Advanced Process Analytics Scientist

Iterative Health is at the forefront of healthcare technology and services, driving the evolution of clinical research to enhance patient outcomes. Our Site Network features over 70 premier clinical research sites across both the US and Europe, facilitating the rapid development of innovative gastrointestinal (GI) and hepatology therapies. We are dedicated to the success and expansion of our partner sites through the provision of tech-enabled services. By merging extensive clinical trial expertise with state-of-the-art AI technology, we empower research teams and study sponsors to broaden and accelerate access to transformative therapeutics for patients in need.About the RoleWe are on the lookout for a dynamic and driven Director of Operational Finance & Analytics to become an integral part of our expanding team. In this pivotal role, you will collaborate closely with executive leadership, finance, and operational teams to oversee the operational finance aspects of our growing network of research sites and enhance the company’s enterprise analytics capabilities, ensuring precision, consistency, and governance of critical metrics for a reliable single source of truth.Your contributions will be vital in constructing and scaling our Enterprise Data Warehouse (EDW) and executing Adaptive Insights, utilizing these essential systems to provide dependable reporting and forecasting that supports operational decision-making. This hands-on leadership position offers a unique opportunity to make a significant impact as the company evolves.

Company Overview Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative small molecules aimed at enhancing the quality of life for patients with genetically defined rare diseases. We are steadfast in our mission to provide hope and new treatment alternatives for individuals afflicted by rare hematologic disorders and are actively expanding our pipeline of clinical and preclinical assets. Our flagship clinical asset, pociredir, represents a groundbreaking small molecule engineered to boost fetal hemoglobin expression, offering potential treatment for sickle cell disease and other hemoglobinopathies. We are seeking a dynamic and strategic leader to direct our Analytical Chemistry function as we grow our portfolio of clinical-stage assets. Position Overview In this pivotal role, reporting to the Head of Technical Operations, the Director of Analytical Chemistry will spearhead the formulation and implementation of control strategies for the manufacture of drug substances and products within Fulcrum’s developmental programs. The successful candidate will provide expert oversight of all Quality Control (QC) operations at contract manufacturers for drug substances (DS) and drug products (DP). Responsibilities include collaborating with pharmaceutics on pre-formulation tasks, engaging with Quality Assurance (QA) on Out of Specification (OOS) and Out of Trend (OOT) investigations, managing CMC risks, and assisting Regulatory CMC in drafting essential sections of regulatory submissions. Key Responsibilities Deliver technical leadership to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) for drug substance and product development, incorporating cGMP method development, validation, method transfer, method remediation, data analysis, and reporting to uphold compliance with GCP, GLP, and cGMP standards. Collaborate with cross-functional teams including Drug Substance, Drug Product, QA, and Regulatory CMC to ensure plans are cohesive, phase-appropriate, and timely. Design and oversee stability studies, including managing shelf-life and retest dates, to guarantee uninterrupted clinical supply. Lead and manage strategies for reference standards, in-process controls, and specifications throughout the asset pipeline. Review and approve a diverse array of documents, such as Test Methods, Qualification/Validation Protocols, Specifications, and Reports at CMOs. Generate, review, and authorize documentation related to the control of DS and DP for Regulatory submissions (IND/IMPD and NDA/MAA). Travel to contract manufacturing sites both domestically and internationally to support crucial production milestones and foster strong business relationships.

