Regional Director of Clinical Research Sites

Iterative Health is a pioneering healthcare technology and services company dedicated to revolutionizing clinical research and enhancing patient outcomes. With an extensive network of over 70 clinical research sites in the U.S. and Europe, we are at the forefront of accelerating the market introduction of innovative gastrointestinal (GI) and hepatology therapies. Our mission is to empower our partner sites through advanced tech-enabled services, leveraging our deep expertise in clinical trials and state-of-the-art AI to broaden access to groundbreaking therapeutics for patients in need.About the RoleThe Regional Director will lead and enhance the performance of GI-focused clinical research sites within their portfolio. This role is crucial in ensuring operational excellence, aligning teams to achieve key performance metrics, elevating site capabilities, and maintaining consistency in trial execution. As a strategic leader in operations, the Regional Director will bridge site performance with overarching business objectives.ResponsibilitiesOversee staff across multiple sites, ensuring alignment with protocols, regulatory standards, and Iterative Health's guidelines.Take full ownership of site performance, encompassing recruitment, data integrity, compliance, and team culture.Ensure sites are optimally prepared for success through adequate staffing, equipment, and training, providing recommendations for resource allocation based on business needs.Foster strong partnerships with Principal Investigators (PIs) to align their engagement with study objectives and operational strategies.Influence the study portfolio to enhance profitability and patient value.Proactively identify and address issues related to site performance.Guide and develop Clinical Research Coordinators (CRCs) and site-based research personnel through clear expectations, performance coaching, and team development.Act as a visible and hands-on leader, cultivating high-performing, accountable teams.Analyze KPIs and monitor performance trends to identify and leverage factors driving site-level success.Implement corrective actions and process enhancements as necessary.Serve as the primary operational liaison between site personnel and central functions.Promote a culture of accountability, collaboration, and continuous improvement throughout all assigned sites.

Scholar Rock is a pioneering biopharmaceutical company dedicated to the discovery, development, and delivery of transformative therapies for patients suffering from serious diseases with significant unmet medical needs. As a global frontrunner in the understanding of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is aptly named for the visual resemblance of a scholar rock to protein structures. The company is currently in the clinical stage, focusing on advancing groundbreaking treatments that leverage protein growth factors to create better health outcomes. Over the past decade, Scholar Rock has cultivated a robust pipeline aimed at improving the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, cancer, and other areas where growth factor-targeted therapies could effectuate significant change. Scholar Rock stands out as the sole company to demonstrate clinical proof of concept for a muscle-targeted treatment for spinal muscular atrophy (SMA). We are committed to pioneering fundamentally different therapeutic approaches, supported by our proprietary platform that has developed novel monoclonal antibodies capable of exquisitely modulating protein growth factors. By utilizing cutting-edge scientific advancements in disease areas that have been historically underserved by conventional therapies, Scholar Rock is dedicated to unlocking new possibilities for patients. To learn more about our innovative approach, visit ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:The Medical Director/Senior Director will report directly to the Senior Vice President of Clinical Research and will play a crucial role within the late-stage development team. This individual will be responsible for overseeing the clinical development activities for product candidates, guiding them from Proof-of-Concept through to marketing approval and ongoing lifecycle management. The ideal candidate will provide medical leadership for the clinical development of apitegromab and other late-stage product candidates in accordance with the overall corporate strategy. This role requires an enthusiastic physician-scientist with substantial hands-on experience in advancing late-stage product candidates to deliver revolutionary therapies.

As a Clinical Site Relationship Manager, you will play a pivotal role in fostering strong partnerships with clinical sites, ensuring seamless operations and enhancing the overall clinical trial experience. Your expertise will be vital in managing site relationships, providing support, and facilitating communication between stakeholders to achieve successful trial outcomes.

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases with significant unmet needs. Where others perceive obstacles, we recognize opportunities that we pursue with a sense of urgency, scientific rigor, and steadfast dedication to the communities we serve. Our focus is currently on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on the commitment of our team. Our core values—be audacious, be curious, be authentic, be engaged, and be accountable—foster a culture of care. At Amylyx, we have assembled a highly skilled team eager to take decisive action because the communities we support cannot afford to wait. If you share our enthusiasm and are committed to addressing some of the most challenging problems in medicine, we invite you to explore the opportunity below and submit your application.The OpportunityThe Director of Clinical Sciences will play a pivotal role within the Clinical Development team, providing essential scientific guidance for ongoing projects. This position reports to a Medical Director and involves cross-functional collaboration with R&D, program management, clinical operations, biostatistics, and data management. The candidate will support and propel key developmental efforts for clinical studies and the execution of the overall Clinical Development Plans (CDP).

