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Join Artech Information Systems LLC as a Visual Analytics Associate in South San Francisco. In this role, you will leverage your analytical skills to transform complex data into visually engaging reports and dashboards. Collaborate with cross-functional teams to drive insights and enhance decision-making processes.
Join Artech Information Systems LLC as a Visual Analytics Associate in South San Francisco. In this role, you will leverage your analytical skills to transform complex data into visually engaging reports and dashboards. Collaborate with cross-functional teams to drive insights and enhance decision-making processes.
Full-time|$260K/yr - $338K/yr|On-site|South San Francisco, California, United States, Princeton, New Jersey, United States
About Us Kardigan is at the forefront of heart health innovation, dedicated to making cardiovascular diseases preventable and treatable, transforming them from the leading global cause of death.Our mission is to develop multiple targeted therapies that simultaneously address cardiovascular conditions, bringing patients the cures they deserve. Founded by industry leaders including Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., who previously spearheaded MyoKardia and the discovery of mavacamten, Kardigan combines a cutting-edge research platform with a robust pipeline of late-stage candidates, all aimed at improving patient outcomes. Our values—patient-driven, authentic, eager to learn, team-oriented, and innovative—guide our interactions and efforts to make a real difference in the lives of those affected by heart disease. We are inspired by the potential to enable the impossible, ensuring that our work is impactful every day. Reports To: VP, BiometricsLocation: </strong>Princeton, NJ – On-site 4 days per week (Mon to Thurs) Position SummaryThe Head of Data Analytics is a strategic leader responsible for the architectural vision and operational execution of data delivery and advanced insights at Kardigan...
Join our dynamic team as an Analytical Scientist where you will play a pivotal role in driving scientific innovations. In this contract position, you will leverage your analytical expertise to conduct experiments, analyze data, and contribute to cutting-edge projects that impact our future.
Lead the analytical development and product characterization activities for our diverse drug development portfolios independently. Oversee, provide technical guidance, and direct analytical method development, transfer, validation, release, and stability testing activities at contract development and manufacturing organizations (CDMOs). Serve as a subject matter expert for comprehensive physical and chemical characterization of new chemical entities (NCEs) at contract research organizations (CROs).Independently design, conceptualize, and execute experiments while interpreting and presenting data and conclusions to a variety of audiences, including senior leadership. Tackle complex problems utilizing traditional and innovative analytical techniques. Ensure accurate and timely lab records in compliance with good documentation practices and all applicable laboratory, safety, quality, and regulatory standards.Develop and implement strategic project plans for internal and external projects, ensuring that product requirements are accurately designed and delivered on schedule for all stakeholders throughout the drug development continuum—from discovery through preclinical, clinical, and commercial stages. Provide technical support during investigations at CDMOs and CROs in collaboration with quality teams.Author and review technical reports, data packages, and relevant sections for health authority submissions including INDs, NDAs, and annual reports, while supporting due diligence and partnership efforts.Exhibit excellent communication skills in project management, including budget planning, overseeing progress and periodic accruals, and coordinating contracts, purchase orders, and invoices with finance; ensure follow-ups and maintain project timelines to meet high-quality deliverables.
Full-time|$112K/yr - $135K/yr|On-site|South San Francisco
Join Alumis Inc., a pioneering precision medicines company dedicated to transforming the lives of patients suffering from autoimmune diseases. Despite significant advancements in treatment over the past two decades, many individuals with immunologic conditions still struggle; our mission is to fundamentally improve their outcomes.The CMC team at Alumis is on the lookout for a driven and highly skilled Senior Scientist I in Analytical Development. In this role, you will contribute significantly to our research efforts, utilizing your expertise to develop and validate analytical methods, ensuring the quality and efficacy of our innovative therapeutics.
