliance programs, contributing to budget forecasts and asset valuation assessments.Facilitate regulatory submission processes for initial market authorizations and supplemental applications.Collaborate with cross-functional teams to ensure successful submission preparations and outcomes.Collaboration and Reporting:The PM will report to the PM Group Lead or Senior Director and maintain key relationships with various internal and external stakeholders to support high-functioning asset teams.

About KardiganKardigan is dedicated to transforming heart health by making cardiovascular disease preventable and curable, aiming to eliminate it as the leading cause of death worldwide.Our mission is to develop a range of targeted treatments simultaneously, ensuring individuals with cardiovascular diseases receive the cures they rightfully deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan has built on their successful track record, including the development of mavacamten, the first cardiac myosin inhibitor, which led to an acquisition by Bristol Myers Squibb in 2020. With an advanced discovery and translational research platform, a robust pipeline of late-stage candidates, and a top-tier team, we are committed to enhancing patient lives. Our core values shape our work culture: we are driven by the needs of patients and their families, committed to authenticity, eager to learn, dedicated to teamwork, and unafraid to pursue innovative solutions that may seem impossible. These principles empower us to make a meaningful impact every day. Position OverviewKardigan is looking for a Senior Manager, Clinical Trial Lead to oversee one of our cardiovascular clinical studies. As a Clinical Trial Lead (CTL), you will be integral to our Clinical Operations team, reporting to the Clinical Operations Program Leader (COPL). The CTL will manage trials at a global level, ensuring effective execution across multiple regions.

AbbVie Inc. is hiring a Senior Manager, Clinical Quality Assurance in South San Francisco. This position plays a key part in shaping and executing quality assurance strategies for clinical trials. The focus is on upholding regulatory compliance and supporting the delivery of safe, effective therapies. Role overview This role oversees the development and rollout of quality assurance plans within clinical research. The Senior Manager works closely with cross-functional teams, guiding them to maintain high quality standards at every stage of clinical development. What you will do Develop and implement quality assurance strategies for clinical trials Ensure all clinical activities meet regulatory requirements Advise and support teams to achieve consistent quality across projects Requirements Experience in clinical quality assurance Strong understanding of regulatory standards for clinical trials Ability to lead and guide cross-functional teams

About AKASAAt AKASA, we are on a mission to revolutionize the healthcare sector through the power of artificial intelligence. As pioneers of generative AI solutions tailored for the healthcare revenue cycle, our goal is to assist health systems in effectively capturing and conveying the comprehensive clinical journey of patients. By streamlining operations, we enable healthcare providers to concentrate on their primary objective—delivering exceptional patient care. Our innovative approach has garnered over $205 million in funding from prestigious investors like Andreessen Horowitz, BOND, and Costanoa Ventures.This is an exhilarating time to join AKASA, as revenue bookings for our new AI-native product suite have surged over 20 times since its launch in 2024. We have consistently shattered records, achieving the largest deal in our company's history three times in a row. This remarkable growth is fueled by the significant enhancements we are providing our customers in clinical quality and documentation accuracy—key priorities for health system leaders.Our deployments have gained national recognition as "one of the most comprehensive real-world applications of GenAI in healthcare finance to date" (link). Our clientele represents over $120 billion in net patient revenue and includes some of the most innovative health systems across the nation, such as Cleveland Clinic, Duke, Stanford, and Johns Hopkins.Recent accolades include being recognized as the #1 most promising healthcare RCM startup of 2025 by Black Book Market Research and one of the fastest-growing GenAI startups to watch by AIM Research. Our CEO has been honored as one of the “Top 50 Healthcare Technology CEOs” by the Healthcare Technology Report, and for five consecutive years, we have been certified as a “Great Place to Work.”We are harnessing this momentum to redefine the possibilities within healthcare and are seeking exceptional individuals to help us accelerate this vision.About the RoleAs a Senior Product Manager, you will be responsible for overseeing one of AKASA's flagship products within our Clinical Documentation and Medical Coding suite.This suite enhances physician documentation quality, aids clinicians in identifying overlooked diagnoses, transforms documentation into medical codes, and ensures financial accuracy, thereby improving the overall efficiency of healthcare delivery.

Join Veracyte, a pioneering leader in genomic diagnostics, as a Clinical Research Associate. In this dynamic role, you will be integral to the design, execution, and management of clinical trials. Your expertise will help drive the development of innovative tests that enhance patient care.

About Us: Calico Life Sciences LLC, founded by Alphabet, is a pioneering research and development organization dedicated to leveraging cutting-edge technologies and innovative model systems. Our goal is to deepen our understanding of the biological processes governing human aging. By harnessing this knowledge, we aim to create interventions that empower individuals to enjoy longer, healthier lives. With our state-of-the-art technology labs and a dedicated commitment to curiosity-driven scientific exploration, alongside vibrant collaborations with academic and industry partners, we are at the forefront of groundbreaking medical advancements. Position Overview: The Associate Director of Clinical Science will play a crucial role in the strategic planning and implementation of translational and clinical development protocols across multiple therapeutic areas, aligning with Calico's mission to enhance human healthspan by exploring aging and age-related conditions. The ideal candidate will lead the development of innovative clinical strategies for designated programs, fostering a positive and collaborative team atmosphere. Key Responsibilities: Collaborate with the Head of Clinical Science and Medical Directors to lead or represent the Clinical Science function in cross-functional teams focused on executing clinical development plans that translate preclinical data into human studies targeting novel aging-related therapies. Draft and refine clinical sections of protocols from Phase 0 to Phase 2, working closely with interdisciplinary teams including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing. Contribute to the design and execution of experimental medicine studies aimed at demonstrating proof-of-mechanism for innovative targets in aging and related diseases. Engage with academic investigators to support the execution of Investigator-initiated trials. Review and contribute to critical study documents, such as Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, and IND/CTAs. Provide training to CROs and study site personnel on assigned protocols, addressing queries as they arise. Participate in the assessment and selection of CROs and study vendors.