At Iterative Health, we are at the forefront of healthcare technology and services, dedicated to revolutionizing clinical research and enhancing patient outcomes. Our Site Network is a distinguished consortium of over 70 clinical research sites across the United States and Europe, accelerating the introduction of innovative therapies in gastrointestinal (GI) and hepatology. We focus on empowering our partner sites with technology-driven services, combining extensive clinical trial expertise with cutting-edge artificial intelligence (AI), enabling research teams and sponsors to broaden and hasten access to essential therapeutics for patients.We are pioneering the integration of advanced, proprietary AI tools in cardiology and drug development, aiming to significantly enhance clinical decision-making while improving patient lives through superior diagnosis, disease management, and treatment.As a Senior Clinical Research Specialist I, you will report to the Head of Cardiology and Growth, collaborating closely with the Director of Clinical Research (Cardiology) to integrate Iterative Health’s services and AI solutions at cardiology-focused clinical research sites nationwide. This role requires exceptional communication skills, customer engagement, and comprehensive clinical research expertise, coupled with a robust strategic skill set. You will directly support a portfolio of sites by assessing their current state using our established methodologies, delivering tailored training and ongoing assistance to promote research best practices, drive the adoption of Iterative Health’s services, and ensure that our sites meet their research objectives.

Scholar Rock is a pioneering biopharmaceutical enterprise dedicated to the discovery, development, and delivery of transformative therapies for individuals with serious diseases that are significantly underserved. Renowned for its leadership in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is committed to advancing innovative treatments where protein growth factors are essential. Over the last decade, the company has established a robust pipeline aimed at enhancing the standard of care for various conditions including neuromuscular diseases, cardiometabolic disorders, and cancer, where growth factor-targeted therapies can make a monumental difference. Scholar Rock stands out as the only organization to demonstrate clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our dedication to exploring fundamentally novel therapeutic strategies is driven by the application of a proprietary platform that has yielded innovative monoclonal antibodies designed to modulate protein growth factors with remarkable selectivity. By leveraging advanced scientific approaches in historically neglected disease areas, Scholar Rock is committed to unlocking new opportunities for patients. Discover more about our mission at ScholarRock.com and connect with us on @ScholarRock and LinkedIn.Position Overview:The Medical Director, reporting to the VP of Clinical Research, will play a vital role in the early development team, responsible for steering clinical development initiatives for product candidates from IND to Proof-of-Concept. This role demands a highly driven physician scientist with hands-on experience in advancing product candidates aimed at delivering impactful medicines. The successful candidate will provide medical leadership for clinical development activities related to follow-on indications for apitegromab and new product candidates, aligning with corporate strategy.

About eGenesiseGenesis is an innovative clinical-stage biotechnology company dedicated to developing human-compatible engineered organs to tackle the critical global organ shortage. Our proprietary genome engineering platform facilitates extensive, multiplex gene edits aimed at removing major biological barriers, incorporating protective human transgenes, and inactivating endogenous retroviruses. Our flagship program, EGEN-2784, a genetically engineered porcine kidney, is currently undergoing evaluation in a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). Headquartered in the vibrant city of Cambridge, MA, eGenesis is at the forefront of pioneering medical solutions.As the Lead Clinical Research Associate, you will spearhead site monitoring activities and oversee Clinical Research Associates (CRAs) for designated clinical trials. Collaborating closely with Clinical Operations leadership and cross-functional teams, you will ensure that studies are executed in strict adherence to protocols, ICH-GCP guidelines, regulatory requirements, and our company Standard Operating Procedures (SOPs).