Join AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco as a motivated and experienced Senior Scientist I. In this pivotal role within our Quality Control team, you will focus on early-stage development, from first-in-human trials through Phase 2 clinical studies. The Quality Control team engages in various GxP activities, including change management, document management, coordination of outsourced testing, shelf-life evaluations, and preparation of Certificates of Analysis.As a key representative of the QC function on program teams, you will be responsible for drafting quality documents and sections for regulatory submissions. You will work collaboratively with Technical and Quality Subject Matter Experts (SMEs) to ensure QC deliverables are met for the release of GMP drug substances and products, facilitating clinical supply and shelf-life assignments. Additionally, you will be tasked with creating and reviewing change records and quality event records to support GxP activities.Key Responsibilities:Act as a liaison for the QC function on cross-functional program teams.Collaborate with analytical leads to meet release and stability program milestones.Draft quality control documents and regulatory submissions to support clinical supply.Verify data integrity and conduct stability trend analysis using JMP or other statistical software.Prepare and review essential quality control documentation including Certificates of Analysis, method validation reports, and stability protocols.Initiate and oversee change records in partnership with Technical and Quality SMEs and stakeholders.Work closely with document authors and stakeholders across AbbVie locations to ensure timely document workflows.Maintain compliance with SOPs, regulations, and quality standards.Support internal and external audits and inspections.Utilize your expertise in GxP quality system document management, including document formatting, processing in electronic systems, categorization, and approval processes.
Full-time|$232K/yr - $284K/yr|On-site|South San Francisco, CA
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.
Overview:We are in search of a proactive and results-driven individual who takes personal ownership of their work and thrives in a fast-paced environment. Join our innovative team dedicated to the development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T cell (CART) therapies. The ideal candidate will play a key role in developing and qualifying analytical methods essential for the characterization, release, and stability testing of CART products.Responsibilities:- Provide analytical support for clinical-scale non-GMP/GMP IND-enabling manufacturing operations, focusing on the qualification of in-process and release methods, as well as technology transfer internally and externally to support the manufacturing and release of clinical materials.- Contribute significantly to the successful development and execution of advanced analytical methods for the characterization of CART manufacturing processes and products.- Collaborate effectively with team members and stakeholders to understand process/product relationships, enhance product characterization, and identify critical cellular quality attributes.- Demonstrate accountability, strong interpersonal skills, and effective communication with leadership and peers to foster productive interactions and contribute to project technical teams.- Utilize exceptional organizational skills and scientific expertise to establish high-quality laboratory practices, ensuring consistent and accurate test data.- Maintain timely documentation in electronic laboratory notebooks and author or contribute to technical reports related to regulatory filings as necessary.- Regularly present data and strategies to scientists and management in both internal and external venues, as well as publish findings in peer-reviewed journals when appropriate.
Full-time|$217K/yr - $229K/yr|On-site|South San Francisco, CA
About Us: Calico Life Sciences LLC, a subsidiary of Alphabet, is at the forefront of research and development, focusing on understanding the biology of human aging through advanced technologies and innovative model systems. Our mission is to leverage this knowledge to create interventions that promote longer, healthier lives. With cutting-edge technology labs, a commitment to curiosity-driven scientific discovery, and a dynamic drug-development pipeline in collaboration with academic and industry partners, Calico is a vibrant environment for catalyzing medical breakthroughs. Role Overview: We are on the lookout for a Senior Data Engineer to become a key member of our collaborative Engineering team and lead the establishment of the Drug Discovery Data Engineering group. The ideal candidate will be an enthusiastic team player, meticulous, highly organized, and adept at navigating intricate data, software, and scientific challenges. In this role, you will serve as a crucial technical liaison among our Medicinal Chemistry, Automation, Machine Learning, Assay Technology, and Protein Sciences teams. You will oversee projects from initial requirements through to production deployment, engineering high-performance data systems that integrate with our molecular databases (CDD Vault), inventory systems (Mosaic), electronic lab notebooks (Benchling), our internal data warehouse (BigQuery), and our proprietary AI platform. As the inaugural hire for this team, your contributions will be instrumental in shaping data flows, developing web applications for stakeholder engagement, and establishing a progressive engineering culture in this vital growth sector. Key Responsibilities: Project Leadership: Collaborate with scientists across Assay Technology, Medicinal Chemistry, and Protein Sciences to gather requirements, design solutions, and implement production-grade software that enhances data movement and analysis. System Integration: Create and deploy effective integrations between internal pipelines and third-party platforms, particularly involving the CDD molecular database, Mosaic inventory systems, and Benchling ELN. Data Flow Optimization: Develop and refine data flows organization-wide (e.g., facilitating seamless data transitions from Machine Learning to Protein Sciences to Assay Technologies) to expedite the drug discovery feedback loop. Full-Stack Development: Build data systems and internal web applications (utilizing React and Python) to empower stakeholders to review, visualize, and communicate complex scientific data effectively. Mentorship & Leadership: Act as a senior technical advisor within the broader Engineering team.
