Medical Science Liaison – Neurodegeneration (United States) PrileniaMedical Science Liaison – Neurodegeneration (United States)Boston, MassachusettsRemoteAbout Prilenia Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Medical Science Liaison (MSL) in the United States, to support programs in both Huntington’s Disease and ALS. The MSL will serve as a scientific expert in HD and ALS while building collaborative partnerships with neurologists, thought leaders and multidisciplinary care teams to support Prilenia’s clinical trials and programs.
Senior Director, Epidemiology and Real World Evidence Dyne TherapeuticsSenior Director, Epidemiology and Real World EvidenceWaltham, MA$245,000–$300,000 / yearThe Senior Director partners closely with Global Medical Directors, HEOR, Clinical Development, Biometrics, Drug Safety/Pharmacovigilance, Regulatory Affairs, Value & Access, and Commercial to generate and interpret evidence that enables asset‑level Medical Affairs strategies. Leads the design, execution, and interpretation of epidemiologic and observational studies supporting Medical Affairs objectives, including chart reviews, post hoc analyses, prospective observational studies, investigator-initiated studies, Phase 3b/4 studies, and prevalence/incidence studies.
Associate Director/ Senior Clinical Trial Manager Thorough GroupAssociate Director/ Senior Clinical Trial ManagerBoston, MassachusettsAs the organization continues to advance its pipeline, they are seeking an experienced and highly motivated Associate Director or Senior C linical Trial Manager (CTM) to provide operational leadership for ongoing and upcoming clinical studies. This individual will play a critical role in study start-up, site activation, enrollment strategy, risk management, and overall trial execution while collaborating closely with cross-functional stakeholders across the organization.
Medical Writer (Remote, US) Getinge ABMedical Writer (Remote, US)Boston, MARemoteStrong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, relevant MDCG guidance, ISO 14155, ICH guidance including E3 CSR, E6 (R3) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO14971). Performs comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required.
Senior Manager, Accounting- Clinical Accruals Monte Rosa Therapeutics IncSenior Manager, Accounting- Clinical AccrualsBoston, MAResponsibilities • Own the end-to-end clinical trial accrual process, including monthly and quarterly close activities • Review and analyze CRO and vendor reports (e.g., investigator grants, pass-through costs, milestone payments) • Develop and maintain accrual models for multiple clinical programs across phases • Ensure compliance with U.S. GAAP related to R&D accruals • Partner with Clinical Operations to understand trial status, enrollment metrics, site activations, and study timelines • Coordinate directly with CROs to validate cost-to-complete estimates and resolve discrepancies • Responsible for all accounting operations including general ledger, accounts payable, and payroll as well as managing a small team of direct reports • Review and approve weekly payment runs • Prepare/release bi-weekly payroll and serve as a resource for related compliance matters • Help maintain consolidation for all entities and manage related matters with outsourced providers domestically as well as for foreign subsidiary based in Switzerland • Partner with the Controller in developing policies and interpretation of GAAP guidance for key accounting and reporting areas as needed • Contribute to development, implementation and documentation new accounting policies and procedures to scale within the organization • Help establish, monitor, and enforce internal policies, procedures, and controls • Support and coordinate preparation for financial statement audits and tax compliance reporting • Assist with the annual preparation of 1099s • Assist with FP&A to develop and maintain framework for reporting and analysis. Experience developing internal controls and driving implementation of policies and procedures Experience with review and preparation of financial statements; corporate, payroll and sales tax filings and requirements Experience with general ledger functions and the month-end/year end close process in a setting requiring consolidations, multiple subsidiaries, including international.
Clinical Project Manager Relay Therapeutics IncClinical Project ManagerCambridge, MA$102,000–$145,000 / yearDevelop and maintain strong working relationships with internal and external stakeholders (cross-functional team members, Contract Research Organizations (CROs), external experts, and clinical site staff), ensuring high-quality services are executed in a timely and cost-effective manner. Experience managing global clinical trials and study teams across all stages (startup-closeout) of phase I-III studies and a strong working knowledge of GCP/ICH and other applicable regulations/guidelines required.
Clinical Project Associate Relay Therapeutics IncClinical Project AssociateCambridge, MA$61,000–$87,000 / yearYour Role: Partner with Clinical Project Managers to support the day-to-day operations of clinical trial execution, with a focus on site start-up, study participant enrollment, clinical monitoring, GCP and protocol compliance, from the clinical sites, CROs and vendors. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology.
Post Market Surveillance Specialist Hologic IncPost Market Surveillance SpecialistMarlborough, MAThe incumbent may be required to perform additional duties related to the functions listed below, as reasonably necessary to meet business needs, including but not limited to: Developing professional expertise, applies company policies and procedures to resolve a variety of issues, including fulfillment, assay and instrument complaints. Driven by our purpose to enable healthier lives everywhere, every day, we are seeking a talented and experienced Electrical Engineer to join a growing R&D department in our Surgical Division to contribute to new.