Iterative Health is at the forefront of healthcare technology and services, dedicated to expediting clinical research to enhance patient outcomes. With a robust Site Network comprising over 70 clinical research sites across the United States and Europe, we specialize in accelerating the journey to market for innovative therapies in gastrointestinal (GI) and hepatology. Our mission is to foster the growth and success of our partner sites by equipping them with advanced technology-driven services. By merging extensive clinical trial expertise with pioneering AI solutions, we empower research teams and study sponsors to broaden and hasten access to crucial novel therapeutics for patients in need.About the RoleWe are on the lookout for a proactive and detail-oriented Clinical Research Finance Specialist to become a vital member of our expanding Finance team. This role entails close collaboration with the Finance Manager to oversee comprehensive accounts receivable operations related to sponsor-funded clinical studies and internal research sites.As a key player, you will manage essential transactional accounts receivable workflows, including monitoring sponsor and site-level accounts, facilitating timely collections, posting cash in RealTime CTMS, and providing invoicing support as necessary. This position demands strong collaboration with internal teams, research sites, and sponsors and CROs to guarantee precise billing, timely cash application, and swift resolution of outstanding balances.The ideal candidate will thrive in a dynamic clinical research environment, adeptly balancing hands-on execution with cross-functional teamwork and a commitment to continuous process enhancement.Key ResponsibilitiesManage daily accounts receivable operations, including monitoring sponsor and site-level balances and aiding in timely collections.Reconcile study-level balances and payment activities, identifying discrepancies and collaborating with stakeholders to resolve issues.Accurately record cash receipts and payment details in RealTime CTMS and related financial systems.Prepare and dispatch invoices for study activities and services in coordination with sponsor communications and internal teams.Professionally communicate with sponsors and CROs regarding billing inquiries, payment statuses, and outstanding balances.Assist in generating AR aging schedules, financial summaries, and internal reports.Support audits and financial reviews pertaining to accounts receivable and billing activity.Work collaboratively with Clinical Operations, Site Finance, and Accounting to clarify billing terms and deliverables.Contribute to ongoing process improvements to boost accounts receivable efficiency, accuracy, and visibility.

At Iterative Health, we are at the forefront of healthcare technology, revolutionizing clinical research to enhance patient outcomes. Our Site Network comprises over 70 top-tier clinical research sites across the US and Europe, focusing on advancing gastrointestinal (GI) and hepatology therapies. We empower our partner sites with innovative, technology-driven services, combining extensive clinical trial expertise with advanced AI solutions. Our mission is to facilitate swift access to groundbreaking therapeutics for patients in need, thereby improving lives and health outcomes.The Clinical Data Specialist plays a pivotal role in our clinical trial service operations, primarily responsible for conducting electronic health record (EHR) reviews to identify eligible patients for clinical trials.

Iterative Health is seeking a Clinical Research Systems Specialist to help advance clinical research operations by supporting and maintaining system solutions. This position plays a key role in ensuring that clinical research management systems run smoothly and meet the needs of various teams across the organization. What you will do Work with cross-functional teams to address clinical research system requirements Implement new clinical research management systems and handle ongoing maintenance Support data integrity and compliance throughout all research activities Location This role is based in either Cambridge, Massachusetts or New York, New York.

Imagine a scenario where you could be a part of a pioneering organization that not only creates but also nurtures life sciences companies dedicated to pioneering transformative technologies in healthcare and sustainability.Montai Therapeutics is a forward-thinking, privately held biotechnology firm that leverages artificial intelligence to unlock the potential of diverse chemistry, aiming to develop innovative oral medicines that effectively address longstanding unmet needs in chronic diseases. Through our cutting-edge CONECTA™ platform, we have established the world's premier foundation models that decode the intricate relationship between nature's bioactive chemistry and human biology, thus revolutionizing the drug discovery process with unmatched versatility and predictability.We have meticulously curated a collection of over 1 billion Anthromolecules™ and Anthrologs™, derived from compounds that humans have historically consumed through food, supplements, and herbal remedies. This extensive database has provided us with efficient access to a vast array of chemical diversity, enabling us to selectively and precisely influence complex biological systems. Montai is rapidly progressing a pipeline of groundbreaking oral medications targeting validated biological pathways in inflammation and immunology, with a focus on developing biologic replacements for traditionally challenging transcription factors.Position Overview:We are actively seeking a seasoned Head of Clinical Development to report directly to our Chief Executive Officer. This individual will hold primary responsibility for the strategic development and implementation of clinical programs for small molecules within the therapeutic realms of immunology and inflammation at Montai Therapeutics. We invite applications from highly motivated, collaborative, and results-driven professionals who possess the adaptability, creativity, and resourcefulness necessary to thrive in our dynamic environment.The Head of Clinical Development will be instrumental in steering the seamless transition of programs from research to clinical phases, as well as shaping comprehensive clinical strategies that encompass everything from candidate discovery to human proof-of-concept trials. As a pivotal leader in our clinical development efforts, this role involves the formulation and integration of clinical development plans that align with our research, translational, nonclinical, regulatory, and strategic goals. Additionally, this individual will oversee the teams responsible for supporting program operations, resource allocation, and interactions with both internal governance and external partners. This role is ideal for an experienced professional who is passionate about transforming innovative scientific discoveries into groundbreaking therapies through meticulous and collaborative planning and execution.

Harvard University is seeking an innovative and strategic Associate Director of Research to lead groundbreaking research initiatives. The ideal candidate will possess a deep understanding of research methodologies, strong leadership skills, and a passion for academic excellence. This role involves collaborating with faculty and students to enhance research output and drive impactful scholarship.