We are seeking a dedicated Clinical Pharmacist to join our dynamic healthcare team in South San Francisco. In this role, you will play a crucial part in patient care by providing comprehensive medication management, collaborating with healthcare professionals, and ensuring optimal therapeutic outcomes. The ideal candidate will be passionate about enhancing the quality of patient care through effective medication therapy management.

At Alumis Inc., we are on a mission to revolutionize the treatment landscape for patients suffering from autoimmune diseases. Despite the advancements made in the last twenty years, many individuals with immunological disorders still face challenges in their treatment journeys. Our aim is to drastically improve outcomes for these individuals.We are currently looking for a Director of Clinical Pharmacology and DMPK who will spearhead the clinical pharmacology strategy and pharmacokinetics/pharmacodynamics (PK/PD) modeling for our small-molecule programs targeting immune-mediated diseases. This pivotal role will involve close collaboration with cross-functional teams and will report directly to the Head of Clinical Pharmacology and DMPK.Key Responsibilities Include:Formulate and lead clinical pharmacology strategies, including dose selection and PK/PD biomarker planning across various stages of program development.Conduct and interpret pharmacokinetic (PK), PK/PD, exposure–response, and simulation analyses utilizing platforms such as NONMEM, WinNonlin, R, Python, and Simcyp.Integrate translational and nonclinical PK/PD data to inform first-in-human (FIH) dose projections and drug-drug interaction (DDI) assessments.Oversee bioanalytical contract research organizations (CROs) to ensure the delivery of high-quality PK/PD and biomarker data in compliance with GLP/GCP standards.Collaborate with Clinical Operations on sample management and protocol design.Effectively communicate quantitative findings and contribute to regulatory documentation, including protocols, Investigator's Brochures (IBs), Investigational New Drug applications (INDs), New Drug Applications (NDAs), and Investigational Medicinal Product Dossiers (IMPDs).Work collaboratively with Clinical Development, Biostatistics/Data Science, Nonclinical teams, and Program Management.

Role Overview Maze Therapeutics is hiring a Senior Clinical Trial Specialist in South San Francisco, CA. This position centers on clinical trials for Phenylketonuria (PKU). The role calls for hands-on oversight and process improvement across trial activities. What You Will Do Oversee clinical trial operations related to PKU therapies Monitor trial progress and support process improvements Ensure compliance with regulatory and quality standards Work closely with cross-functional teams to maintain trial excellence About Maze Therapeutics Maze Therapeutics develops new therapies for genetic diseases. The team values expertise, collaboration, and a commitment to advancing patient care.

At Alumis Inc., we are dedicated to revolutionizing the lives of patients suffering from autoimmune diseases through precision medicine. Despite recent treatment advancements, many individuals continue to endure challenges related to immunologic conditions. Our mission is to fundamentally improve patient outcomes.We are in search of a proactive and skilled leader to join our IT team as a Senior Manager, IT, R&D Applications (Contractor). In this pivotal role, you will support essential business applications that cater to the corporate needs of our Development and Research teams, including Quality Assurance, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions. Additionally, you will play a crucial role in enterprise-level initiatives. Working closely with various stakeholders, you will manage the implementation, maintenance, and ongoing support of SaaS technologies that enhance operational efficiency and drive business success. The ideal candidate should possess a robust technical background, demonstrate excellent organizational skills, work independently, and embody a positive, solution-oriented mindset. This position reports directly to the Director of R&D Business Partner.

Kardigan seeks a Vice President of Clinical Development for Tonlamarsen (TLA), based either in South San Francisco, CA or Princeton, NJ. This position reports directly to the Chief Medical Officer and is part of the Development department. The role is on-site four days a week, Monday through Thursday. Role overview This leadership position focuses on guiding the clinical development of Tonlamarsen (TLA), a key candidate in Kardigan’s late-stage pipeline. The Vice President will play a central role in advancing targeted therapies for cardiovascular disease, supporting Kardigan’s mission to transform heart health and improve patient outcomes. Work environment The role is embedded in a team known for its track record in cardiovascular drug development, including leadership with experience from MyoKardia and the successful development of mavacamten. Collaboration, urgency, and a patient-centered approach shape daily work. The company values authenticity, curiosity, and team success, aiming to achieve significant impact for patients with cardiovascular conditions. Location and schedule South San Francisco, California or Princeton, New Jersey On-site presence required Monday through Thursday

About ZiplineAre you ready to make a difference? At Zipline, we are revolutionizing the movement of goods. Our mission is to tackle the world's most pressing access challenges by developing the first instant delivery and logistics system that serves all individuals equitably, no matter their location. We have powered Rwanda's national blood delivery network, supported Ghana's COVID-19 vaccine distribution, facilitated on-demand home delivery for Walmart, and enabled healthcare providers to deliver care directly to homes across the U.S. Our technology is intricate, but our vision is clear: a teleportation service that delivers exactly what you need, when you need it. By leveraging advanced robotics and automation, we are not only decarbonizing delivery but also alleviating road congestion, reducing fossil fuel dependency, and minimizing air pollution. Our goal is to provide equitable access to billions while establishing a more resilient global supply chain. Join us at Zipline and help fulfill our commitment to creating a fairer and more robust global supply chain for countless individuals.