NewSenior Manager/Associate Director, Global Safety Scientist, MSRM Agios PharmaceuticalsSenior Manager/Associate Director, Global Safety Scientist, MSRMCambridge, MA$153,541–$230,312 / yearManager level is expected to be between $131,035 and $196,553 annualized and the current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Global Safety Scientist will work closely with the Head of Safety Sciences and the Global Safety Leads and be responsible for leading and planning the development of aggregate safety reports, signal detection review, authoring and analyzing data for safety topic reports, and creation and update of risk management plans.
Senior Group Director, Clinical Scientist AstraZeneca PlcSenior Group Director, Clinical ScientistWaltham, MA$221,500–$332,250 / yearRecognizing 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. You will also be assigned to a project and are leading a team of clinical scientists and will be an important part of the project Team, working collaboratively with the program and study level physician or clinical lead as their guide in medical scientific aspects of the compound and its development.
Sr. Clinical Scientist/Associate Director, Clinical Science Celldex Therapeutics IncSr. Clinical Scientist/Associate Director, Clinical ScienceMA$133,579–$199,501 / yearAuthor (and/or work with external medical writers to develop) clinical documents including but not limited to clinical protocols/amendments, briefing documents, IND annual reports, Investigators Brochures, clinical study reports, scientific presentations including abstracts, posters and manuscripts. Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborate with statisticians to produce statistical analysis plans and data displays; provide input to CRF design and data management processes; perform periodic review of clinical data).
Junior Clinical scientist SanofiJunior Clinical scientistCambridge, MA$122,250–$176,583.33 / yearMain responsibilities: Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, lay summary …). Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to GPV or safety events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
Clinical/Development - Senior Clinical Scientist TalentBurst, Inc.Clinical/Development - Senior Clinical ScientistCambridge, MARemoteClinical Scientist will ideally be familiar with drug development and regulatory requirements and will deploy this expertise in the execution of a number of key responsibilities: Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam. Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support.
Director, Clinical Scientist Aktis Oncology IncDirector, Clinical ScientistBoston, 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. Deliver quality study strategy and design, including analysis and interpretation of data throughout the study, including leading clinical data review with Data Management; develop and review clinical narratives; and monitor clinical data for specific trends.
Senior Clinical Scientist nference incSenior Clinical ScientistCambridge, MAWork with some of the brilliant minds of the world solving exciting real-world problems through Artificial Intelligence, Machine Learning, analytics, and insights through triangulating unstructured and structured information from the biomedical literature as well as from large-scale molecular and real-world datasets. Our team brings together computer scientists, biologists, and medical experts (MDs and PhDs) from top universities, creating a fast-paced and innovative environment to solve real-world biomedical challenges.
Senior Manager, Global Clinical Scientist - Psychiatry Bristol-Myers Squibb CoSenior Manager, Global Clinical Scientist - PsychiatryCambridge, MA$173,390–$210,110 / yearp>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. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
Associate Director, Clinical Scientist Zenas BioPharma (USA) LLCAssociate Director, Clinical ScientistWaltham, MA$161,700–$202,200 / yearThis position works closely with Medical Directors to support medical monitoring activities, while partnering cross-functionally with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Medical Affairs, and Regulatory Affairs to translate clinical strategy into operational deliverables and ensure rigorous ongoing review of trial data for quality, safety, and protocol compliance. Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody.
NewAssociate Director, Clinical Scientist Kiniksa PharmaceuticalsAssociate Director, Clinical ScientistLexington, MassachusettsThe successful candidate will act as a primary bridge between raw clinical data and clinical decision-making, working in close collaboration with the Chief Medical Officer, Clinical Development Lead, and cross-functional program team. Responsibilities (including, but not limited to): Active Data Surveillance: Conduct daily reviews of the clinical trial data to monitor specific data entries, including patient diary scores, and relevant laboratory markers.
Director, Clinical Scientist Kailera TherapeuticsDirector, Clinical ScientistWaltham, MassachusettsThis role partners closely with Clinical Operations and cross-functional teams to ensure high-quality trial conduct, rigorous data review, and clear scientific communication from study start-up through reporting. Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs.
Clinical Scientist, Neuroimmunology & Specialty Care, PDT TakedaClinical Scientist, Neuroimmunology & Specialty Care, PDTBoston, MassachusettsThis 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.
Senior Manager, Clinical Scientist, Respiratory Kymera Therapeutics IncSenior Manager, Clinical Scientist, RespiratoryWatertown, MA$145,000–$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. 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.