Join AbbVie as an Associate Director of Innovation, where you will play a crucial role in driving the future of our research and development initiatives. This dynamic position allows you to collaborate with cross-functional teams to identify and implement innovative solutions that enhance our product offerings.
Full-time|$225K/yr - $225K/yr|On-site|South San Francisco
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.
Full-time|$174K/yr - $244K/yr|On-site|South San Francisco, California, United States, Princeton, New Jersey, United States
About Us Kardigan is a pioneering heart health company dedicated to transforming cardiovascular disease into a preventable, treatable condition, aiming to eliminate it as the leading cause of death globally.Our mission is to develop a diverse range of targeted treatments concurrently that will lead to the cures our patients with cardiovascular diseases deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s founders have reunited following their success at MyoKardia, where they facilitated the discovery and development of mavacamten, the first cardiac myosin inhibitor, culminating in the acquisition by Bristol Myers Squibb in 2020. We boast a cutting-edge discovery and translational research platform, a pipeline full of late-stage candidates, and an exceptional team devoted to enhancing patient lives. At Kardigan, our values drive our work, interactions, and achievements. We are patient-centered, fiercely committed to improving lives and prioritizing patient needs. We believe in authenticity, fostering an environment of acceptance through honest leadership. With a curiosity-driven mindset, we encourage innovative thinking and adaptability. We strive for team success, supporting one another in our collective mission with urgency and excellence. Finally, we aim to enable the impossible, taking calculated risks to inspire innovation and advance scientific breakthroughs. Our core values empower us daily to make a significant impact. Position Title: Associate Director (AD), BiostatisticsDepartment: Development - Data ScienceReports To: Director, BiostatisticsLocation: South San Francisco, CA or Princeton, NJ
Join Short Story, an innovative fashion startup, as a Retail Fulfillment Associate. Your role will involve managing warehouse operations, including efficiently picking and packing orders, handling incoming returns, and organizing new inventory. We value a strong work ethic and effective communication skills as we work together in our tight-knit team to enhance the shopping experience for petite women. Be part of our mission to empower confidence in every customer!
Join our dynamic team at Mindlance as an Associate Scientist. In this pivotal role, you will contribute to groundbreaking research initiatives and assist in the development of innovative solutions within the scientific community. Your expertise and analytical skills will help drive forward our mission to advance scientific knowledge and technology.
At Alumis Inc., we are passionate about revolutionizing the treatment landscape for individuals suffering from autoimmune diseases. Our commitment to precision medicine drives us to innovate treatments that significantly enhance patient outcomes, addressing the unmet needs of those living with immunologic conditions.We are currently in search of an experienced Associate Director of Biostatistics to lend their statistical acumen and operational support to both early-stage and late-stage clinical programs. This pivotal role will see you acting as the lead statistician for various studies, collaborating with multidisciplinary teams to facilitate clinical development and informed decision-making through data analysis. You will play an active role in critical deliverables, oversee CRO activities, and mentor junior team members, fostering a culture of excellence within our statistical team.
Cellares is pioneering the development of an innovative Integrated Digital Manufacturing Operations (IDMO) platform aimed at facilitating scalable, GMP-compliant manufacturing of cell therapies. In line with this ambitious vision, we are constructing a cutting-edge enterprise data foundation powered by Databricks. This will serve to unify data across various domains, including engineering, manufacturing, quality assurance, supply chain, finance, and commercial systems. We are in search of a Principal Enterprise Data Architect — a dynamic, hands-on individual who will lead the design, development, and operationalization of our enterprise data platform from the ground up. This role is critical in fostering real-time decision-making, ensuring data governance, and enhancing AI readiness throughout the organization. This multifaceted position demands a startup-style builder, spending approximately 90% of the time in hands-on activities, with the potential to transition into a key leadership role as we scale our data capabilities in alignment with our Global Capability Center (GCC). The ideal candidate should thrive in a fast-paced, mission-driven environment and be eager to tackle a diverse array of challenges as our organization expands.