The Director of Institutional Research and Analytics will spearhead the Office of Institutional Research and Analytics (OIRA), a vital component of the Office of the Provost that empowers Harvard’s leadership through comprehensive institutional data analysis and reporting. OIRA acts as a reliable resource committed to implementing best practices in data integration and translation, thereby supporting a diverse array of university functions.In this influential role, the director will oversee the creation and execution of a strategic portfolio of analytics projects in collaboration with the Associate Provost for Institutional Research and Analytics and the Associate Director for Analytics. The Director will also provide strategic oversight and management of the office's institutional reporting initiatives. Within OIRA, the Director will lead both the Institutional Research and Strategic Analytics teams.Additionally, the Director will engage with stakeholders across the University on institutional research, survey, and analytics consulting projects, leveraging existing data assets and promoting the integration of various data sets while employing robust statistical methodologies.The ideal candidate will possess expertise in research design, statistical analysis, and data visualization, with a proven capacity to convey complex findings to diverse audiences. This position reports directly to the Associate Provost for Institutional Research and Analytics and plays a prominent role within Harvard's analytics community.Key Responsibilities:The Director of Institutional Research and Analytics will hold a crucial position within OIRA by identifying opportunities to enhance efficiency in institutional reporting and managing the office's expanding suite of analytics and consulting projects. Below are the primary focus areas for this role, with the understanding that responsibilities may evolve as OIRA’s portfolio grows.Analytics Strategy Development and ImplementationCollaborate with the Associate Provost and Associate Director for Analytics to formulate an analytics portfolio strategy and establish a technical framework for effective communication.Lead the execution of the analytics strategy.Curate and manage the portfolio of analytics projects, ensuring adherence to scope and timelines.Provide leadership on emerging trends and technologies in institutional analytics.Analytics Consulting LeadershipLead discovery and scoping efforts for new analytics consulting projects.Advise stakeholders on optimal designs for analytics consulting initiatives.Align with stakeholders regarding timelines for project milestones and completion.

As the Director of Accounting Operations at Scholar Rock, you will be at the forefront of our financial strategies, leading a dynamic team to enhance our accounting practices. Your expertise will drive the efficiency and accuracy of our financial operations, ensuring compliance with regulations and supporting our growth objectives. You will collaborate with cross-functional teams, providing insightful financial analysis and fostering a culture of financial accountability.

Role overview The Senior Director of Business Analytics at Scholar Rock will play a central role in shaping the company's analytics strategy. Based in Cambridge, MA, this leader will drive efforts to support business growth and enable data-informed decision-making throughout the organization. What you will do Create and implement analytics strategies that support Scholar Rock’s goals Work closely with teams across the company to move data-driven projects forward Encourage and foster a strong analytics mindset among colleagues Use business analytics expertise to help set strategic direction and find ways to improve how the company operates Location This role is located in Cambridge, MA.

Relay Therapeutics is seeking a dynamic and experienced Director of Analytical Development and Quality Control to lead our analytical efforts in drug development. In this leadership role, you will oversee the development and implementation of analytical methods to support our innovative drug discovery pipeline. You will work closely with cross-functional teams to ensure optimal quality control processes and regulatory compliance.Your expertise will play a critical role in driving our mission to improve the lives of patients through cutting-edge therapies.

Active Site seeks a Director of Operations based in Cambridge. Title and compensation will reflect each candidate’s experience and the responsibilities expected. Please note that visa sponsorship is not available for this role. This position centers on strengthening both organizational and study operations for a nonprofit focused on the intersection of artificial intelligence and biosecurity. The Director of Operations will help shape the organization’s growth, develop scalable processes, and drive efficiency across all areas. Key responsibilities Management of in-person studies: Turn study plans into actionable timelines, assign responsibilities, coordinate participant recruitment, oversee daily activities, facilitate communication, track progress, and lead post-study evaluations for ongoing improvement. Strategic planning and coordination: Oversee quarterly priorities and goal-setting, and implement clear methods for tracking cross-team work, including ownership, timelines, decision-making, and follow-through. Team development and leadership: Guide the hiring process and build a team dedicated to operational excellence. Budget management and financial operations: Develop and manage project budgets and operational plans. Coordinate with external partners in bookkeeping, payroll, auditing, legal, and HR to ensure accuracy and timeliness. Daily operations and culture: Maintain smooth day-to-day operations and foster a collaborative, results-oriented culture grounded in truth-seeking, drive, and care. What success looks like Within 3–6 months, establish a reliable system for project tracking and updates, including templates for meeting notes, action items, Gantt charts, and straightforward reporting. Learn more about Active Site’s mission and work at https://www.activesite.bio.

