- Genentech (Boston, MA)
- …drive the programming and analytical strategy across one or more clinical studies , ensuring alignment with clinical and regulatory objectives, accountable to the TA ... documentation, and proactively addressing potential risks to support internal audits and global health authority inspections + You drive and uphold data and… more
- Sanofi Group (Cambridge, MA)
- …IIIB & IV clinical trials, observational and prospective real-world evidence studies . You'll have opportunities to develop innovative statistical solutions to ... success and have a meaningful impact on patients' lives. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve… more
- Bristol Myers Squibb (Cambridge, MA)
- …+ Assists in the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other ... toxicity studies as required. + Act as a Nonclinical Safety...parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All… more
- Pfizer (Cambridge, MA)
- **POSITION SUMMARY** You will lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of ... signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. You will work in close collaboration...Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …strategy, library sciences, and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel ... the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the… more
- Sanofi Group (Cambridge, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the ... of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a...15189), CLIA accreditation, lab developed test, and clinical performance studies .Ability to synthesize and critically analyze data from multiple… more
- Takeda Pharmaceuticals (Boston, MA)
- …people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in ... everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a… more
- Sanofi Group (Waltham, MA)
- …under the supervision of the head of Preclinical or Non-Clinical Team and/or the TED Global head who are all part of the Global Biostatistical Sciences (GBS) ... for methodological and statistical aspects of pre-clinical and/or non-clinical studies , with general direction from Research Project Leader or technicians.… more
- Sanofi Group (Cambridge, MA)
- …will work closely with his/her respective Medical Program Lead (MPL) and TA Global Medical Team (GMT), both internally and with our collaborative Alliance partner ... to ensure alignment of key activities outlined in the Global Medical Plans. We are an innovative global...RWE, study data milestones, and budget specific to all studies defined in the Medical plan + Compliance reporting… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …is an important role within the Medical Excellence & Operations team within Global Medical Affairs. This role is responsible for end-to-end management of contracts ... that support Global Medical Affairs operations, excluding those with healthcare professionals...scientific communications) + CRO/ vendor contracts for medical affairs-sponsored studies (eg, observational, RWE, Phase IV) + Data sharing,… more