- Takeda Pharmaceuticals (Cambridge, MA)
- …summary documents for regulatory submissions. + Oversees and/or independently performs PK , PD, and pharmacometric analyses including the interpretation of PK ... a quantitative field with some exposure to clinical pharmacology / PK -PD + MS with 12+ years' working experience in...in a quantitative field with some exposure to clinical pharmacology/ PK -PD + Preference will be given to candidates with… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …summary documents for regulatory submissions. + Oversees and/or independently performs PK , PD, and pharmacometric analyses including the interpretation of PK ... of working experience in a quantitative field with some exposure to clinical pharmacology / PK -PD + MS with 12+ years' working experience in a quantitative field with… more
- Charles River Laboratories (Shrewsbury, MA)
- …as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic assays, Luminex, Bioplex, ... of 6 years related experience in the development and/or validation of biomarker, PK and ADA assays is preferred (eg: ligand binding assays, enzymatic assays,… more
- Bristol Myers Squibb (Cambridge, MA)
- …team, providing scientific and strategic direction. + Identify and implement appropriate PK /PD and disease models to support clinical candidate selection, human dose ... of autoimmune diseases is highly desirable. + Comprehensive understanding of PK /PD assessments and proven experience designing ex vivo studies for pharmacodynamic… more
- Pfizer (Cambridge, MA)
- …with at least 4 years of experience. + Strong technical proficiency in pharmacokinetic software such as Phoenix, NONMEM, and R. + Excellent communicator with strong ... Experience in global regulatory agency interactions. + Ability to apply pharmacokinetic and pharmacodynamic concepts, including modeling and simulation, to clinical… more
- Sanofi Group (Cambridge, MA)
- …studies with CROs and performing analyses + Direct experience conducting in vivo PK , PD and efficacy studies + Experience in regulatory documentation preparation + ... Demonstrated ability to lead cross-functional teams + Experience analyzing data using computational approaches **Skills and competencies** + Advanced technical mastery with ability to be hands-on, provide guidance, troubleshoot complex problems, and train… more
- Sanofi Group (Cambridge, MA)
- …ocular disease models in AMD, glaucoma, DME, DR, etc. + Experience conducting PK , PD and efficacy studies in ocular models + Experience with automated methodologies ... for tissue analysis such as automated nucleic acid and protein extraction from tissues and automated histology - IHC, IF, ISH. + Experience with therapeutic modalities including small molecules, biologics, proteins, nucleic acids, and gene therapies +… more
- Pfizer (Cambridge, MA)
- …of emerging program targets, priorities and status. + Implementation of PK -guided dose escalation, early combination strategies and emerging innovations on all ... Pfizer Oncology first-in-human clinical trials with input from Oncology Research Unit, Oncology Regulatory Strategy, Clinical Pharmacology and Precision Medicine, Oncology Clinical Development and Operations, Pharm Sci and Product Teams. + Oversee the… more
- Takeda Pharmaceuticals (Boston, MA)
- …model development and deployment, miniaturized high-throughput ADME screens, and real-time PK simulation. Required Qualifications + Minimum 10 years' experience in ... the pharmaceutical drug discovery process, with a focus on ADME studies. + Proven leadership and experience in scientific workflow design and process optimization, particularly within automation, digital integration, and AI/ML solution implementation in ADME… more
- Takeda Pharmaceuticals (Boston, MA)
- …on- and off-target activity, physical properties, pharmacokinetics / pharmacodynamics ( PK /PD), and synthetic feasibility + Implement and execute innovative ... computational methodologies and tools such as AI-based drug discovery, state-of-the-art commercial and open-source software tools/methods + Mentor junior computational chemists on molecular design best practices + Open to traveling and spending time on both… more