Senior Data Scientist - Innovation Lab (Remote)

Join Janux Therapeutics as a Senior Manager of Clinical Data Management, where you will oversee the daily operations of our data management activities. In this pivotal role, you will ensure adherence to regulatory standards and industry best practices, enhancing our operational efficiency. You will also collaborate with vendors to support our oncology clinical trials, ensuring the timely delivery of high-quality data management outcomes.We are looking for a proactive and resourceful professional with extensive hands-on experience in data management within oncology indications. Your expertise will be essential in driving our clinical data processes forward.

Join our dynamic team at California Creative Solutions Inc. as a Senior Manager of Data Management in the Pharmaceuticals sector. This full-time role is based in beautiful San Diego and is pivotal in ensuring the integrity and quality of clinical data management for our innovative projects.As a Senior Manager, you will lead the Data Management team, overseeing the design, testing, and implementation of clinical data collection studies. Your expertise will be crucial in managing high-quality data deliverables for regulatory submissions, publications, and due diligence activities in collaboration with Contract Research Organizations (CROs).Key Responsibilities:Collaborate in designing and implementing clinical protocols and data collection systems.Develop and uphold data quality plans.Ensure timely execution of data management timelines for assigned projects.Provide strategic input into protocol designs with a focus on data management.Assist Biostatistics in the evaluation of Statistical Analysis Plans.Identify and resolve data discrepancies using standardized validation systems.Oversee the generation of quality data deliverables for regulatory, publication, and due diligence purposes.Participate in reviewing clinical and regulatory documents to maintain data integrity and quality.Manage projects in collaboration with CROs and lead internal project initiatives.Contribute to the development of standards and process documentation, including SOPs and Work Instructions.Support compliance with industry quality standards and guidelines.Assist in selecting, developing, and evaluating personnel to ensure efficient operations.Engage in the corporate and departmental budget processes and management.Facilitate career development for Data Management personnel.Perform additional duties as required.

Join Acadia Pharmaceuticals as the Associate Director of Clinical Data Management, where you will lead and oversee the clinical data management functions critical to our drug development processes. In this pivotal role, you will ensure data integrity, compliance with regulatory standards, and contribute to the generation of high-quality data for our clinical trials.

Join Iambic Therapeutics as a Senior Clinical Trial Manager in Clinical Operations, where you will take the lead on early-phase oncology studies, overseeing the entire trial process from initiation to completion. You will collaborate closely with teams in Clinical Development, Regulatory Affairs, Biometrics, and external CROs to ensure that trials are executed with the highest quality standards and are ready for inspections in a dynamic biotech environment.In this role, you will be responsible for vendor management, risk assessment, adherence to timelines and budgets, and fostering cross-functional collaboration to guarantee studies meet global regulatory requirements, ICH-GCP standards, and internal SOPs. Reporting directly to the Director of Clinical Operations, this position is based in San Diego, CA.

As a Clinical Trial Manager at Janux Therapeutics, you will be integral to the strategic planning, execution, and management of clinical trials, ensuring the successful progression from study initiation to completion. This role involves overseeing the activities of Contract Research Organizations (CROs), study vendors, and clinical trial sites while collaborating with essential internal stakeholders to guarantee that clinical trial objectives are met on schedule, within budget, and in compliance with regulatory standards, Good Clinical Practice (GCP) guidelines, and internal Standard Operating Procedures (SOPs). Reporting directly to the Director of Clinical Operations, you will be a vital member of the Clinical Operations team, significantly influencing trial strategy and operational excellence in a dynamic, mission-focused biotech environment.

Join Amgen as a Clinical Risk Management Manager in San Diego, where you will play a pivotal role in enhancing patient safety and minimizing clinical risks. You will lead initiatives that ensure compliance with regulatory standards while fostering a culture of continuous improvement.

Join HeartFlow, Inc. as a Clinical Trial Manager dedicated to advancing healthcare innovation along the West Coast. In this pivotal role, you will oversee and manage clinical research projects, ensuring compliance with regulatory standards and protocols while collaborating with multidisciplinary teams. You will drive the planning, execution, and management of clinical trials, ensuring the highest quality of data collection, analysis, and reporting.

