Manager, Regional Regulatory Lead - LCM CSLManager, Regional Regulatory Lead - LCMWaltham, MA$129,000–$153,000 / yearDeveloping regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products. Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.
Operations Support Specialist Beacon Hill Staffing GroupOperations Support SpecialistBoston, Massachusetts$30–$35 / hourFull timeLearn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com . Our client, a life sciences services company, is seeking an Operations Support Specialist to provide onsite administrative and operational support within a large, well-established research environment in Boston.
Sr./Clinical Trial Manager - Clinical Operations Aktis Oncology IncSr./Clinical Trial Manager - Clinical OperationsBoston, MAAktis' most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.
Clinical Trial Manager, Clinical Operations, Infectious Disease Moderna IncClinical Trial Manager, Clinical Operations, Infectious DiseaseCambridge, MA$109,200–$174,600 / yearWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
Senior Manager / Site Director, Clinical Operations Adams ClinicalSenior Manager / Site Director, Clinical OperationsWatertown, MA$120,000–$150,000 / yearThe Senior Manager provides site-level leadership and operational ownership of clinical operations, with direct responsibility for staff management, study execution, regulatory compliance, strategic alignment with network leadership, and ensuring high-quality trial execution that meets sponsor expectations and business objectives. The Site Director assumes the same core clinical operations responsibilities while providing broader site-wide leadership through additional support of the Clinical Science function, clinician development, cross-functional performance, and integration of clinical science with site operations in partnership with Clinical Science leadership.
Senior Manager, Clinical Operations - GI Iterative HealthSenior Manager, Clinical Operations - GICambridge, MA$140,000–$165,000 / yearAs the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health's mission of bringing innovative therapies to patients faster.
Senior Manager, Clinical Operations - GI Iterative Scopes Inc.Senior Manager, Clinical Operations - GICambridge, MAAs the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health's mission of bringing innovative therapies to patients faster.
Senior Manager, Clinical Operations - GI Iterative Scopes IncSenior Manager, Clinical Operations - GICambridge, MA$140,000–$165,000 / yearAs the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health''s mission of bringing innovative therapies to patients faster.
Director/Sr. Director, Clinical Operations - Oncology Programs Frontier MedicinesDirector/Sr. Director, Clinical Operations - Oncology ProgramsBoston, MA$185,000–$250,000 / yearFrontier Medicines is seeking two experienced Clinical Operations leaders, at the Director or Senior Director level, to drive the operational strategy and execution of our oncology programs as they advance through clinical development. The ideal candidate brings deep oncology experience, strong global study oversight, and the ability to influence stakeholders, anticipate challenges, and deliver results in a dynamic biotech environment.
Clinical Study Operations Manager Beacon Biosignals IncClinical Study Operations ManagerBoston, MARemote$90,000–$110,000 / yearAs such, we''re always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon's clinical studies, from startup through close-out.
Director, Clinical Research Operations WhoopDirector, Clinical Research OperationsBoston, MassachusettsLead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
NewDirector, Early Oncology Clinical Operations Technology & Vendor Excellence AstraZeneca PlcDirector, Early Oncology Clinical Operations Technology & Vendor ExcellenceCambridge, MA$171,622–$257,433 / yearSitting at the intersection of clinical operations, digital innovation, and strategic vendor management, this role shapes how CPSO and its COE enabling communities harness technology - from Central Lab Partnerships (CLP), Outsourced CRO Partnerships, Interactive Response Technology (IRT) systems to digital health tools and Artificial Intelligence (AI)-enabled process automation. Provide strategic oversight of our Outsourcing Partnership Model, CLP Model, key platform areas including IRT/RTSM, digital health tools, Vendor AI and automation capabilities, and emerging technologies relevant to clinical trial delivery.
Clinical Operations Manager Tessera TherapeuticsClinical Operations ManagerSomerville, MA$164,000–$199,000 / yearYou have previously demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Bachelor's degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.
Associate Director, Clinical Operations – Therapeutics/Oncology ModernaTXAssociate Director, Clinical Operations – Therapeutics/OncologyCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives.
Executive Director Clinical Operations, Program Management (Cell Therapy) AstraZeneca PlcExecutive Director Clinical Operations, Program Management (Cell Therapy)Cambridge, MA$270,188.80–$405,283.20 / yearAccountabilities: Franchise Leadership: Clinical Operations Strategy: Define and implement short- and long-term clinical operations strategies across franchises, including therapeutic operating models, country footprint and site strategies, and consistent, deliverable operational clinical development plans. Cross-Functional Integration: Build deep partnerships with shared functions (Data Management, Vendor Management, Lab Management groups, Logistics, Manufacturing) to co-create and execute fit-for-purpose cell therapy strategies.
Associate Director, Clinical Research Operations Dana-Farber Cancer Institute IncAssociate Director, Clinical Research OperationsBOSTON, MA$129,500–$150,200 / yearProficiency with clinical research and healthcare technology systems, including electronic medical record systems (such as EPIC), clinical trial management systems (specifically OnCore), electronic protocol and regulatory compliance tracking systems (such as iRIS), electronic data capture platforms (like RedCap), financial and HR systems (WorkDay), and advanced Microsoft Office and data analysis tools, with meticulous attention to detail and the ability to manage multiple high-priority initiatives simultaneously. As a senior leader, the Associate Director builds and develops high-performing teams, fosters a culture of collaboration, accountability, innovation, and continuous improvement, and serves as the department's primary representative for clinical research initiatives within the institution and across external research networks.
NewClinical Study Operations Manager Beacon BiosignalsClinical Study Operations ManagerBoston, MassachusettsRemoteAs such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon’s clinical studies, from startup through close-out.
Associate Director, Clinical Operations Compliance Scholar Rock Holding CorpAssociate Director, Clinical Operations ComplianceCambridge, MA$175,000–$225,000 / yearServe as the Clinical Operations compliance subject matter expert for SOPs, GCP, ICH, FDA, EMA, and other applicable regulatory requirements, ensuring practical application/compliance across study teams and vendors throughput the trial lifecycle. Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases.
Associate Director/Director, Clinical Operations Compliance Scholar RockAssociate Director/Director, Clinical Operations ComplianceCambridge, MAServe as the Clinical Operations compliance subject matter expert for SOPs, GCP, ICH, FDA, EMA, and other applicable regulatory requirements, ensuring practical application/compliance across study teams and vendors throughput the trial lifecycle. Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases.
Clinical Operations Manager Tessera Therapeutics IncClinical Operations ManagerSomerville, MA$164,000–$199,000 / yearYou have previously demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Bachelor's degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials.