- Otsuka America Pharmaceutical Inc. (Boston, MA)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including sample collection, storage conditions, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …leadership at LOC level Decision-making and Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support ... development of state of the art HE models and studies (eg, SLRs, ITCs) with sufficient evidentiary support to...LOCs on product value platforms, new evidence and HE studies and models + Co-lead with Pricing & Market… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Medical School-affiliated hospitals. The Statistician in this role will have the title Associate Director of the Breast Oncology Statistical Program and is ... data analytic activities of more junior statisticians and/or leads complex projects. ** Study Design:** Trains, mentors and oversees the design activities of more… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and ... usability engineering processes + Support formative and summative human factors study training **Regulatory Engagement:** + Support audits from internal teams and… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Associate Director - Principal Medical Writer **Location:** USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable ... expertise in clinical development processes + Strong understanding of clinical study methodology and basic statistics + Knowledge of regulatory environment +… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... clinical deviations and Serious Breaches. + Review the clinical deviations across studies managed by Clinical Program Quality team and share insights to trends… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Participate in study concept, protocol and SAP development for Real World Studies and ensure appropriateness of study design, sample size and statistical ... statistical expertise for analysis of clinical trials data beyond the study endpoints, including secondary, exploratory, subgroup analyses. The overall purpose is… more
- Pfizer (Cambridge, MA)
- …input and leadership to cross-functional activities - collaborate with other statisticians, study managers, programmers - for assigned studies and regulatory ... successful candidate will collaborate closely with cross-functional project and study teams, offering statistical expertise in designing clinical trials, developing… more
- Pfizer (Cambridge, MA)
- …plans across projects and disease areas in order to optimize prospective studies , inform drug development strategy and project decision-making, in collaboration with ... characteristics, and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development. + Identifies opportunities where… more
Recent Jobs
-
Early Childhood Educational Fall Soccer Coach
- Super Soccer Stars Coaching (Ashburn, VA)