Associate Director, Clinical Operations Clinical Dynamix, Inc.Associate Director, Clinical OperationsWatertown, MAWork 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. Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
Project Manager, Clinical Research - New Site Build Iterative Scopes IncProject Manager, Clinical Research - New Site BuildBoston, MA$80,000–$110,000 / yearThis role is ideal for an experienced project manager who enjoys building new programs, thrives in highly cross-functional environments, and is passionate about expanding patient access to innovative cardiovascular clinical trials. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Global Medical Lead, PDT Hematology (f/m/x) Takeda Pharmaceutical Co LtdGlobal Medical Lead, PDT Hematology (f/m/x)Cambridge, MA$192,400–$302,390 / yearLead the development and implementation of the division's short and long-term business strategies (scientific communication strategy, evidence generation strategy, capability building strategy and KOL engagement plan) to optimize markets for future and current products and development of rational strategic plans for profiling and indication expansion of licensed products. Supports clinical research strategy and lead complimentary evidence generation strategy, including but not limited to Phase IV clinical trials for licensed products and gives input on new product development for successful launch into the marketplace.
Associate Director, Medical Writer MannKind CorpAssociate Director, Medical WriterBedford, MARemoteMannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. Oversee the development and finalization of high-quality, scientifically accurate, ICH-compliant documents, including clinical study protocols and reports, Investigator Brochures, Periodic Safety Updates, patient narratives, and manuscripts for peer-reviewed publications.
Pioneering Medicines: Associate Director / Director, Clinical Operations Flagship Pioneering IncPioneering Medicines: Associate Director / Director, Clinical OperationsCambridge, MA$148,000–$236,500 / yearPioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship''s scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Flagship has been recognized twice on FORTUNE's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company's annual list of the World's Most Innovative Companies.
VP - Academic Partnerships (Remote, East Coast preferred, USA) Evotec SEVP - Academic Partnerships (Remote, East Coast preferred, USA)Boston, MARemote$171,700–$232,300 / yearPartner with internal scientific and drug discovery teams to shape development plans to de-risk early concepts and enable the translation from idea into a therapeutic concept to be tested in humans. Collaborate cross-functionally with internal teams including research, business development, and alliance management to ensure successful program execution.
Senior Director, Head of Medical Review Takeda Pharmaceutical Co LtdSenior Director, Head of Medical ReviewBoston, MA$212,000–$333,190 / yearThe actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. Responsible for leading and conducting process impact assessments in response to changes in regulatory requirements identified through Takeda's regulatory intelligence activities, and for implementing the appropriate changes to ensure compliance with the new regulatory requirements.
Clinical Scientific Director Takeda Pharmaceutical Co LtdClinical Scientific DirectorCambridge, MA$177,000–$278,080 / yearEducation, Experience, Knowledge and Skills: Education and experience: Advanced life science degree or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Data Science or Clinical Operations, and Drug Discovery Unit and other preclinical functions based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds.
Environmental Health and Safety Specialist Charles River Laboratories International IncEnvironmental Health and Safety SpecialistShrewsbury, MA$86,000–$97,000 / yearFrom individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com.
Senior Veterinary Pathologist Charles River Laboratories International IncSenior Veterinary PathologistWilmington, MA$220,000–$230,000 / yearWhile performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), and/or work near live animals with risk of exposure to allergens and/or zoonotic diseases. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.
Director, Clinical Pharmacology Takeda Pharmaceutical Co LtdDirector, Clinical PharmacologyCambridge, MA$177,000–$278,080 / yearThe actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. Takeda believes there is tremendous potential to do more to meet patients' and health care providers' expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases.
Associate Director, Scientific Communications Lead, Solid Tumors, Global Medical Affairs Oncology Takeda Pharmaceutical Co LtdAssociate Director, Scientific Communications Lead, Solid Tumors, Global Medical Affairs OncologyCambridge, MA$169,400–$266,200 / yearYou will develop and implement strategic publications and scientific communications plans in coordination with relevant cross-functional teams (including members of medical affairs, clinical development, and outcomes research; global, regional, or local); leads the publications planning team; manages the development of scientific publications for external audiences and scientific communications materials such as slide decks, NCCN or pathway submissions, animations, and digital amplification of data; manages vendors, freelancers, and available contractors, writers, and editors in the execution of publication and scientific communications tactics; and manages annual budget planning for each assigned program(s). This individual will work closely with the Scientific Communications Group Lead, Solid Tumors to optimize department resources and evaluate trends in medical publications, and lead and/or participate in the development and review of publications SOPs and Work Practices, where appropriate, to ensure delivery of high-quality medical publications in a timely and compliant manner across programs.