Director, Clinical Scientist Kelonia Therapeutics IncDirector, Clinical ScientistBoston, MA$190,000–$252,000 / yearAct 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.
NewSenior Clinical Scientist (Cambridge, MA) PhilipsSenior Clinical Scientist (Cambridge, MA)Cambridge, MAli>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.
Associate Director, Clinical Scientist EyePoint IncAssociate Director, Clinical ScientistCambridge, MA$154,500–$249,947 / yearLevel 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.
Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology Merck & Co IncClinical Director (Principal Scientist), Clinical Research, Immunology - RheumatologyBoston, MA$255,800–$402,700 / yearThe 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.
(Assoc.) Director, Clinical Development Scientist-Urologic Oncology Aura Biosciences Inc(Assoc.) Director, Clinical Development Scientist-Urologic OncologyMA$170,000–$245,000 / yearp>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.
Machine Learning Scientist – Clinical Prediction Iambic TherapeuticsMachine Learning Scientist – Clinical PredictionBoston, MassachusettsYou 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.
Clinical Director (Principal Scientist), Translational Medicine, Immunology Merck & Co IncClinical Director (Principal Scientist), Translational Medicine, ImmunologyBoston, MA$260,300–$409,700 / yearInterface 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.
Senior Field Clinical Scientist - Remote Abbott LaboratoriesSenior Field Clinical Scientist - RemoteBoston, MARemoteIf 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.
Principal Scientist, Cancer Immunology Clinical Translational Research Bristol-Myers Squibb CoPrincipal Scientist, Cancer Immunology Clinical Translational ResearchCambridge Crossing, MA$159,290–$193,022 / yearProactively 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.
Sr. Scientist Clinical Pharmacology Alnylam Pharmaceuticals IncSr. Scientist Clinical PharmacologyCambridge, MA$140,300–$189,700 / yearp>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.
Associate Director, Clinical Research Scientist (Neurology) Alkermes PlcAssociate Director, Clinical Research Scientist (Neurology)Waltham, MAIn 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.
NewMedical Laboratory Scientist I - Clinical Immunology Brigham and Women's HospitalMedical Laboratory Scientist I - Clinical ImmunologyBoston, MA$27.95–$40.70 / hourul>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.
Sr. Scientist/Principal Scientist, Translational Research and Clinical Biomarkers (Immunology) Antares TherapeuticsSr. Scientist/Principal Scientist, Translational Research and Clinical Biomarkers (Immunology)Boston, MassachusettsCollaborate 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.
Analytical Development Senior Research Scientist, Clinical Manufacturing Investigations Vertex Pharmaceuticals IncAnalytical Development Senior Research Scientist, Clinical Manufacturing InvestigationsBoston, MA$122,400–$183,600 / yearThis 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.
Staff Data Scientist, Clinical Performance Latitude Health IncStaff Data Scientist, Clinical PerformanceBoston, MA$160,000–$200,000 / yearp>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.
Sr. Principal Scientist, Clinical Operations Immunology Lead Merck & Co IncSr. Principal Scientist, Clinical Operations Immunology LeadBoston, MA$210,400–$331,100 / yearp>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.
Clinical Development Scientist Viridian Therapeutics IncClinical Development ScientistWaltham, MARemoteCollaborate 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.
Clinical Genomic Variant Scientist Variantyx IncClinical Genomic Variant ScientistFramingham, MAp>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.
Medical Laboratory Scientist I - Clinical Immunology Mass General BrighamMedical Laboratory Scientist I - Clinical ImmunologyBoston, MassachusettsAs 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 .
NewSenior Scientist II - Non-clinical Safety Novo Nordisk ASSenior Scientist II - Non-clinical SafetyLexington, MA$150,000–$190,000 / yearp>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.
Research Scientist, Clinical Outcome Assessment Thermo Fisher Scientific IncResearch Scientist, Clinical Outcome AssessmentWaltham, MA$150,000–$170,000 / yearThe 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.
Director, Clinical Development Scientist (Non-MD) Pfizer IncDirector, Clinical Development Scientist (Non-MD)Cambridge, MA$176,600–$294,300 / yearProvides 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.
Director - Clinical Research Scientist Eli Lilly and CoDirector - Clinical Research ScientistBoston, MA$193,500–$338,800 / yearOur 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.