Full-time|$100K/yr - $120K/yr|On-site|South San Francisco, California, USA
Zipline runs a large autonomous logistics network, delivering medicine, food, and essential goods across four continents. The company’s technology strengthens supply chains and reduces congestion, completing a delivery every 30 seconds and logging over 140 million commercial autonomous miles. Customers include healthcare providers, governments, retailers, and global organizations that depend on Zipline for critical deliveries and expanded economic access. This South San Francisco-based position centers on supporting operations using data and process insights. The Site Operations Process Associate helps build and maintain dashboards, monitors performance metrics, and escalates operational concerns to the right teams. Relocation support is available for those moving to the area. Key responsibilities Develop and maintain dashboards to track operational metrics and performance. Ensure dashboards remain accurate, user-friendly, and relevant to team needs. Refine reporting processes by improving metrics and enhancing data visibility. Who succeeds in this role This position fits someone who is analytical, detail-oriented, and enjoys using data to improve processes and keep stakeholders informed.
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 therapeutic solutions.The Clinical Data Management (CDM) Contractor plays a crucial role in the meticulous management of clinical trial data within a fast-paced environment, adhering to industry standards. This position involves supporting and potentially leading data management activities and deliverables across one or multiple clinical studies.Key Responsibilities:Act as the Data Management Study Lead or provide support for various studies.Represent Data Management in cross-functional meetings as necessary.Ensure timely completion of Data Management project deliverables in line with quality standards and regulatory requirements from study initiation to closure/archival.Effectively manage vendors throughout the study process.Oversee the creation and accuracy of essential Data Management documentation, including eCRF specifications, completion guidelines, annotated CRFs, validation specifications, transfer agreements, and management plans.Conduct comprehensive testing of the eCRF prior to its deployment, including the development of User Acceptance Testing (UAT) plans and scripts.Ensure the accurate development and execution of data integrations among EDC, IXRS, and/or external vendor data sources.Manage and oversee data transfers for assigned studies, including reviewing test data for consistency with transfer agreements.Participate in the review of study documents such as clinical study protocols and statistical analysis plans.Conduct data quality checks as outlined in the validation specifications or Clinical Data Review Plan (CDRP).Review blinded TFL output prior to final database locks.Report query trends and metrics to the Study Execution Team (SET).Contribute to the development of custom report specifications as needed.Maintain DM project documentation in a state ready for inspection.
Full-time|On-site|South San Francisco, California, United States
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.
Full-time|$163K/yr - $172K/yr|On-site|South San Francisco, CA
Who We Are: Calico Life Sciences LLC is a pioneering research and development organization founded by Alphabet, dedicated to advancing the understanding of human aging through cutting-edge technologies and model systems. Our mission is to leverage this knowledge to develop interventions that promote longer, healthier lives. With a vibrant pipeline of drug development, innovative laboratory technologies, and a commitment to curiosity-driven discovery, Calico is a dynamic environment for driving impactful medical breakthroughs. Position Overview: We are on the lookout for a highly skilled and driven Principal Associate Scientist to lead our Biomarker Group in discovering and validating pharmacodynamic, prognostic, and predictive biomarker assays. This role supports a diverse array of clinical programs, including those focused on Neuroscience, Oncology, and aging-related diseases. The ideal candidate will possess over 15 years of experience in translational biology, molecular and cellular biology, and hands-on assay development, bridging the gap between early discovery and clinical development to ensure that our therapeutic candidates are underpinned by solid biomarker strategies. Key Responsibilities: Discovery & Validation: Lead the discovery and validation of pharmacodynamic biomarkers to support the clinical development of drugs with innovative mechanisms of action using preclinical models (both in vivo and in vitro) and human specimens. Assay Development: Spearhead the development, optimization, and qualification of biomarker assays across various platforms. Data Analysis & Interpretation: Conduct thorough analyses to establish pharmacokinetic/pharmacodynamic relationships and benchmark program compounds, utilizing statistical and specialized tools to interpret results from ex-vivo and in-vitro studies, delivering actionable insights for clinical dose selection, and synthesizing complex biological data into concise reports for senior management. Clinical Translation: Manage the technical transfer of validated assays to CROs or internal bioanalysis teams for Phase I/II studies. Strategic Intelligence: Gather and analyze competitive intelligence to guide discovery strategy and provide scenario assessments for high-priority clinical assets. Mentorship: Mentor and manage junior scientists, fostering a culture of technical excellence and scientific inquiry.