Join Becton, Dickinson and Company as a Senior Manager of Technical Product Management for our Cloud Data Platform and Reporting team. In this vital role, you'll leverage your expertise to drive product strategy, facilitate collaboration across various teams, and lead innovative solutions that enhance our data capabilities. Your leadership will be instrumental in aligning technical goals with business objectives, ensuring our products meet the evolving needs of our customers.

Join our dynamic team at Headlands Research as a Senior Clinical Research Coordinator. In this pivotal role, you will oversee and coordinate clinical trials, ensuring compliance with regulatory guidelines while fostering collaboration among research teams. Your expertise will contribute significantly to advancing clinical research and patient care.

Lead Global Drug Safety & Pharmacovigilance OperationsOversee comprehensive pharmacovigilance processes for oncology products, both during clinical trials and post-approval phases.Collaborate with Clinical Research Organizations (CROs) to manage the intake, assessment, processing, medical review, and reporting of Individual Case Safety Reports (ICSRs), ensuring adherence to established procedures and timelines.Guarantee the prompt submission of expedited and periodic safety reports to relevant Regulatory Authorities, Institutional Review Boards (IRBs), clinical investigators, and business partners.Assist in the preparation and submission of Development Safety Update Reports (DSURs), periodic safety reports, and updates to Investigator Brochures (IBs).Create, refine, and implement Safety Management Plans for clinical studies.Support in Clinical Development & Regulatory AffairsContribute to the safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and regulatory submissions (IND/NDA/MAA/CTAs).Review clinical trial safety data and aid in data cleansing for ongoing studies.Engage in periodic safety reviews, signal detection, and risk evaluation activities.Maintain Reference Safety Information for ORIC products and co-administered Investigational Medicinal Products (IMPs).Support launch readiness efforts by developing post-marketing pharmacovigilance processes and managing Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).Assist in preparations for regulatory inspections and audits.Foster Cross-Functional CollaborationEngage in internal Safety Management Teams and governance meetings.Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams.Facilitate safety training for internal stakeholders and investigators.Vendor & Compliance OversightSupport the supervision of pharmacovigilance vendors and service providers.Ensure the implementation and maintenance of Safety Data Exchange Agreements (SDEAs).Assist in the development and upkeep of Standard Operating Procedures (SOPs) and training materials.

Join our dynamic team as a Senior Clinical Consultant in the innovative HealthSight division. This fully remote role allows you to leverage your clinical expertise to enhance patient care and contribute to impactful healthcare solutions. You will collaborate with healthcare professionals, utilizing advanced data analytics to drive results and improve outcomes.

Fate Therapeutics is seeking a dynamic and experienced Senior Manager or Associate Director of Project Management to become a vital member of our Global Business Operations team. In this pivotal role, you will collaborate closely with the Development and Technical Operations departments to oversee the complete lifecycle of intricate projects. This position acts as a crucial bridge between operational execution, program development strategies, and portfolio direction across our clinical stage programs. This is a full-time, exempt position based at our corporate headquarters in San Diego, CA, reporting directly to the Vice President of Global Operations.

About UsAt DLH Corporation, we are committed to enhancing health and national security readiness solutions for federal programs. Our expert team excels in scientific research and development, systems engineering, and digital transformation. We tackle complex challenges faced by both civilian and military clients by harnessing cutting-edge technologies such as artificial intelligence, data analytics, and cloud solutions. With a workforce of over 2,400 dedicated professionals, we believe that “Your Mission is Our Passion,” combining government sector expertise with innovative methodologies to improve the lives of millions.OverviewAs a Senior Program Manager, you will lead all facets of program execution, focusing on meticulous financial management, task oversight, and the effective coordination of various functional teams. This role requires exceptional leadership to synchronize efforts across engineering, technical support, manufacturing, installations, logistics, quality assurance, and field operations, ensuring program objectives are achieved promptly and within budget.ResponsibilitiesDirect and mentor project managers and senior subject matter experts, fostering an environment of innovation, collaboration, and accountability across the team.Ensure the success of programs through effective communication and coordination with stakeholders, while managing risks and resolving issues proactively.

