Senior Manager, Data Management in Pharmaceuticals

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 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 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.

About Acadia Pharmaceuticals Acadia Pharmaceuticals focuses on turning scientific discoveries into meaningful treatments for people with neurological and rare diseases. The company’s commercial portfolio includes the first and only FDA-approved therapies for Parkinson’s disease psychosis and Rett syndrome. Acadia continues to expand its pipeline, with mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, as well as earlier-stage research targeting additional unmet needs. Location and Hybrid Work Model This Senior Director of Portfolio Management role may be based in Princeton, NJ, San Diego, CA, or South San Francisco, CA. Acadia uses a hybrid work model, with an average of three days per week in the office required for this position. Role Overview The Senior Director of Portfolio Management shapes and executes the strategic direction of Acadia’s development and commercialization portfolio. Working in a matrixed environment, this leader drives portfolio prioritization across the enterprise, builds cross-functional partnerships, and supports effective decision-making to maximize value. The role requires close collaboration with teams in Finance, R&D, and Commercial to ensure portfolio investments align with scientific goals, market needs, and financial discipline. Key Responsibilities Create and apply portfolio prioritization frameworks that balance scientific innovation, commercial opportunity, and financial impact. Partner with Finance to assess investment scenarios, improve resource allocation, and support financially sound portfolio decisions. Work alongside R&D leadership to align pipeline strategy with overall portfolio objectives, focusing on scientific feasibility and milestone-based progress. Collaborate with Commercial teams to incorporate market insights, competitive analysis, and launch planning into product positioning strategies.

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 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.

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific potential into innovative solutions that significantly benefit underrepresented communities facing neurological and rare diseases globally. Our commercial offerings include the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are at the forefront of developing a new wave of therapeutic innovations with a robust pipeline that encompasses mid- to late-stage programs targeting Alzheimer’s disease psychosis and Lewy body dementia psychosis, as well as earlier-stage programs addressing various unmet patient needs. At Acadia, our mission is to make a tangible difference in patients' lives.We are seeking talent near: Princeton, NJ; San Diego, CAPosition SummaryThe Senior Manager of R&D Learning & Development plays a pivotal role in designing, implementing, and continuously refining onboarding and training strategies, systems training, and learning processes aimed at enhancing scientific, operational, and future-ready capabilities within the Research and Development organization and its pipeline.Primary ResponsibilitiesContribute to the design, implementation, and ongoing enhancement of a comprehensive onboarding and capability-building curriculum that aligns with the dynamic needs of the R&D pipeline, covering discovery, early development, and late-stage programs.Employ experiential learning methodologies to effectively engage adult learners and facilitate successful knowledge transfer.Assist in managing GxP, congress, and data training in collaboration with internal stakeholders.Work collaboratively with R&D subject matter experts to develop focused training on disease areas, modalities, platforms, and pipeline initiatives, including education on investigational assets and emerging scientific advancements.Lead and support training initiatives in partnership with internal stakeholders.Facilitate the management and development of learning modules in collaboration with external vendors.Oversee the creation of advanced, recurrent, and future-focused training materials.

About Acadia Pharmaceuticals Acadia Pharmaceuticals is dedicated to transforming scientific potential into impactful innovations that greatly benefit underserved communities affected by neurological and rare diseases globally. Our diverse commercial portfolio proudly includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are committed to pioneering the next generation of therapeutic advancements, supported by a robust pipeline featuring mid- to late-stage programs targeting Alzheimer’s disease psychosis and Lewy body dementia psychosis, alongside early-stage initiatives addressing additional unmet patient needs. At Acadia, we strive to be the catalyst for change in these communities.This position can be based in Princeton, NJ, or San Diego, CA, with our hybrid work model requiring an average of three days per week in the office.Position SummaryThe Senior Director of Commercial Advanced Analytics & Data Strategy holds a pivotal leadership role tasked with defining, developing, and expanding the analytics capabilities, data strategy, and governance frameworks that empower commercial decision-making throughout the organization. This role ensures the seamless integration of high-quality data, advanced analytics, and AI-driven insights into commercial strategy, planning, execution, and market optimization. The Senior Director acts as a strategic collaborator across functions, translating business priorities into scalable analytics products and platforms while ensuring governance, compliance, and measurable business outcomes.Over time, this position will cultivate and enhance our commercial advanced analytics and data capabilities, establish effective operating models, and outline future talent and capability demands to support our evolving business landscape. The role will closely collaborate with Acadia’s AI team, which provides shared AI expertise across Commercial and R&D, as well as IT teams responsible for enterprise data, infrastructure, and platform enablement.Primary ResponsibilitiesCommercial Analytics Strategy & LeadershipPartner with Commercial leadership to define the advanced analytics vision, strategy, and initiatives that enable decision-making and performance optimization.

Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology company committed to developing groundbreaking cell and exosome-based therapies for rare diseases. Our flagship innovation, Deramiocel (CAP-1002), represents a leading cell therapy currently in late-stage development for Duchenne muscular dystrophy. Leveraging our proprietary StealthX™ exosome platform, we are exploring new avenues in targeted delivery and vaccinology. Each initiative embodies our dedication to advancing scientific boundaries and providing transformative treatments to patients and families in need.The Senior Manager / Manager of Commercial Logistics will spearhead comprehensive commercial distribution operations for Capricor's pharmaceutical products. This role entails overseeing GxP-compliant logistics, managing cold-chain distribution, coordinating third-party logistics (3PL), ensuring serialization, and maintaining DSCSA compliance. The incumbent will guarantee that products are appropriately stored, handled, serialized, and delivered to customers, partners, depots, and distributors in strict accordance with regulatory and quality standards.This leadership position requires collaboration across various functions such as Supply Chain, Quality, Commercial, Manufacturing, CMC, as well as with external logistics and serialization partners to develop and maintain resilient commercial distribution and compliance processes that facilitate product launches and foster commercial growth.

Join our dynamic team as a Senior SAS Programmer, where you will play a pivotal role in the pharmaceutical industry, collaborating with talented programmers, biostatisticians, and clinical data managers to collect, analyze, and report clinical data across phase I-IV clinical development programs.Key Responsibilities:Write detailed specifications for SDTM datasets in accordance with the Study Data Tabulation Model (SDTM) Implementation Guide.Develop specifications for analysis datasets guided by statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide.Create datasets by developing algorithms and writing SAS programs based on the established specifications.Utilize SAS software to produce comprehensive data listings, summary tables, and graphical representations of data.Perform thorough independent checks on data listings, summary tables, and graphs.Facilitate the import and export of SAS data files.Support the data management team in executing data edit checks.Adhere to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, 21 CFR Part 11 regulations, internal Standard Operating Procedures (SOPs), and international regulatory requirements.Contribute to project solutions and assist in generalizing these solutions for the Biostatistics group.Engage with project statisticians and provide guidance to fellow programmers involved in project teams.

Acadia Pharmaceuticals is hiring a Senior Manager, Government Affairs & Policy to join the team in San Diego, California. This role shapes how the company engages with government agencies and influences policy direction, with a focus on supporting patient access and advancing new therapeutics. Key Responsibilities Advocate for policies that align with Acadia’s mission and expand patient access to therapies. Develop and implement communication strategies to support government affairs goals. Track and analyze policy and regulatory developments that could affect the company. Build and sustain relationships with government officials, policymakers, and other important stakeholders. Collaborate with cross-functional teams to ensure company objectives align with public policy priorities. What Success Looks Like Identifying and addressing policy challenges before they escalate. Working effectively with both internal teams and external partners. Communicating complex policy topics clearly and on time, including their potential impact. Maintaining a strong presence in key policy discussions and forums. Who Thrives in This Role Professionals experienced in navigating political and regulatory landscapes. Individuals who take a proactive, solutions-focused approach to advocacy and policy work. Those skilled at building consensus and managing relationships with a range of stakeholders.

Join our dynamic team at Integrated Resources, Inc. as a Quality Assurance Specialist focused on the pharmaceutical industry. In this role, you will play a crucial part in ensuring the highest quality standards in the development and manufacturing of pharmaceutical products. Your expertise will help maintain compliance with regulatory requirements and enhance product safety and effectiveness.

The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS). This position is essential for ensuring that the Quality System effectively supports all phases of drug development, including nonclinical and clinical development, regulatory submissions (IND, NDA/BLA), commercialization, and product lifecycle management.The Quality Operations Manager is tasked with maintaining compliance with relevant GxP requirements (GLP, GCP, GMP), FDA regulations, global standards, and industry best practices. This role also emphasizes readiness for inspections, regulatory submissions, vendor oversight, and the promotion of a quality-centric culture throughout the organization.Key Responsibilities:eQMS Transition:Evaluate current paper-based procedures and devise a comprehensive plan for transitioning to electronic workflows.Ensure data integrity, compliance with Part 11 where necessary, and proper system validation.Facilitate the integration of GxP processes across all functional areas into a cohesive, risk-based framework.Quality System Management:Develop, implement, and uphold procedures for document control, training management, handling deviations and nonconformances, CAPA, change control, risk management, audit management, and complaint handling (if applicable).Coordinate and deliver training on GxP procedures.Support for External Quality Operations: If applicable.Inspection Readiness & Regulatory Interface:Lead inspection readiness initiatives across the organization.Manage regulatory agency inspections (e.g., FDA, EMA, and other global authorities).Oversee the timely and effective development and implementation of CAPAs in response to regulatory findings.Cross-Functional Leadership:Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT, and Commercial teams.Provide training and foster a culture of quality across the organization.Act as a quality advisor to senior leadership.

We are seeking a highly skilled and experienced Director of Supply Chain Management to lead our supply chain operations at Oric Pharmaceuticals. This pivotal role requires a strategic thinker with a proven track record of optimizing supply chain processes, ensuring product availability, and maintaining high standards of quality and compliance.The ideal candidate will be responsible for managing the end-to-end supply chain activities, including procurement, logistics, inventory management, and distribution. You will work closely with cross-functional teams to align supply chain strategies with business objectives and drive operational excellence.

Join Oric Pharmaceuticals as a Regulatory Affairs Manager and play a critical role in shaping our regulatory strategy and ensuring compliance with industry standards. You will be responsible for overseeing regulatory submissions and maintaining communication with regulatory agencies to facilitate the approval and market access of our innovative therapeutics.

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.

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!

About SpringWorks Therapeutics SpringWorks Therapeutics, part of Merck KGaA, Darmstadt, Germany, is a biopharmaceutical company focused on rare tumors. The team develops treatments for patients with significant unmet medical needs. SpringWorks introduced the first and only FDA and EC approved therapy for adults with desmoid tumors, as well as the first approved treatment for adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN). Diversity in backgrounds, cultures, and experiences shapes the company’s approach to solving challenges for patients with rare tumors. Role Overview: Territory Business Manager – San Diego (Remote) The Territory Business Manager (TBM) serves as the main connection between SpringWorks Therapeutics and customers in the San Diego area. This remote role is responsible for driving sales initiatives, achieving revenue goals, and representing the company’s rare disease products. Key Responsibilities Lead sales efforts within the assigned territory Act as the primary contact for customers Execute brand strategies and support revenue objectives Deliver approved clinical information to healthcare professionals Work closely with commercial teams to coordinate activities Promote rare disease therapies and implement programs in compliance with company and industry standards