Join Harvard University as the Director of Operations in the Campus Services - Harvard Dining & Hospitality department. This pivotal role will oversee the operations of dining and hospitality services, ensuring the highest standards of service and efficiency. The Director will lead a team, develop operational strategies, and drive initiatives that enhance the overall experience of our campus community.

We are seeking a highly motivated and experienced Director of Operations to join The People Lab at Harvard University. In this pivotal role, you will lead operational strategies, manage resources, and ensure the seamless execution of projects that enhance our research capabilities. Your expertise will drive innovation and efficiency across our operations, positioning us as a leader in the field.

Join Amylyx Pharmaceuticals as the Senior Director of Trade and Channel Operations, where you will lead strategic initiatives to optimize our trade and channel strategies. In this pivotal role, you will be responsible for driving operational excellence, enhancing partnerships, and ensuring the effective distribution of our innovative therapies. Collaborate with cross-functional teams to develop and implement best practices that amplify our market presence and improve patient access to our products.

AbbVie is seeking a highly skilled Associate Director to lead our Safety Operations Portfolio. This pivotal role involves overseeing safety operations while ensuring compliance with regulatory requirements. The ideal candidate will possess exceptional leadership skills and a strong background in pharmacovigilance.Join our dynamic team and contribute to advancing healthcare solutions that enhance patient safety and improve health outcomes. This is an exciting opportunity for professionals looking to make a meaningful impact in the pharmaceutical industry.

Nuvalent seeks an Associate Director of Clinical Operations to join the team in Cambridge, MA or work remotely. This leadership role guides the execution of clinical trials, ensuring every step aligns with regulatory standards and internal protocols. The position partners with cross-functional teams to develop and deliver on clinical strategies, overseeing studies from planning through closeout. What you will do Direct clinical trial operations for multiple concurrent studies Maintain compliance with all regulatory requirements and company procedures Work closely with colleagues across departments to create and implement clinical strategies Supervise all aspects of study management, from initiation to completion Oversee budgets, timelines, and resource planning for clinical programs Mentor and guide junior staff within clinical operations Requirements Significant experience in clinical operations and project management Background working in pharmaceutical or biotechnology organizations Demonstrated ability to manage budgets and timelines Experience mentoring or managing team members

Flagship Pioneering, based in Cambridge, MA, builds and grows biotechnology platform companies. The organization brings together scientists, entrepreneurs, and investment to drive advances in areas like cancer diagnosis, disease treatment, and sustainable agriculture. Flagship’s portfolio has played a role in major public health and agricultural achievements and has earned recognition from FORTUNE and Fast Company for its impact and innovation. Role overview The Director of IT Service Delivery and Operations connects strategic IT goals with practical execution at Flagship Pioneering. This leader does not directly manage daily service delivery, but instead establishes the frameworks and governance that empower IT delivery teams. The position sets performance benchmarks, ensures transparency in operations, and oversees the rollout of new IT initiatives. Managing the transition of projects into ongoing operations, including structured hypercare support, is a key part of this role. Key collaboration and focus areas Partner with the Sr. Director of IT Service Delivery to define the service roadmap and set priorities Drive ITIL 4 service management maturity throughout the organization Promote operational discipline to help scale IT services for Flagship and its portfolio companies

