- BeOne Medicines (San Carlos, CA)
- …The Advanced Analytics team at BeOne is seeking an Associate Director , Pipeline Analytics to drive data-driven insights into pipeline molecule analysis, ... decisions, and commercialization pathways. + Analyze clinical, preclinical, and biomarker data to identify differentiation opportunities for BeOne Medicines'… 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 (Boston, MA)
- …in championing innovation in technical areas. + Comprehensive understanding of biomarker strategies and implications for drug development. + Demonstrated track ... record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements). +… more
- Lilly (Philadelphia, PA)
- …clinical teams to ensure optimum integration of novel imaging and biomarker methods. **Purpose:** Through the application of scientific/medical training, clinical ... expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of clinical trials in support of clinical trial use, registration and commercialization of diagnostic… more
- Bristol Myers Squibb (Cambridge, MA)
- …informatics, computational and systems biology, patient selection and translational biomarker research, and broader fields including knowledge science, epidemiology ... and machine learning-across the full lifecycle of drug discovery and development and across all therapeutic areas at BMS. We do this in close partnership with scientific and clinical experts in the field, both inside and outside the company." We perform… more
- Bristol Myers Squibb (Princeton, NJ)
- …plan, and identifies/seeks input from TLs on emerging science in drug and biomarker research, disease knowledge and design of clinical protocol and programs + ... Provides input into data generation; ad-hoc, secondary and exploratory analyses + Provides data dissemination via data rollout plans and training + Provide medical review of asset content to align with overall strategy. + Provide Medical input/perspective at… more
- J&J Family of Companies (Raritan, NJ)
- …to health agencies + Close collaboration with discovery on target identification, biomarker strategies, and NME criteria + Overseeing active medical and scientific ... contribution to matrixed cross-functional Early Compound Development Teams and Clinical Teams + Formulation and implementation of early Clinical Development Plans, including trial design and endpoints . Working with functional partner leadership (eg, Global… more
- Astellas Pharma (Northbrook, IL)
- …critical documents. + Able to assimilate Research, Clinical Pharmacology, Biomarker , medical safety, Toxicology (early phase programs) regulatory, biostatistics, ... medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs. + Responsible for managing the process of development of protocol and necessary regulatory documents. + Accountable and responsible for… more
- Taiho Oncology (Pleasanton, CA)
- …of cross-functional areas (eg, clinical operations, biostatistics, data management, biomarker , pharmacovigilance, quality, etc.) + Knowledge in authoring key ... clinical development documents (eg, study protocol, IB, ICF, CRF, CSR, DSUR, PBRER, and documents for regulatory interactions). + Ability to learn, integrate complex information, and manage competing priorities for program deliverables + Excellent presentation… more
- Astellas Pharma (Northbrook, IL)
- …clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and ... statistical programming. + Good knowledge of medical literature, clinical, regulatory, and commercial landscape. **Salary Range** $170K - $240K (NOTE: Final salary could be more or less, based on experience) **Benefits:** + Medical, Dental and Vision Insurance… more
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