- J&J Family of Companies (Cambridge, MA)
- …for treatment response. + Develop interpretable models that aid in biomarker discovery and validation, enhancing the understanding of disease mechanisms. + ... + Demonstrated experience with clinical or questionnaire data analysis and/or biomarker data, including molecular, digital, or imaging-derived features. + Strong… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK, PBPK and ... PK/PD. + Work with formulation development groups and provide support for PK and PK/PD activities related to formulation development, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations. + Manage **pharmacometrics** activities… more
- Bristol Myers Squibb (Cambridge, MA)
- …Informatics and Predictive Sciences and Early Clinical Development to generate biomarker and patient enrichment hypotheses to enable efficient decision making in ... early clinical trials. We are optimally positioned to complement the world-class translational expertise, biology and leading academic research centers in the area. **Position Summary:** The Director of Cancer Immunology within the Oncology TRC at BMS will… more
- Bayer (Cambridge, MA)
- …collaboration with partner functions such as Disease Understanding Precision Biomarker (DUPB); + Provide the medical/clinical assessment justifying the First-in-Man ... application for approval by the Joint FiM/Tox Release Conference; + Conduct ongoing benefit/risk assessments from FiM until PoC, based on thorough clinical understanding of the targeted indication and medical need, as well as medical/clinical interpretation of… more
- Bristol Myers Squibb (Cambridge, MA)
- …of the tumor microenvironment, is required. + Extensive knowledge of high-content biomarker platforms and good understanding of the current clinical practice in ... early and late stage lung cancer + Ability to work in a fast-paced environment with rapidly changing and competing priorities and ambiguity. + Strong team player with the ability to work in cross-functional teams. Excellent communication and collaboration… more
- Sanofi Group (Cambridge, MA)
- …and conduct in vitro and in vivo mechanism-of-action, proof-of-concept, and biomarker studies to validate targets and evaluate therapeutic strategies + Develop ... assays and collaborate cross-functionally to screen preclinical candidates of diverse modalities using target- and disease-relevant functional readouts + Design and conduct in vitro and in vivo studies to evaluate the pharmacology and efficacy of preclinical… more
- Astrix Technology (Boston, MA)
- …maintaining focus on patient safety and treatment efficacy. + Drive biomarker strategy, including RNA, genomic, proteomic, and imaging-based markers. + Contribute ... to global regulatory submissions (eg, INDs, CTAs) and provide medical input in alignment with FDA, EMA, and ICH guidelines. + Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs, to integrate and execute… more
- Bristol Myers Squibb (Cambridge, MA)
- …in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs + ... Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review… more
- Pfizer (Cambridge, MA)
- …appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans. + To ensure the clinical components of the clinical ... plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials. + To support projects from Research to Proof of Concept at which point molecule may be handed to the late-stage Oncology Clinical Development team for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …support in the design, analysis, and interpretation of preclinical and biomarker studies to enable quantitative decision making + Collaborate with cross-functional ... project teams, including Computational Biology, Pharmacokinetics, and Safety scientists to explore methods and implement discovery strategies to enable data-driven decision making. + Apply frequentist, Bayesian, ML/AI fit-for-purpose statistical analyses… more