Director of Data Systems and Clinical Programming

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 Progr…

At Alumis Inc., we are on a mission to revolutionize the treatment landscape for patients suffering from autoimmune diseases. Despite the advancements in treatment over the past 20 years, many individuals with immunologic conditions continue to face challenges. Our commitment is to significantly enhance patient outcomes through precision medicine.The Data Systems & Clinical Programming Specialist (Contractor) will play a crucial role in supporting our Data Management (DM) initiatives as part of the Clinical Programming team. This position operates in a fast-paced environment, adhering to industry standards, and will assist with various Data Systems and Clinical Programming tasks across multiple programs under the guidance of the Director and Associate Director of Data Systems & Clinical Programming.

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.

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.

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.

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.

Zipline is looking for a Technical Program Manager to focus on ground systems and operations at its South San Francisco, California location. This role centers on guiding the planning, deployment, and ongoing performance of new ground systems. Key Responsibilities Lead the deployment process for new ground systems, managing each phase from initial planning through launch. Oversee both construction and ongoing service operations related to these systems. Coordinate closely with engineering, operations, and other teams to ensure projects meet schedule and quality standards. Identify and drive operational improvements to sustain strong ground system performance. Collaboration This position works with a variety of teams to coordinate project execution and maintain high standards in service operations.

At Alumis Inc., we are dedicated to revolutionizing the lives of patients afflicted with autoimmune diseases through precision medicine. Despite advancements in treatment over the last 20 years, a significant number of individuals with immunologic conditions continue to endure hardships; our mission is to fundamentally alter these patients' outcomes.We are in search of a highly skilled Senior Clinical Development Medical Director to lead various aspects of our dermatology and autoimmune clinical drug development initiatives, encompassing discovery research, first-in-human trials, proof of concept, and Phase 3 studies. This role will include overseeing one or more studies within our portfolio and collaborating with all cross-functional team members to leverage comprehensive clinical knowledge in successfully advancing clinical programs and the overall asset strategy.

About UsAt insitro, we are at the cutting edge of integrating machine learning into drug development, aiming to uncover clinically actionable insights that address significant unmet patient needs. Our mission is to expedite and enhance the drug development journey, ensuring a seamless transition from platform to pipeline and ultimately to patients.The RoleWe are seeking a (Senior) Director, Project Team Lead (PTL), also referred to as Asset Team Lead (ATL), to spearhead clinical development initiatives. This pivotal role involves leading cross-functional drug development teams from the nomination of preclinical development candidates through Phase 1 and Phase 2 clinical trials, including proof-of-mechanism (POM) and proof-of-concept (POC) studies. The PTL will be responsible for the comprehensive integration of the therapeutic molecule strategy, timeline management, and risk mitigation efforts.Our commitment is to enhance the clinical trial experience for both patients and drug developers. By prioritizing patient needs, we strive to improve the overall drug development process.In this role, you will design and implement innovative, accelerated strategies, leveraging insitro's machine learning capabilities to achieve excellence in drug development and clinical trials.You will report directly to the Chief Scientific Officer, with opportunities for either onsite work (3 days per week) at our South San Francisco office or a hybrid model (approximately 1 week per month). Some travel may be required to engage with relevant medical and health authorities.This is an outstanding opportunity for an experienced PTL who is eager to leverage their expertise in accelerating the drug development process and delivering better therapeutic options to patients in need.

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.

At Alumis Inc., we are dedicated to revolutionizing the treatment of autoimmune diseases through precision medicine. Despite advancements in treatment over the past two decades, many patients with immunologic conditions still experience significant challenges. Our mission is to fundamentally improve outcomes for these patients.Position SummaryWe are actively seeking a highly qualified Senior or Executive Medical Director to spearhead the clinical development strategy for Phase 1 and Phase 2 trials assessing envudeucitinib and A-005, targeting new indications for the expansion of our innovative pipeline. This pivotal role will not only shape our clinical development portfolio from indication selection to proof-of-concept studies but will also establish you as a vital scientific leader collaborating with internal teams, regulatory bodies, and the broader medical community.

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.

Join Kardigan as a Senior Manager of Statistical Programming, where you will lead a dynamic team of statistical programmers to deliver innovative data solutions in clinical research. You will be responsible for overseeing programming activities, ensuring compliance with regulatory standards, and providing mentorship to junior staff.In this role, you will work closely with cross-functional teams to interpret complex data and translate it into actionable insights. Your expertise will drive the development of statistical analysis plans and programming specifications, contributing to the advancement of groundbreaking therapies.