Join Artech Information Systems LLC as a Visual Analytics Associate in South San Francisco. In this role, you will leverage your analytical skills to transform complex data into visually engaging reports and dashboards. Collaborate with cross-functional teams to drive insights and enhance decision-making processes.
Full-time|$260K/yr - $338K/yr|On-site|South San Francisco, California, United States, Princeton, New Jersey, United States
About Us Kardigan is at the forefront of heart health innovation, dedicated to making cardiovascular diseases preventable and treatable, transforming them from the leading global cause of death.Our mission is to develop multiple targeted therapies that simultaneously address cardiovascular conditions, bringing patients the cures they deserve. Founded by industry leaders including Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., who previously spearheaded MyoKardia and the discovery of mavacamten, Kardigan combines a cutting-edge research platform with a robust pipeline of late-stage candidates, all aimed at improving patient outcomes. Our values—patient-driven, authentic, eager to learn, team-oriented, and innovative—guide our interactions and efforts to make a real difference in the lives of those affected by heart disease. We are inspired by the potential to enable the impossible, ensuring that our work is impactful every day. Reports To: VP, BiometricsLocation: </strong>Princeton, NJ – On-site 4 days per week (Mon to Thurs) Position SummaryThe Head of Data Analytics is a strategic leader responsible for the architectural vision and operational execution of data delivery and advanced insights at Kardigan...
Join our dynamic team as an Analytical Scientist where you will play a pivotal role in driving scientific innovations. In this contract position, you will leverage your analytical expertise to conduct experiments, analyze data, and contribute to cutting-edge projects that impact our future.
Lead the analytical development and product characterization activities for our diverse drug development portfolios independently. Oversee, provide technical guidance, and direct analytical method development, transfer, validation, release, and stability testing activities at contract development and manufacturing organizations (CDMOs). Serve as a subject matter expert for comprehensive physical and chemical characterization of new chemical entities (NCEs) at contract research organizations (CROs).Independently design, conceptualize, and execute experiments while interpreting and presenting data and conclusions to a variety of audiences, including senior leadership. Tackle complex problems utilizing traditional and innovative analytical techniques. Ensure accurate and timely lab records in compliance with good documentation practices and all applicable laboratory, safety, quality, and regulatory standards.Develop and implement strategic project plans for internal and external projects, ensuring that product requirements are accurately designed and delivered on schedule for all stakeholders throughout the drug development continuum—from discovery through preclinical, clinical, and commercial stages. Provide technical support during investigations at CDMOs and CROs in collaboration with quality teams.Author and review technical reports, data packages, and relevant sections for health authority submissions including INDs, NDAs, and annual reports, while supporting due diligence and partnership efforts.Exhibit excellent communication skills in project management, including budget planning, overseeing progress and periodic accruals, and coordinating contracts, purchase orders, and invoices with finance; ensure follow-ups and maintain project timelines to meet high-quality deliverables.
Full-time|$112K/yr - $135K/yr|On-site|South San Francisco
Join Alumis Inc., a pioneering precision medicines company dedicated to transforming the lives of patients suffering from autoimmune diseases. Despite significant advancements in treatment over the past two decades, many individuals with immunologic conditions still struggle; our mission is to fundamentally improve their outcomes.The CMC team at Alumis is on the lookout for a driven and highly skilled Senior Scientist I in Analytical Development. In this role, you will contribute significantly to our research efforts, utilizing your expertise to develop and validate analytical methods, ensuring the quality and efficacy of our innovative therapeutics.
