Senior Director, US Head Country Operations Management, Study Start-up & Site Partnership AstraZeneca PlcSenior Director, US Head Country Operations Management, Study Start-up & Site PartnershipBoston, MA$211,655–$317,482 / yearIntroduction to Role: The Senior Director, US Head of Country Operations, Study Start-up & Site Partnerships will lead the US operating model and end-to-end delivery of clinical studies-from early indication planning and feasibility through site selection, start-up, enrollment, data delivery, and close-out. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
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.
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.
Manager or Senior Manager, Clinical Outsourcing Kymera TherapeuticsManager or Senior Manager, Clinical OutsourcingBoston, MA$115,000–$215,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. 5+ years' experience within clinical outsourcing or a closely related clinical operations role (Manager level); 8+ years for consideration at the Senior Manager level.
Senior Manager or Associate Director, Translational Medicine Operations Kymera TherapeuticsSenior Manager or Associate Director, Translational Medicine OperationsWatertown, MA$145,000–$240,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Partner cross-functionally with Translational Medicine, Clinical Operations, Biomarker Scientists, CROs, CRUs, and external vendors to ensure successful execution of biomarker and biospecimen activities.
Medical Director-Oncology Clinical Development - GI GSK plcMedical Director-Oncology Clinical Development - GIWaltham, MA$222,750–$371,250 / yearAnalytical Thinking, Clinical Data Interpretation, Clinical Development, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.
Clinical Lead Early Clinical and Experimental Therapeutics Oncology SanofiClinical Lead Early Clinical and Experimental Therapeutics OncologyCambridge, MA$206,250–$343,750 / yearIn these roles, duties include: Design safe, rapid and informative First-In-Human studies for oncology assets potentially including natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic studies. A key focus of this role is to support the path from the research phase through early clinical development including early and rapid Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute to Human Target Validation (HTV) and evaluating the pharmacology of novel therapeutic approaches.
Clinical Research Director SanofiClinical Research DirectorCambridge, MA$206,250–$343,750 / yearParticipates and contributes to regulatory and safety documents and discussions: Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Clinical Research & Development Associate Director Myositis/Immunology AstraZeneca PlcClinical Research & Development Associate Director Myositis/ImmunologyCambridge, MA$142,171.20–$213,256.80 / yearStudy level: Serving as the clinical science resource for assigned studies (and in some instances as the Study Clinical Lead); supporting/leading development of Clinical Study Protocols (CSPs), informed consent forms (ICFs), and electronic data capture (EDC) database specifications in line with the approved CDP and target product profile; supporting ongoing clinical data review and interpretation at study and program level with input from the study/program physician; contributing to development of quality metrics and data review plans for assigned studies; support and contribute to medical monitoring of trials; supporting the compilation and interpretation of data for dose‑escalation/safety review committees; supporting protocol amendments and other strategic documents; and supporting review of the Clinical Study Report. ESCR and external engagement: Co‑leading/supporting ESCR strategy and implementation for the program; serving as the interface between the GPT and external clinical research; supporting investigator/site relationships for site selection and study start‑up; co‑leading/supporting clinical proposal reviews, protocol reviews and scientific oversight for academic basket/umbrella and ESCR studies; identifying and managing ESCR portfolio risks and escalating quality issues through appropriate channels; supporting representation of the project internally and externally with key experts and partners and contributing to alliance development.
US MDM And Supply Chain Operations Specialist SanofiUS MDM And Supply Chain Operations SpecialistWaltham, MA$71,250–$102,916.66 / yearReporting to the Business Excellence Manager, the incumbent applies functional expertise in SAP S/4HANA and Supply Chain management to execute daily Master Data operations, ensure data integrity, and support continuous improvement initiatives across the "R&D to GMP" lifecycle. Experience: Minimum 4 years of relevant experience in Supply Chain operations, preferably within Pharmaceutical, Biotech, Healthcare, Life Sciences, or other industries, with a focus on SAP Master Data Management and digital tools implementation.
Clinical Operations Associate I (College Grad 2027) SolaceClinical Operations Associate I (College Grad 2027)Boston, MassachusettsSolace cuts through the red tape of healthcare by pairing patients with expert advocates and giving them the tools to make better decisions—and get better outcomes. Clinical or healthcare interest is a significant plus—it'll help you understand context faster and build better systems, but we care more about operational chops than clinical credentials.