We are seeking a highly skilled and experienced Director of Clinical Quality to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will be responsible for overseeing the clinical quality management systems, ensuring compliance with regulatory standards, and driving continuous improvement in clinical processes.Your leadership will be vital in fostering a culture of quality and safety, collaborating with multidisciplinary teams to enhance patient outcomes and operational efficiency.

Company Overview Fulcrum Therapeutics is an innovative clinical-stage biopharmaceutical organization dedicated to enhancing the quality of life for patients suffering from genetically defined rare diseases that exhibit a significant unmet medical need. Our proprietary product engine is adept at identifying drug targets capable of modulating gene expression to address the underlying causes of gene misexpression. We are currently advancing our flagship asset, FTX-6058 (pociredir), a small molecule engineered to elevate fetal hemoglobin expression for the treatment of sickle cell disease and beta thalassemia. Position Summary The Associate Director of Clinical Science will collaborate closely with the Executive Medical Director and VP of Clinical Development to provide critical support across one or more Clinical Project Teams at Fulcrum Therapeutics. This role is pivotal in ensuring the effective design and execution of Clinical Development Plans, focusing on crafting cost-efficient clinical trials that fulfill the needs of both internal and external stakeholders. The successful candidate will assume responsibility for the scientific oversight of clinical studies, working in partnership with study program leadership and cross-functional team members. This includes the interpretation and communication of clinical trial data, which are crucial for high-quality regulatory submissions. Key responsibilities encompass contributing to the design and execution of company-sponsored clinical trials at all developmental phases, analyzing clinical trial data, and facilitating internal and external communications regarding project plans and progress. The Associate Director will also be involved in safety monitoring and mitigation strategies, as well as making significant contributions to regulatory submissions, publications, and communications of clinical data.

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

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 eGenesis as a Senior Clinical Research AssociateAt eGenesis, we are at the forefront of innovation in biotechnology, developing human-compatible engineered organs to combat the critical global organ shortage. Our cutting-edge genome engineering platform allows for extensive gene modifications, effectively removing biological barriers and introducing protective human transgenes. Our leading program, EGEN-2784, involves a genetically engineered porcine kidney currently under a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). We are proudly headquartered in Cambridge, MA, and are dedicated to making a significant impact on healthcare.We are currently in search of a highly skilled Senior Clinical Research Associate with over 4 years of experience in monitoring intricate clinical trials within pharmaceutical, biotechnology, and CRO settings. The ideal candidate will demonstrate proven expertise in managing investigative sites, conducting site qualifications, initiation, routine monitoring (both on-site and remote), and closeout visits while ensuring adherence to ICH-GCP, regulatory requirements, and study protocols. You will be tasked with overseeing site performance, preserving data integrity through source data verification and CRF review, and maintaining timely documentation in eTMF, CTMS, and EDC systems. Additionally, you will support site start-up activities, provide training for investigators and site staff, and offer operational guidance to academic medical centers, particularly those with limited IND experience. The right candidate will possess strong capabilities in identifying operational risks, implementing effective mitigation strategies, and managing high volumes of clinical data to uphold patient safety, data quality, and study compliance. Reporting to the Lead CRA or Clinical Operations leadership, you will execute monitoring strategies and facilitate consistent oversight of assigned sites. We value collaboration and are looking for a team player who can work closely with investigative sites and cross-functional teams to enhance enrollment, address operational challenges, and ensure inspection readiness.

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.

At Iterative Health, we are at the forefront of healthcare technology, dedicated to revolutionizing clinical research and improving patient outcomes. With a robust network of over 70 clinical research sites across the US and Europe, we expedite the journey to market for innovative gastrointestinal (GI) and hepatology therapies. Our mission is to empower our partner sites with advanced, tech-enabled services, merging extensive clinical trial expertise with state-of-the-art AI solutions, allowing research teams and study sponsors to broaden and hasten access to groundbreaking therapeutics.As a pioneering organization in applying powerful proprietary AI tools within gastroenterology, cardiology, and drug development, we aim to significantly enhance clinical decision-making, thereby improving patient lives through superior diagnostics, disease management, and treatment approaches that lead to better health outcomes.The Clinical Data Specialist plays a crucial role in our clinical trial service operations by conducting EHR chart reviews to identify suitable candidates for clinical trials.

Join our dynamic team as a Clinical Trial Leader, where you will be at the forefront of innovative clinical research. You will be responsible for overseeing the planning, execution, and management of clinical trials, ensuring compliance with all regulatory requirements and organizational standards. Your leadership will guide cross-functional teams to deliver high-quality results, contributing to the advancement of healthcare solutions.