Research Associate Co-Op, Bioanalytical Keros TherapeuticsResearch Associate Co-Op, BioanalyticalLexington, MA$28–$32 / hourWith a focus on developing differentiated product candidates that are designed to alter TGF- signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.
Clinical Development Associate Medical Director- gMG Vertex PharmaceuticalsClinical Development Associate Medical Director- gMGBoston, Massachusetts$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Clinical Development Associate Medical Director- Pain Vertex PharmaceuticalsClinical Development Associate Medical Director- PainBoston, Massachusetts$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Clinical Development Associate Medical Director-Nephrology Vertex Pharmaceuticals, IncClinical Development Associate Medical Director-NephrologyBoston, MA$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Clinical Development Associate Medical Director- Gmg Vertex Pharmaceuticals, IncClinical Development Associate Medical Director- GmgBoston, MA$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
NewSenior Manager, Clinical Scientist Replimune Group, Inc.Senior Manager, Clinical ScientistWoburn, MA$159,000–$205,500 / yearThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Director Clinical Scientist, ensures the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners.
Manager Clinical Data Monte Rosa Therapeutics IncManager Clinical DataBoston, MAThis individual will work closely with Clinical Operations, Biostats and Programming, Medical, Safety, Regulatory, external CROs, and technology vendors to ensure high-quality, inspection-ready clinical data. Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers.
Senior Nonclinical Writer (US) MMSSenior Nonclinical Writer (US)Boston, MARemoteStrong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, 1st Edition Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs). With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.
Clinical Scientist, Neuroimmunology & Specialty Care, PDT 3316 Takeda Development Center AmericasClinical 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 Medical Director, Oncology Clinical Development - Sarcoma GSK plcSenior Medical Director, Oncology Clinical Development - SarcomaWaltham, MA$284,250–$473,750 / yearClinical Data Interpretation, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations, Strategic Direction. Operating within the clinical strategy defined by the Clinical Development Lead (CDL), the Senior Medical Director partners closely with the Senior Scientist and cross-functional teams to guide the integration of physician expertise into study execution and programme-level decision-making.
Research Physiologist Goldbelt, Inc.Research PhysiologistNatick, Massachusetts$94,000–$114,000 / yearFull timeProficient in exercise and metabolic measurements including maximal oxygen uptake, submaximal exercise testing, resting ventilation, and pulmonary function testing. The Research Physiologist will provide technical assistance on the collection of human physiological data in environmental extremes of heat, cold, high terrestrial altitude, and subterranean.
Clinical Pharmacist - Medical Oncology Lahey Hospital and Medical CenterClinical Pharmacist - Medical OncologyCambridge, MA$120,640–$162,364.80 / yearThe Clinical Pharmacist is responsible for the optimization of drug therapy by identifying, resolving, and preventing drug related problems and improving therapeutic outcomes through their work in drug distribution, centralized pharmacy operations, and/or in patient care rounds. This pharmacist will work in a mainly decentralized role, including providing clinical coverage for medical oncology patients, potential cross coverage of medical/surgical patients, and teaching opportunities within our Pharmacy Residency Program.
Senior Director -Project Toxicologist - Clinical Pharmacology and Safety Sciences (Boston or Gaithersburg) AstraZeneca PlcSenior Director -Project Toxicologist - Clinical Pharmacology and Safety Sciences (Boston or Gaithersburg)Boston, MA$227,602–$341,404 / yearExtensive experience working as a Project Toxicologist across different therapy areas within the pharmaceutical/biotech project environment delivering pre-clinical toxicology packages and successful marketing for a range of modalities which should include small molecules, peptides and oligonucleotides. We value kindness alongside ambition, giving you the trust, tools, and cross-functional partnerships to lead with confidence and shape studies that matter-so your decisions today translate into meaningful patient impact tomorrow.
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.
Sr. Clinical Trial Manager Frontier Medicines CorpSr. Clinical Trial ManagerBoston, MADirector, Clinical Operations, you will serve as a key operational contact for our CROs and trial sites, helping drive feasibility assessments, site selection, start-up, maintenance, and close-out. This is a hybrid role based in our Boston, MA office, with an expectation of 2-3 days per week onsite, plus periodic travel to trial sites and CRO/vendor meetings as needed.
Manager/Senior Manager, Clinical Data Management Beam Therapeutics IncManager/Senior Manager, Clinical Data ManagementCambridge, MA$130,000–$190,000 / yearBeam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. Reporting to the Senior Director of Data Management, this role is responsible for driving study-level data management activities from study start-up through database lock while ensuring high-quality, inspection-ready clinical data.
Director, Clinical Pharmacology Modelling and Simulation (CPMS) Oncology GSK plcDirector, Clinical Pharmacology Modelling and Simulation (CPMS) OncologyWaltham, MA$188,100–$313,500 / yearWe are seeking professionals with the following required skills and qualifications to help us achieve our goals: PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modeling/simulation to solve practical problems in industry or academia. 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.
Senior Programmer, Clinical Data Evaluation CSL Behring LLCSenior Programmer, Clinical Data EvaluationWaltham, MA$143,000–$169,000 / yearWe use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Senior Manager, Clinical Data Enablement 3316 Takeda Development Center AmericasSenior Manager, Clinical Data EnablementMassachusettsThis role builds scalable ingestion and transformation capabilities, partners closely with internal stakeholders and external vendors, and ensures reliable, compliant delivery of clinical data products to downstream consumers. The Senior Manager, Clinical Data Enablement is responsible for operating and continuously improving end-to-end clinical data pipelines across cloud-based data lake and data warehouse environments.
Senior Clinical Trial Manager, Cambridge, MA Isomorphic Labs LimitedSenior Clinical Trial Manager, Cambridge, MACambridge, MASupport data management activities such as reviewing study-related materials created by data management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan. By harnessing AI's powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world's most devastating diseases.