Join AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco as a motivated and experienced Senior Scientist I. In this pivotal role within our Quality Control team, you will focus on early-stage development, from first-in-human trials through Phase 2 clinical studies. The Quality Control team engages in various GxP activities, including change management, document management, coordination of outsourced testing, shelf-life evaluations, and preparation of Certificates of Analysis.As a key representative of the QC function on program teams, you will be responsible for drafting quality documents and sections for regulatory submissions. You will work collaboratively with Technical and Quality Subject Matter Experts (SMEs) to ensure QC deliverables are met for the release of GMP drug substances and products, facilitating clinical supply and shelf-life assignments. Additionally, you will be tasked with creating and reviewing change records and quality event records to support GxP activities.Key Responsibilities:Act as a liaison for the QC function on cross-functional program teams.Collaborate with analytical leads to meet release and stability program milestones.Draft quality control documents and regulatory submissions to support clinical supply.Verify data integrity and conduct stability trend analysis using JMP or other statistical software.Prepare and review essential quality control documentation including Certificates of Analysis, method validation reports, and stability protocols.Initiate and oversee change records in partnership with Technical and Quality SMEs and stakeholders.Work closely with document authors and stakeholders across AbbVie locations to ensure timely document workflows.Maintain compliance with SOPs, regulations, and quality standards.Support internal and external audits and inspections.Utilize your expertise in GxP quality system document management, including document formatting, processing in electronic systems, categorization, and approval processes.
Full-time|$232K/yr - $284K/yr|On-site|South San Francisco, CA
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.
Overview:We are in search of a proactive and results-driven individual who takes personal ownership of their work and thrives in a fast-paced environment. Join our innovative team dedicated to the development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T cell (CART) therapies. The ideal candidate will play a key role in developing and qualifying analytical methods essential for the characterization, release, and stability testing of CART products.Responsibilities:- Provide analytical support for clinical-scale non-GMP/GMP IND-enabling manufacturing operations, focusing on the qualification of in-process and release methods, as well as technology transfer internally and externally to support the manufacturing and release of clinical materials.- Contribute significantly to the successful development and execution of advanced analytical methods for the characterization of CART manufacturing processes and products.- Collaborate effectively with team members and stakeholders to understand process/product relationships, enhance product characterization, and identify critical cellular quality attributes.- Demonstrate accountability, strong interpersonal skills, and effective communication with leadership and peers to foster productive interactions and contribute to project technical teams.- Utilize exceptional organizational skills and scientific expertise to establish high-quality laboratory practices, ensuring consistent and accurate test data.- Maintain timely documentation in electronic laboratory notebooks and author or contribute to technical reports related to regulatory filings as necessary.- Regularly present data and strategies to scientists and management in both internal and external venues, as well as publish findings in peer-reviewed journals when appropriate.
Full-time|$217K/yr - $229K/yr|On-site|South San Francisco, CA
About Us: Calico Life Sciences LLC, a subsidiary of Alphabet, is at the forefront of research and development, focusing on understanding the biology of human aging through advanced technologies and innovative model systems. Our mission is to leverage this knowledge to create interventions that promote longer, healthier lives. With cutting-edge technology labs, a commitment to curiosity-driven scientific discovery, and a dynamic drug-development pipeline in collaboration with academic and industry partners, Calico is a vibrant environment for catalyzing medical breakthroughs. Role Overview: We are on the lookout for a Senior Data Engineer to become a key member of our collaborative Engineering team and lead the establishment of the Drug Discovery Data Engineering group. The ideal candidate will be an enthusiastic team player, meticulous, highly organized, and adept at navigating intricate data, software, and scientific challenges. In this role, you will serve as a crucial technical liaison among our Medicinal Chemistry, Automation, Machine Learning, Assay Technology, and Protein Sciences teams. You will oversee projects from initial requirements through to production deployment, engineering high-performance data systems that integrate with our molecular databases (CDD Vault), inventory systems (Mosaic), electronic lab notebooks (Benchling), our internal data warehouse (BigQuery), and our proprietary AI platform. As the inaugural hire for this team, your contributions will be instrumental in shaping data flows, developing web applications for stakeholder engagement, and establishing a progressive engineering culture in this vital growth sector. Key Responsibilities: Project Leadership: Collaborate with scientists across Assay Technology, Medicinal Chemistry, and Protein Sciences to gather requirements, design solutions, and implement production-grade software that enhances data movement and analysis. System Integration: Create and deploy effective integrations between internal pipelines and third-party platforms, particularly involving the CDD molecular database, Mosaic inventory systems, and Benchling ELN. Data Flow Optimization: Develop and refine data flows organization-wide (e.g., facilitating seamless data transitions from Machine Learning to Protein Sciences to Assay Technologies) to expedite the drug discovery feedback loop. Full-Stack Development: Build data systems and internal web applications (utilizing React and Python) to empower stakeholders to review, visualize, and communicate complex scientific data effectively. Mentorship & Leadership: Act as a senior technical advisor within the broader Engineering team.
Join AbbVie as an Associate Director of Innovation, where you will play a crucial role in driving the future of our research and development initiatives. This dynamic position allows you to collaborate with cross-functional teams to identify and implement innovative solutions that enhance our product offerings.
Full-time|$225K/yr - $225K/yr|On-site|South San Francisco
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.
Full-time|$174K/yr - $244K/yr|On-site|South San Francisco, California, United States, Princeton, New Jersey, United States
About Us Kardigan is a pioneering heart health company dedicated to transforming cardiovascular disease into a preventable, treatable condition, aiming to eliminate it as the leading cause of death globally.Our mission is to develop a diverse range of targeted treatments concurrently that will lead to the cures our patients with cardiovascular diseases deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s founders have reunited following their success at MyoKardia, where they facilitated the discovery and development of mavacamten, the first cardiac myosin inhibitor, culminating in the acquisition by Bristol Myers Squibb in 2020. We boast a cutting-edge discovery and translational research platform, a pipeline full of late-stage candidates, and an exceptional team devoted to enhancing patient lives. At Kardigan, our values drive our work, interactions, and achievements. We are patient-centered, fiercely committed to improving lives and prioritizing patient needs. We believe in authenticity, fostering an environment of acceptance through honest leadership. With a curiosity-driven mindset, we encourage innovative thinking and adaptability. We strive for team success, supporting one another in our collective mission with urgency and excellence. Finally, we aim to enable the impossible, taking calculated risks to inspire innovation and advance scientific breakthroughs. Our core values empower us daily to make a significant impact. Position Title: Associate Director (AD), BiostatisticsDepartment: Development - Data ScienceReports To: Director, BiostatisticsLocation: South San Francisco, CA or Princeton, NJ
Join Short Story, an innovative fashion startup, as a Retail Fulfillment Associate. Your role will involve managing warehouse operations, including efficiently picking and packing orders, handling incoming returns, and organizing new inventory. We value a strong work ethic and effective communication skills as we work together in our tight-knit team to enhance the shopping experience for petite women. Be part of our mission to empower confidence in every customer!
Join our dynamic team at Mindlance as an Associate Scientist. In this pivotal role, you will contribute to groundbreaking research initiatives and assist in the development of innovative solutions within the scientific community. Your expertise and analytical skills will help drive forward our mission to advance scientific knowledge and technology.
At Alumis Inc., we are passionate about revolutionizing the treatment landscape for individuals suffering from autoimmune diseases. Our commitment to precision medicine drives us to innovate treatments that significantly enhance patient outcomes, addressing the unmet needs of those living with immunologic conditions.We are currently in search of an experienced Associate Director of Biostatistics to lend their statistical acumen and operational support to both early-stage and late-stage clinical programs. This pivotal role will see you acting as the lead statistician for various studies, collaborating with multidisciplinary teams to facilitate clinical development and informed decision-making through data analysis. You will play an active role in critical deliverables, oversee CRO activities, and mentor junior team members, fostering a culture of excellence within our statistical team.
Cellares is pioneering the development of an innovative Integrated Digital Manufacturing Operations (IDMO) platform aimed at facilitating scalable, GMP-compliant manufacturing of cell therapies. In line with this ambitious vision, we are constructing a cutting-edge enterprise data foundation powered by Databricks. This will serve to unify data across various domains, including engineering, manufacturing, quality assurance, supply chain, finance, and commercial systems. We are in search of a Principal Enterprise Data Architect — a dynamic, hands-on individual who will lead the design, development, and operationalization of our enterprise data platform from the ground up. This role is critical in fostering real-time decision-making, ensuring data governance, and enhancing AI readiness throughout the organization. This multifaceted position demands a startup-style builder, spending approximately 90% of the time in hands-on activities, with the potential to transition into a key leadership role as we scale our data capabilities in alignment with our Global Capability Center (GCC). The ideal candidate should thrive in a fast-paced, mission-driven environment and be eager to tackle a diverse array of challenges as our organization expands.
Full-time|$100K/yr - $120K/yr|On-site|South San Francisco, California, USA
Zipline runs a large autonomous logistics network, delivering medicine, food, and essential goods across four continents. The company’s technology strengthens supply chains and reduces congestion, completing a delivery every 30 seconds and logging over 140 million commercial autonomous miles. Customers include healthcare providers, governments, retailers, and global organizations that depend on Zipline for critical deliveries and expanded economic access. This South San Francisco-based position centers on supporting operations using data and process insights. The Site Operations Process Associate helps build and maintain dashboards, monitors performance metrics, and escalates operational concerns to the right teams. Relocation support is available for those moving to the area. Key responsibilities Develop and maintain dashboards to track operational metrics and performance. Ensure dashboards remain accurate, user-friendly, and relevant to team needs. Refine reporting processes by improving metrics and enhancing data visibility. Who succeeds in this role This position fits someone who is analytical, detail-oriented, and enjoys using data to improve processes and keep stakeholders informed.
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 therapeutic solutions.The Clinical Data Management (CDM) Contractor plays a crucial role in the meticulous management of clinical trial data within a fast-paced environment, adhering to industry standards. This position involves supporting and potentially leading data management activities and deliverables across one or multiple clinical studies.Key Responsibilities:Act as the Data Management Study Lead or provide support for various studies.Represent Data Management in cross-functional meetings as necessary.Ensure timely completion of Data Management project deliverables in line with quality standards and regulatory requirements from study initiation to closure/archival.Effectively manage vendors throughout the study process.Oversee the creation and accuracy of essential Data Management documentation, including eCRF specifications, completion guidelines, annotated CRFs, validation specifications, transfer agreements, and management plans.Conduct comprehensive testing of the eCRF prior to its deployment, including the development of User Acceptance Testing (UAT) plans and scripts.Ensure the accurate development and execution of data integrations among EDC, IXRS, and/or external vendor data sources.Manage and oversee data transfers for assigned studies, including reviewing test data for consistency with transfer agreements.Participate in the review of study documents such as clinical study protocols and statistical analysis plans.Conduct data quality checks as outlined in the validation specifications or Clinical Data Review Plan (CDRP).Review blinded TFL output prior to final database locks.Report query trends and metrics to the Study Execution Team (SET).Contribute to the development of custom report specifications as needed.Maintain DM project documentation in a state ready for inspection.
Full-time|On-site|South San Francisco, California, United States
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.
Full-time|$163K/yr - $172K/yr|On-site|South San Francisco, CA
Who We Are: Calico Life Sciences LLC is a pioneering research and development organization founded by Alphabet, dedicated to advancing the understanding of human aging through cutting-edge technologies and model systems. Our mission is to leverage this knowledge to develop interventions that promote longer, healthier lives. With a vibrant pipeline of drug development, innovative laboratory technologies, and a commitment to curiosity-driven discovery, Calico is a dynamic environment for driving impactful medical breakthroughs. Position Overview: We are on the lookout for a highly skilled and driven Principal Associate Scientist to lead our Biomarker Group in discovering and validating pharmacodynamic, prognostic, and predictive biomarker assays. This role supports a diverse array of clinical programs, including those focused on Neuroscience, Oncology, and aging-related diseases. The ideal candidate will possess over 15 years of experience in translational biology, molecular and cellular biology, and hands-on assay development, bridging the gap between early discovery and clinical development to ensure that our therapeutic candidates are underpinned by solid biomarker strategies. Key Responsibilities: Discovery & Validation: Lead the discovery and validation of pharmacodynamic biomarkers to support the clinical development of drugs with innovative mechanisms of action using preclinical models (both in vivo and in vitro) and human specimens. Assay Development: Spearhead the development, optimization, and qualification of biomarker assays across various platforms. Data Analysis & Interpretation: Conduct thorough analyses to establish pharmacokinetic/pharmacodynamic relationships and benchmark program compounds, utilizing statistical and specialized tools to interpret results from ex-vivo and in-vitro studies, delivering actionable insights for clinical dose selection, and synthesizing complex biological data into concise reports for senior management. Clinical Translation: Manage the technical transfer of validated assays to CROs or internal bioanalysis teams for Phase I/II studies. Strategic Intelligence: Gather and analyze competitive intelligence to guide discovery strategy and provide scenario assessments for high-priority clinical assets. Mentorship: Mentor and manage junior scientists, fostering a culture of technical excellence and scientific inquiry.