div>We are seeking a highly analytical and inquisitive Clinical Scientist to provide analytical support for a high-priority, Global Phase 2/3 pivotal program reporting to the Chief Medical Officer (CMO).
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Boston, Massachusetts30+ days ago
This role will work within the Neuroimmunology and Specialty Care team to support development of clinical assets across the United States, the European Union, and Japan, including protocol concept and protocol development, study start-up and execution, data cleaning, preparation of clinical study reports, and contributions to regulatory filings. Proven experience preparing clinical study protocols, Clinical Study Reports, integrated clinical statistical reports, and clinical sections for regulatory submissions across multiple regions, including Investigational New Drug and New Drug Application documentation.
Watertown, MA30+ days ago
Having 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 within a matrix environment, collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, data management, biostatistics, and other departments to drive clinical development programs forward.
Act as a primary contributor and owner of key clinical deliverables, including: Clinical study protocols and protocol amendments, Investigator's Brochures, Clinical study reports and data summaries, and Regulatory submission documents (e.g., INDs, amendments, briefing materials). As a Clinical Scientist in the Clinical Development group, you will support day-to-day medical monitoring, clinical development, data services, and pharmacovigilance for lead programs, as well as future indications.
Cambridge, MA30+ days ago
Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level EyePoint is committed to fair and equitable compensation practices. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required.
The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies. Job Description: The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Immunology therapeutic area.
li>Partner with cross-functional teams including R&D, Product Management, Systems Engineering, Regulatory Affairs, Quality, and Usability to ensure clinical workflow requirements, procedural considerations, and physician feedback are incorporated into product design and validation activities. Lead and support clinical collaborations with Key Opinion Leaders, research institutions, and healthcare partners, helping to design and execute studies, including usability, phantom, animal, clinical and other evidence-generation activities.
p>Position Summary: Aura Biosciences, Inc. is currently expanding its Clinical Development team to support several early- and late-phase clinical assets and is searching for a highly motivated and hands-on Associate Director/Director level Clinical Development Scientist to support the continued development of AU-011 in the treatment of ocular and urologic cancers. Knowledge of and experience applying the principles of clinical research methodology, statistics, data analysis and interpretation Proficiency in data review tools for data interpretation to both design/execute clinical trials and to extract data/prepare results for relevant clinical trials.
Boston, Massachusetts8 days ago
You will identify, curate, and evaluate datasets that support prediction of relevant clinical endpoints (patient- and trial-level outcome modeling, safety/toxicity prediction, and PK/PD response modeling) and fine-tune Enchant to deliver critical clinical insights. This includes developing rigorous, leakage-resistant experimental frameworks, optimizing training, orchestrating runs at scale, and working with colleagues across ML and clinical functions to put these models into the hands of scientists making real therapeutic decisions.
Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world. • Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation and executing clinical studies to evaluate the relevance of potential targets to human disease in order to justify investment in clinical development programs.
If you provide content to customers through CloudFront you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFrontRequest ID E6m2XNTdIW5eWKlDRBuJm0SI8DciyHRt8XTlIFkRV7gj4g2M6hzDpQ.
Cambridge Crossing, MA30+ days ago
Proactively provides insight into novel ways to incorporate biomarkers into clinical designs to enable early understanding of emerging drug profiles, as well as input around tumor types and potential impact of biomarkers on internal decision making. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Cambridge, MA30+ days ago
p>Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.
In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
p>In a competitive external landscape and fast-paced internal environment, the Immunology Clinical Operations Lead position provides both strategic and operational leadership across early immunology programs, ensuring timely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide. Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients.
li>Collaborate with teams across the organization, including clinical operations and data management, to ensure biomarker assay implementation and execution, and aid in the management of biomarker samples and data. The actual salary offered will be based on a number of factors, including but not limited to the qualifications of the applicant, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location in which the applicant lives and/or from which they will be performing the job..
p>While your primary focus is evaluative, you will be a key player in the broader clinical DS ecosystem, collaborating on patient risk stratification and building the forecasting engines that predict our quality performance across various value-based care programs. Automate Model Lifecycles with AI Agents: Architect and oversee AI-driven agents that autonomously manage the end-to-end lifecycle of our statistical models - leveraging automation for continuous training, deployment, performance monitoring, and proactive model refreshes.
ul>As outlined by CLIA, after successful completion of orientation, training and competency assessment on all instruments/methods applicable to their role: Follow the laboratory''s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical consultant, technical supervisor, clinical consultant or director; and.
Marlborough, MA8 days ago
p>Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.
Boston, Massachusetts8 days ago
As outlined by CLIA, after successful completion of orientation, training and competency assessment on all instruments/methods applicable to their role: -Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. -Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical consultant, technical supervisor, clinical consultant or director; and .
Framingham, MA30+ days ago
p>About Variantyx: Variantyx is an award-winning, technology-driven molecular diagnostics lab that offers innovative solutions in the genetic disorders, reproductive health, and precision oncology markets.
Responsibilities:
Your duties will include interpreting sequence variants in the context of genetic disorders, curating medical and molecular literature, and compiling clinical draft reports.
This role is critical in ensuring the success of clinical manufacturing processes for our cell therapy programs by leading technical investigations, resolving quality events, and driving continuous improvement in analytical development. Cross-Functional Communication and CAPA Implementation: Serve as a liaison between manufacturing, quality control, quality assurance, and analytical development teams to address and resolve quality events.
Cambridge, MA30+ days ago
Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Organization Overview:
Verve, a wholly owned subsidiary of Eli Lilly, is seeking a Senior Director - Clinical Research Scientist (CRS) to help lead clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease.
Cambridge, MA30+ days ago
Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
This role executes on strategic scientific collaborations involving a range of functions and external collaborators, supporting studies that establish the clinical validity and utility of products and biomarkers aligned to Clinical Development Plans and FMI enterprise strategy. Working with Clinical Development leadership, this position will execute analysis for and support studies through conceptualization, narrative building, and writing using clinical cohorts or real-world evidence in partnership with the project lead.
li>Collaborate closely with Clinical Operations colleagues on clinical trial activities and timelines, including Informed consent development and review, data management activities and review of data management plans and other documents, and management of clinical development document deliverables to meet the operational needs of the program. Support Clinical Development in the activities associated with execution of clinical trials and data collection, including training of the internal team, vendors, and site staff; preparation of case report forms; identification and prevention of protocol deviations; and resolution of issues.
The Research Scientist will lead the response to client requests and serve as Principal Investigator (PI) for Clinical Outcome Assessment (COA) strategy and research, including qualitative and quantitative studies to support instrument development, content validity, psychometric validation, and application. Lead the development of study designs, budgets, and proposals as Principal Investigator, with full accountability for scientific and operational delivery, encompassing mixed-methods research integrating qualitative and quantitative (psychometric) approaches.
p>Lead multiple projects as subject matter expert, function as project leader for projects comprising multiple experimental activities & coordination of activities to meet deadlines, communicate project updates & experimental results, provide expert-level guidance to experimental plans & data interpretation; may propose & lead external research efforts to support project goals; attend & present at scientific conferences as an NN-subject matter expert; deep understanding of subject matter & demonstrate creative thinking & solutions for addressing critical scientific questions; may supervise junior staff; author internal reports & external publications; recommend, present, & champion new targets or methodologies. Internal relationships include working closely with technical staff & other members of the scientific leadership team; regular collaborations with members of other research departments at Novo Nordisk; & frequent interaction with project managers & other colleagues across global R&D.
Cambridge, MA30+ days ago
strong> Qualifications- PhD in Chemistry, Biochemistry or related disciplines with 1-4 years industry experience, Master's degree with > 6 years related industry experience or Bachelor's degree with > 10 years related industry experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise. Key Responsibilities
- Develop, qualify, and troubleshoot chromatographic (GC, HPLC/UPLC) and LCMS based methods for the identification, characterization, and impurity profiling of oligonucleotides, siRNAs, and their formulations, as well as raw material related analytical methods and other methods as needed.
These techniques include but are not limited: chromatographic techniques (CEX, SEC, HILIC, etc.), mass spectrometry-based techniques including peptide mapping (LC/MS) and intact mass, capillary electrophoresis, differential scanning calorimetry (DSC) or fluorimetry (DSF), glycosylation content measurement, ELISA, and potency assays. POSITION OVERVIEW: Reporting to a Director of Analytical Development/Clinical QC, this position requires expert knowledge of the biopharmaceutical drug development process in late-stage development, with working knowledge and experience in method development, transfer of analytical methods, and management of external vendors.
South Boston, Massachusetts30+ days ago
The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Westborough, MA27 days ago
p>This role collaborates closely with the leadership of Clinical Affairs to execute clinical research strategy activities and oversee aspects of clinical trials in support of clinical evidence generation strategies across the GIS - Gastrointestinal Solutions Division; GI (including core GI, EUS, and Infection Prevention), EndoTherapy, Medical Service, and Endoscopic Solutions Ecosystem. Specifically, this individual will be responsible for writing clinical study protocols, case report forms, and study reports; will work closely with study sites to obtain necessary approvals (EC/IRB); and will respond critically to questions raised throughout the clinical study execution.
Cambridge, MA30+ days ago
The Scientist, is part of Analytical Development Starting Material Group and will be responsible for Develop, qualify and transfer GC, HPLC, UPLC and mass spectrometry based assays of starting materials, raw materials, intermediates and excipients to suppliers, CMOs and QC. Author and review method development and qualification reports and SOPs for test methods, as well as transfer / qualification protocols and reports related to critical starting materials / intermediates / excipients.
li>Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.