Director, Country Operations Management AstraZeneca PlcDirector, Country Operations ManagementBoston, MA$162,566.40–$243,849.60 / yearEnsuring cross-functional collaboration of team and PMCOs through proactive communication with global study team members (Global Study Directors, Global Study Associate Directors, Global Study Managers), and other local study team members (Study Start-up Managers, Site Contract Associate Directors, Site Alliance Lead, Site Solutions Manager, CRAs, and ADCOM) to raise and resolve study specific blockers quickly. The DCOM is a key contributor in the overall deliverables for the country, including early planning, feasibility, site selection, study start-up, enrollment, data deliverables, and close-out, and works in partnership with global study team, SDHCO, Dir SSU and Site Partnership, and RHCO to define those deliverables.
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.
Senior Manager / Site Director, Clinical Operations Adams ClinicalSenior Manager / Site Director, Clinical OperationsWatertown, MassachusettsThe 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.
Team Lead, Operations Technology Systems Analytics Tufts UniversityTeam Lead, Operations Technology Systems AnalyticsMedford, MASuccessful TTS staff are known for effectively applied expertise, continuous learning, thoughtful attention to detail, timely and appropriately calibrated follow-up, proactive and constructive problem solving, openness to new approaches, and for building effective partnerships and trust within TTS, across the university, and (where relevant) with external partners. All TTS staff are expected to follow departmental shared administrative practices, including effective planning and communication around time off, attending required TTS and university trainings, and developing professional goals as part of the PDP planning process.
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.
Senior Lab Operations Associate Manifold Bio IncSenior Lab Operations AssociateBoston, MA$85,000–$108,000 / yearReporting to the Associate Director of Operations, you will serve as a critical operational partner to our scientific teams by coordinating laboratory support activities, managing vendors and service providers, maintaining operational systems and records, and ensuring that routine laboratory operations run efficiently and reliably. Manifold Bio is a platform biotechnology company pioneering AI-guided protein design and massively multiplexed in vivo screening to unlock tissue-targeted medicines and organism-scale models of living systems.
Clinical Strategy and Operations Lead (MBA Grad 2027) SolaceClinical Strategy and Operations Lead (MBA Grad 2027)Boston, MassachusettsReporting directly to the Chief Medical Officer’s Chief of Staff you'll serve as a strategic partner across the organization, leading high-impact, cross-functional initiatives that enhance clinical quality, accelerate growth, and expand our service offerings. Exceptional analytical, project management, and business development skills, with proven ability to break down complex problems, develop compelling business cases, and analyze operational data to drive decision-making.
Clinical Trials Project Manager CareerscapeClinical Trials Project ManagerBoston, MA$95,000–$125,000 / yearContractorOur client, a biopharmaceutical company based in Boston, is seeking a Clinical Trials Project Manager to oversee the execution of Phase II and Phase III clinical studies. This is a hybrid contract role based in Boston, with on-site presence required for study team meetings, site initiation visits, and sponsor audits.
Senior Manager, Clinical Program Quality and Excellence (Oncology) 3316 Takeda Development Center AmericasSenior Manager, Clinical Program Quality and Excellence (Oncology)MassachusettsFacilitate investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities. Provides quality assurance oversight of the global clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU) and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
Senior Clinical Director, Clinical Research, Hematology Merck & Co IncSenior Clinical Director, Clinical Research, HematologyBoston, MA$282,200–$444,200 / yearThe Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies.
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.
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 Lead Early Clinical and Experimental Therapeutics SanofiClinical Lead Early Clinical and Experimental TherapeuticsCambridge, MA$206,250–$343,750 / yearKey Internal/External Relationships: Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups. This position located within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS) / Early Clinical and Experimental Therapeutics (ECET) is responsible for ECET contributions across all therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, gene therapy including nucleic acid modalities.
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).
Associate Director, Clinical Operations Kymera TherapeuticsAssociate Director, Clinical OperationsWatertown, MA$160,000–$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. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
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.
Senior Clinical Trial Manager Rapport Therapeutics IncSenior Clinical Trial ManagerBoston, MA$165,000–$185,000 / yearSupport the development, review and tracking of study-related documents (protocols, ICFs, investigative brochure, monitoring visit reports, etc.) with cross functional team collaboration. Maintain and organize trial documentation (e.g., TMF/eTMF oversight, trackers, meeting minutes) ensuring that study documentation is in a continuous state of inspection readiness.
Medical Director Clinical Development- Respiratory GSK plcMedical Director Clinical Development- RespiratoryWaltham, MA$222,750–$371,250 / yearIn addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
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.
Associate Director, Clinical Program Quality and Excellence (Oncology) 3316 Takeda Development Center AmericasAssociate Director, Clinical Program Quality and Excellence (Oncology)MassachusettsProvides quality assurance oversight of the global clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU) and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness. Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.