Clinical Development Scientist (Senior Director) Pfizer IncClinical Development Scientist (Senior Director)Cambridge, MA$214,900–$358,100 / yearProvides 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.
Scientist I, Clinical Development Foundation Medicine IncScientist I, Clinical DevelopmentBoston, MA$113,000–$135,000 / yearThis 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.
Clinical/Development - Scientist TalentBurst, Inc.Clinical/Development - ScientistCambridge, MAstrong> 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.
Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control Disc Medicine IncPrincipal Scientist/Associate Director, Analytical Development & Clinical Quality ControlMA$158,000–$193,000 / yearThese 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.
Associate Director, Clinical Scientist CRISPR TherapeuticsAssociate Director, Clinical ScientistSouth Boston, MassachusettsThe 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.
Clinical/Development - Scientist, Analytical Development LanceSoft IncClinical/Development - Scientist, Analytical DevelopmentCambridge, MAFull timeThe 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.
Clinical Development Scientist, Director (Inflammation and Immunology) PfizerClinical Development Scientist, Director (Inflammation and Immunology)MassachusettsExperience applying AI, machine learning, or advanced analytics in clinical development or research (e.g., protocol design and optimization, site selection and feasibility assessment, query management and workflow automation, data cleaning, anomaly detection, and signal identification, safety risk prediction and proactive mitigation). Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Oncology Clinical Development Scientist, Director Pfizer IncOncology Clinical Development Scientist, DirectorMA$176,600–$294,300 / yearli>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.
Oncology Clinical Development Scientists (Senior Manager) Pfizer IncOncology Clinical Development Scientists (Senior Manager)MA$139,100–$231,900 / yearli>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.
Oncology Clinical Development Scientist (Director) Pfizer IncOncology Clinical Development Scientist (Director)Cambridge, MA$176,600–$294,300 / yearFollow 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.
Distinguished Scientist, Clinical Research, Thoracic Malignancies Merck & Co IncDistinguished Scientist, Clinical Research, Thoracic MalignanciesBoston, MA$310,900–$489,400 / yearWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs, and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. Must have experience in industry in the field of Thoracic Oncology Minimum of 3 years of clinical medicine experience Minimum of 5 years of industry experience in drug development Demonstrated record of scientific scholarship and achievement A proven track record in clinical medicine and background in biomedical research is essential Strong interpersonal skills, as well as the ability to function in a team environment, are essential.
Clinical Imaging Scientist, Translational Radiology AstraZeneca PlcClinical Imaging Scientist, Translational RadiologyWaltham, MA$203,709.60–$305,564.40 / yearli>Experience functioning as the Imaging subject matter expert working with clinical development teams (evidence of leading cross functional teams focusing on good communication, passion for customers and working collaboratively). Understanding of the Blinded Independent Centralized Review process at external imaging CROs, including common review paradigms, radiologist reviewer analysis application and eCRFs, and operational and regulatory documents including Independent Review Imaging Charters.
Senior Scientist-Clinical Bioanalysis Kiniksa PharmaceuticalsSenior Scientist-Clinical BioanalysisLexington, MassachusettsThis individual will be a key part of the team driving for successful clinical implementation of bioanalysis strategy in partnership with internal research, clinical development and operations and external clinical laboratories to support success of Kiniksa clinical development programs of innovative therapies for immune‑mediated diseases. Partner with clinical development, operations to provide SME support to central lab activities aligned with current regulatory guidance and industry best practices while remaining fit‑for‑purpose for each phase of development, including but not limited to activities such as: Sample collection and handling strategies.
AVP, Head of Infectious Disease & Vaccines Clinical Science Merck & Co IncAVP, Head of Infectious Disease & Vaccines Clinical ScienceMA$342,800–$539,600 / yearThe Associate Vice President (AVP) ensures that Clinical Scientists deliver consistent, high quality‑ scientific and technical oversight of studies and assets, partnering closely with Clinical Directors (CDs), Product Development Team Leaders, Therapeutic Area Heads, Global Clinical Trials operations teams as well as other cross functional partners to advance programs from First-In-Human‑through registration and lifecycle management. Required Skills: Biostatistics, Client Management, Clinical Judgment, Clinical Research Methods, Conflict Resolution, Detail-Oriented, Innovation, Multiple Therapeutic Areas, Negotiation, New Technology Integration, People Leadership, Pharmacovigilance, Protocol Development, Strategic Planning, Visionary Leadership.