Join Platform Science as a Senior Product Manager for Managed Driver ExperienceLocation: Remote, San Diego, CAAt Platform Science, we are dedicated to connecting everything that moves. Since our inception in 2015, we have established ourselves as an open IoT platform that collaborates with pioneering fleets, application developers, vehicle manufacturers, and equipment providers within the transportation sector. Our goal is to deliver groundbreaking solutions to supply chain professionals worldwide.We pride ourselves on our diverse and engaging workforce, united by a shared belief in the transformative power of innovative ideas. We seek individuals with varied experiences and perspectives to cultivate a company culture that promotes growth through creativity and innovation.Our core values emphasize empathy, thoughtful actions, and a resilient approach to challenges. We encourage transparency as we work collaboratively, recognizing that we are all part of one team, regardless of our backgrounds or responsibilities.About the RoleAs technology increasingly becomes integral to commercial fleets, drivers rely on in-cab displays for navigation, compliance, communication, and workflow. Fleet IT teams require modern tools to manage these experiences at scale. In this role, you will develop a comprehensive product that consolidates fragmented legacy systems into a singular, robust solution that serves as the system of record for hundreds of thousands of managed devices. Our Managed Driver Experience (MDE) product equips fleet IT and operations teams with a unified portal to control all in-cab displays, from aftermarket tablets to OEM-native in-dash screens, handheld scanners, and mobile phones, across their entire fleet.This is a unique opportunity to lead a greenfield project to scale, as we work to merge multiple legacy device and app management systems into a contemporary, multi-tenant web application. You will take the reins of a clear product vision and an active milestone roadmap, overseeing the product's journey from early adopters to general availability, including the transition of customers from legacy platforms. Ultimately, you will shape the future of how Fleet Managers interact with in-cab Driver devices.You will report directly to the VP of Product and collaborate closely with engineering, design, QA, product marketing, and global business units. Additionally, you will coordinate with teams managing shared platform services that the MDE Portal relies upon, such as authentication, entitlements, and core data models.

As the Vice President/Senior Vice President of Clinical Development at Janux Therapeutics, you will play a pivotal role as the strategic clinical leader for our growing autoimmune pipeline. You will be instrumental in shaping our entry into the autoimmune disease arena, utilizing our innovative platform to meet significant unmet medical needs. In this leadership position, you will oversee high-level strategic initiatives and portfolio management, while fostering collaborations with both internal and external stakeholders to ensure clinical integrity through effective medical monitoring.

Join Pacific Health Group as a Data Administrator, where you will play a crucial role in managing and optimizing our data systems. This is an exciting opportunity for detail-oriented individuals who are passionate about data integrity and analytics.Your primary responsibilities will include maintaining databases, ensuring data accuracy, and collaborating with various departments to support data-driven decision-making. If you thrive in a dynamic environment and have a knack for problem-solving, we encourage you to apply!

Important Notice: This role is dedicated to supporting our US Public Sector clients.“Candidates must successfully pass a ServiceNow background screening, including USFedPASS (US Federal Personnel Authorization Screening Standards). This process involves a credit check, criminal/misdemeanor check, and a drug test. Employment is contingent upon passing this screening process. Due to Federal regulations, only US citizens, US naturalized citizens, or US Permanent Residents with a green card will be considered.As a Senior Problem Manager, you will be instrumental in identifying and resolving issues within our customer cloud infrastructure. You will collaborate closely with Development, Infrastructure Operations, and Customer Support teams to manage known errors, reduce impacts, and lead remediation efforts.Key Responsibilities:Conduct thorough root cause investigationsCreate comprehensive root cause analysis documentation for clientsOversee the prioritization, planning, and execution of problem resolutions to optimize outcomes for both the company and our clientsInitiate and implement evidence-based process improvement initiatives across the organizationAssist in designing the Problem Management process, including data modeling, reporting, and policy developmentProvide training, coaching, and guidance to internal teams to promote best practices in problem management organization-wideDeliver presentations on infrastructure issues and trends to various organizational levels

We are seeking a highly motivated Network Management Specialist to join our growing team. In this role, you will be responsible for conducting comprehensive provider data validation to ensure accuracy and compliance within our network management systems. Your analytical skills will play a crucial role in maintaining high-quality data standards that directly impact our operations and service delivery.

Join Janux Therapeutics as the Senior Manager of Pharmacovigilance, where you will lead and manage the pharmacovigilance activities across our innovative programs. In this pivotal role, you will ensure adherence to global safety regulations and play a critical part in the identification, assessment, and dissemination of safety information. Your expertise will contribute to the strategic integration of safety within the drug development lifecycle. As a Senior Manager, you will also act as a vital link between internal teams and external stakeholders, facilitating effective communication and collaboration.