Iterative Health is a pioneering healthcare technology and services firm dedicated to accelerating clinical research and enhancing patient outcomes. Our extensive Iterative Health Site Network comprises over 70 leading clinical research sites across the United States and Europe, fast-tracking the introduction of innovative gastrointestinal (GI) and hepatology therapies. We are committed to propelling the success and expansion of our partner sites by equipping them with cutting-edge tech-enabled services. By merging deep clinical trial expertise with state-of-the-art AI, we empower research teams and study sponsors to broaden and speed up access to novel therapeutics for patients in need.About the RoleWe are in search of a highly driven Finance Analyst to join our dynamic team. In this pivotal role, you will collaborate closely with Finance, Accounting, and operational teams, alongside cross-functional stakeholders, to enhance strategic decision-making and optimize financial operations across the organization. This is a high-impact position where you will gain invaluable hands-on experience supporting the financial functions of a rapidly growing healthcare technology company. You will also play a significant role in advancing our financial systems and infrastructure, particularly as we expand our joint venture (JV) partnerships and prepare for scale.ResponsibilitiesDevelop and maintain comprehensive financial models to assess revenue performance, key business metrics, and strategic growth initiatives.Prepare and deliver monthly reports to key business stakeholders, providing clear insights and transparency into financial performance.Support the automation and accuracy of reports as the company builds out an Enterprise Data Warehouse (EDW) and implements Adaptive Insights.Provide strategic analysis and actionable recommendations to facilitate decision-making across the organization.Enhance forecast accuracy by developing a deep understanding of financial and operational drivers.Fortify financial infrastructure and reporting processes to promote scalability, efficiency, and precision.Encourage strong collaboration between finance and business partners; work closely with operational teams to establish department-level KPIs and identify performance improvement opportunities.Contribute to high-impact financial initiatives, including board materials, investor communications, and other core finance functions.

Role overview Lila Sciences is hiring a Director of Laboratory Operations & Maintenance Management based in Cambridge, MA. This leadership position oversees daily laboratory activities and maintenance routines. The director sets operational strategies to ensure lab functions run efficiently and meet rigorous quality standards. A key focus of this role is to improve processes and refine protocols for optimal performance. Key responsibilities Develop and manage operational plans for laboratory workflows and maintenance schedules Implement practices that enhance efficiency and quality throughout lab operations Lead and support a team dedicated to laboratory success Monitor and refine maintenance protocols to reduce downtime Team environment Join a group of professionals who prioritize reliable laboratory results. The team emphasizes collaboration, continuous improvement, and close attention to detail in every aspect of lab operations.

Join Bluerock Therapeutics as a Senior Director - Clinical Operations Program Leader (COPL) in Ophthalmology. In this pivotal role, you will lead and optimize clinical operations for our ophthalmology programs, ensuring the successful execution of clinical trials and the advancement of innovative therapies.Your responsibilities will include strategic planning, cross-functional leadership, and oversight of clinical study execution, while collaborating closely with internal and external stakeholders.

The Lab Operations Analyst plays a critical role in optimizing laboratory processes and ensuring efficiency within our operations. This position involves analyzing workflows, identifying areas for improvement, and implementing solutions to enhance productivity and quality. You will collaborate with cross-functional teams to develop strategies that drive operational excellence in lab environments.

Cambridge Mobile Telematics (CMT) develops technology aimed at making roads safer. The DriveWell® Fusion platform processes data from millions of IoT devices, smartphones, connected cars, and dashcams using AI. Insurers, automakers, and mobility companies use these insights to better understand driver behavior and support safety efforts worldwide. Role overview The Analytics Engineer Intern works closely with both the IoT and Data Engineering teams. The main responsibilities include building data pipelines, developing reliable data models, and creating analytics tools that help teams make informed decisions. AI tools play a key role in the workflow, enabling faster pipeline development and improving data accessibility for stakeholders. This internship supports CMT’s IoT Operations and Product Analytics groups. Projects may include monitoring device performance or analyzing large-scale driver behavior trends. What we look for Strong motivation and technical skills Interest in AI and its practical applications Desire to contribute to safer roads through data-driven work Location Cambridge, MA

We are seeking a talented and driven Clinical Data and Analytics Lead to join our dynamic team in Cambridge, MA. This role will be pivotal in overseeing the collection, management, and analysis of clinical data to ensure the highest quality of insights and analytics. You will collaborate with cross-functional teams to develop data solutions that drive strategic decisions and improve patient outcomes.The ideal candidate will have a strong background in clinical data management, proven analytical skills, and a passion for leveraging data to enhance healthcare delivery. If you are ready to make a significant impact in the field of clinical analytics, we want to hear from you!