Head of Clinical AI Portfolio, Senior Director, AI for Clinical Development AstraZeneca PlcHead of Clinical AI Portfolio, Senior Director, AI for Clinical DevelopmentCambridge, MAYou will also develop and own the operating model that connects the function's work to clinical impact: how clinical questions become well-posed, prioritized problems for our research and applied AI teams, and how research capabilities reach clinical and study teams and change decisions. Success depends on being exceptional connectors: you'll actively leverage existing capabilities, celebrate and promote reuse, export breakthrough ideas across geographies and functions, and obsess over scaling impact rather than building in isolation.
Clinical Trial Manager/ Sr. Clinical Trial Manager City TherapeuticsClinical Trial Manager/ Sr. Clinical Trial ManagerCambridge, Massachusetts$164,000–$185,000 / yearYou will partner closely with internal stakeholders, CROs, Investigators/clinical sites and external vendors to deliver Phase 1 dose-escalation through later-phase global clinical trials on time and within budget,, ensuring quality and compliance with ICH-GCP and regulatory requirements. Foster strong partnerships with investigators, site staff, external partners and internal stakeholders to support efficient study execution and achievement of enrollment and delivery targets.
Senior Clinical Studies Associate DeephealthSenior Clinical Studies AssociateSomerville, Massachusetts$71,000–$96,000 / yearFull timeWorking under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking.
Senior Manager, Clinical Data Management Amylyx PharmaceuticalsSenior Manager, Clinical Data ManagementCambridge, MARemote$156,000–$175,000 / yearThis individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans – identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF).
Senior Manager, Clinical Data Management Amylyx Pharmaceuticals IncSenior Manager, Clinical Data ManagementCambridge, MARemote$156,000–$175,000 / yearThis individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans - identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF).
NewStrategic Clinical Quality Manager Fresenius Medical CareStrategic Clinical Quality ManagerWaltham, Massachusetts$79,000–$133,000 / yearin-center, home hemodialysis and home peritoneal dialysis), and in collaboration with the IDT, is responsible for the monitoring data/information; prioritizing areas for improvement; determining potential root causes; developing, implementing, evaluating, and revising plans that result in improvements in clinical quality outcomes in dialysis facilities within a geography. Applies current knowledge of FMS clinical and administrative policies and procedures, available internal resources, working knowledge of CMS Conditions of Coverage for ESRD facilities, Value Based Payer Programs, knowledge of quality improvement concepts, principles and practices to perform tasks and duties.
Sr. Director, Head of Clinical Quality Assurance Scholar RockSr. Director, Head of Clinical Quality AssuranceCambridge, MAThe position is accountable for clinical quality strategy, GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose processes that embed quality by design across the clinical trial lifecycle. Summary of Position: Scholar Rock is seeking an experienced and motivated Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for Good Clinical Practice (GCP) quality across the company’s biologics clinical development portfolio.
NewManager, Clinical Study Operations Beacon Biosignals IncManager, Clinical Study OperationsBoston, MA$115,000–$135,000 / yearManage Beacon''s day-to-day working relationship with sponsors - and, where applicable, a CRO intermediary - on the studies your direct reports run, and step in to represent Beacon directly with the sponsor when a study lead escalates a decision that needs strategic alignment or sign-off. You are expected to bring hands-on clinical trial operations experience - enough to guide your direct reports through site and vendor issues, coach sound day-to-day tradeoffs, and step in directly on complex or high-stakes situations when needed.
Clinical Research, Senior Principal Scientist (Director), Oncology Lantheus Holdings IncClinical Research, Senior Principal Scientist (Director), OncologyBedford, MA$172,000–$287,000 / yearProvide scientific leadership to cross-functional teams spanning Clinical Operations, Imaging Sciences and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, Pharmacovigilance, CMC, Translational Sciences and external partners. The role shapes clinical research strategy and leads the scientific design, execution, interpretation and communication of company-sponsored clinical research, with particular emphasis on diagnostic imaging, radiopharmaceuticals and molecular imaging.