Join AbbVie as the Executive Medical Director for Immunology Clinical Development, focusing on Respiratory and Pulmonary health. In this pivotal role, you will lead innovative clinical strategies and ensure the successful development of therapies that will transform patient care.

About Us Kardigan is a pioneering heart health company striving to revolutionize cardiovascular disease management, making it preventable and curable, and ultimately eliminating it as the leading cause of death globally.Our mission is to develop a range of targeted treatments that simultaneously address the needs of individuals suffering from cardiovascular diseases, leading them to the cures they rightfully deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s leadership team reunites after their successful tenure at MyoKardia, where they discovered and developed mavacamten, the first cardiac myosin inhibitor, culminating in a significant acquisition by Bristol Myers Squibb in 2020. Our cutting-edge discovery and translational research platform, alongside our robust pipeline of late-stage candidates, empowers our industry-leading team to enhance the lives of patients across the globe. At Kardigan, our values drive our work and interactions, ensuring we prioritize patient needs above all. We are committed to authenticity, fostering an environment of acceptance, and igniting curiosity through a willingness to learn. We champion teamwork, striving for excellence with urgency and intentionality while supporting one another in our roles. Above all, we dare to enable the impossible, recognizing that patients depend on us to innovate and advance scientific discoveries. These core values underpin our daily efforts, empowering us to make a meaningful impact. Kardigan is on the lookout for a hands-on, strategic Director of Quality Assurance for Computer System Assurance, Data Integrity, and Digital Health Technologies. This pivotal role will involve establishing and maintaining a modern CSA framework across GxP environments while enhancing data integrity maturity throughout the organization. The ideal candidate will provide quality assurance leadership for outsourced digital health technologies utilized in clinical trials and patient monitoring, ensuring compliance with regulatory standards and safeguarding patient data.

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.

About Us&nbsp;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.&nbsp;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.&nbsp;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.&nbsp;We are inspired by the potential to enable the impossible, ensuring that our work is impactful every day.&nbsp;Reports To:&nbsp;&nbsp; VP, BiometricsLocation: </strong>Princeton, NJ – On-site 4 days per week (Mon to Thurs)&nbsp;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...

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.

The PositionAs the Director of Biostatistics at Maze Therapeutics, you will be pivotal in guiding the clinical advancement of our innovative therapeutic programs. This role involves close collaboration with teams in Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science, ensuring our clinical studies are methodologically sound, data-driven, and impactful.You will be responsible for the biostatistical strategy and execution, overseeing the entire process from study design to regulatory submissions, seamlessly blending hands-on expertise with strategic oversight. Your role will include representing the Biostatistics function in clinical study teams, guiding the interpretation of intricate data, and managing CRO partnerships to guarantee the delivery of high-quality statistical outputs.This position reports directly to the Vice President of Biometrics.Your ImpactLead biostatistical efforts for clinical studies, offering expert insights on study design, endpoints, and statistical methodologies.Oversee the completion of all technical and operational statistical tasks for a portfolio of clinical trials, ensuring the development and review of complex and innovative statistical analysis plans (SAPs).Work collaboratively with cross-functional teams on protocol development, study design discussions, and data interpretation.Partner with Statistical Programming to develop and validate analyses for internal purposes, publications, and regulatory submissions.Supervise CRO execution of statistical tasks, ensuring adherence to timelines, quality standards, and analytical approaches.Represent the Biostatistics department in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparations, and responses to agency inquiries.Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA).Utilize advanced statistical techniques to analyze and interpret clinical, safety, biomarker, and exploratory data.Advise internal and external stakeholders on statistical methodologies, data integrity, model selection, and result interpretation.Lead the integration and analysis of diverse data sources to facilitate the delivery of special projects and statistical analysis plans for assigned products.Review and assess safety reports, biomarker analyses, and other elements of clinical trial monitoring.Enhance statistical software as needed by programming new techniques; stay updated on current and emerging trends in statistical analysis methodologies and tools.Provide biostatistical input into clinical development documentation and scientific publications.

About the RoleAs the Director of Statistics at AbbVie, you will lead a talented team of statisticians in designing and analyzing clinical trials, ensuring the highest standards of statistical rigor. You will collaborate with cross-functional teams to drive innovative solutions that impact patient outcomes.Key ResponsibilitiesOversee statistical methodology development and implementation for clinical research.Guide statistical analysis plans and ensure compliance with regulatory standards.Mentor and develop junior statisticians and promote a collaborative environment.