- Takeda Pharmaceuticals (Cambridge, MA)
- …of clinical pharmacology studies. + Extensive experience in late-state drug development , regulatory submissions and life-cycle management. + Hands-on ... the QCP function in interactions with global or regional regulatory agencies at significant development milestones such...+ Strong knowledge of allied fields critical for drug development , such as statistics, outcome research , Real… more
- Sanofi Group (Cambridge, MA)
- …diverse array of biological modalities, and work collaboratively with multidisciplinary Research and Development teams to characterize safety liabilities, advise ... communication skills. **Terms of employment** + Occasional domestic travel to Sanofi Research and Development sites, CRO sites, and scientific meetings.… more
- ICON Clinical Research (Boston, MA)
- …statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager. + Development of ... awareness of internal and external developments (scientific, clinical, competitive, and regulatory ) that could impact the development plan, including attendance… more
- Astellas Pharma (Cambridge, MA)
- …in program management efficiently and effectively to improve productivity of drug discovery research & development in Oncology Research . The PMEL is ... academic research with dee[ understanding of Drug Discovery and Development process. + Demonstrated effective cross-functional leadership in drug discovery … more
- Sanofi Group (Cambridge, MA)
- …Biostatistics.** You will be leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical ... to improve people's lives.** Combining deep immunoscience expertise with cutting-edge research and development , we drive transformative breakthroughs that… more
- Sanofi Group (Cambridge, MA)
- …reach of our R&D pipeline by identifying new disease indications for therapies in research and development and by helping shape future areas of immunoscience for ... assessments to identify novel disease indications for therapies in early- and mid-stage research and development , grounded in immune pathway relevance and unmet… more
- Merck (Boston, MA)
- …discovery and development (MIDD) to routinely enable efficient drug discovery/ development and/or regulatory decisions. The Pharmacometrics group within QP2 ... with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents. **Associate Directors… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's ... Biology, Physics, Statistics, or a related technical discipline + PhD >1 year of relevant research experience...is an E-Verify employer. This position requires permanent work authorization in the United States. Research and Development… more
- ThermoFisher Scientific (Boston, MA)
- …to achieve individual career goals while taking science a step beyond through research , development and delivery of life-changing therapies. With clinical trials ... conducted in 100+ countries and ongoing development of novel frameworks for clinical research ...and completeness of information presented in analytical documents and regulatory filings. Assist with comment resolution if needed +… more
- Chiesi (Boston, MA)
- …into impactful narratives for global stakeholders. + Partner with R&D, clinical development , regulatory , and commercial teams to ensure seamless, consistent ... About us Based in Parma, Italy, Chiesi is an international research -focused pharmaceuticals and healthcare group with 90 years' experience, operating in 30 countries… more