- Eisai, Inc (Nutley, NJ)
- …well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual primarily will be accountable for the ... information collection and sharing across oncology programs.Statistical lead of biomarker analyses and related activities of individual clinical programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team ... Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study(ies);… more
- Eisai, Inc (Nutley, NJ)
- …using statistical and machine learning methods to guide patient stratification and biomarker selection in clinical trials. Establish, develop, and implement ... your profile, we want to hear from you. The Clinical Data Science team at Eisai, Inc., is expanding...communication and collaboration skills, with the proven ability to lead and mentor in a multidisciplinary team environment. Previous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker , PK / PD ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- BioAgilytix (Boston, MA)
- …life-changing, life-saving therapeutics to the patients who need them.In this role, you will lead the development and validation of Biomarker assays to bring new ... setting.As a Scientist your day-to-day activities will include:Develop and validate Biomarker assays for novel therapeuticsPlan and direct experimental design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … biomarker /PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management from a medical perspective -Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team consisting ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , cross-functional ... discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, ... with internal and external stakeholders (eg Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics, etc.) to optimize data collection services on… more
- Merck & Co. (Rahway, NJ)
- … development leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic ... individual may also support precision medicine needs including new biomarker technologies, digital pathology, antibiotic diagnostics, and our companion diagnostic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary As Translational Strategy Leader, you will define and lead cross-project translational strategy and guide research across immunology related ... in specialty medicine. Responsibilities include: (1) review available translational and clinical results, both from internal as well as external research, (2)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... with internal and external stakeholders (eg Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics Partners, etc.) to optimize data collection… more
- Merck & Co. (Rahway, NJ)
- …approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and ... biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …here required.-7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation ... development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in...the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management from a medical perspective- Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team consisting ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
- Merck & Co. (South San Francisco, CA)
- …in vitro and in vivo modelsSolid understanding of drug discovery and clinical development and working knowledge of biomarker discovery, translational research, ... strategic plan within CMD, including integration of new technology platforms, pre- clinical models, human biology, data science, while focusing on uncovering novel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads ... primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within… more
- Integrated Resources, Inc (Atlanta, GA)
- …observational or clinico-genomic data from Tempus and publicly available databases (eg, TCGA, clinical trials, etc). . To lead or co- lead development ... with biomarker scientists and scientists from other functions including clinical pharmacology, biology, bioinformatics, clinical research, and clinical … more
- BeiGene (San Mateo, CA)
- … biomarker science, biomarker operations.** **Essential Functions of the Job:** ** Lead clinical biomarker , clinical translational research and Dx ... to Vice President, Head of Translational Discovery, Research and Medicine, and lead global Clinical Biomarker and CDx development team, including clinical… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …digital endpoints, shaping the future of clinical research. As a Digital Biomarker Lead you will be overseeing aspect of sensor-related research, from ... novel treatments that enhance patient lives. As a Digital Biomarker Lead reporting to Head of Digital...and usability aspects of V3 framework (Verification, Technical & Clinical Validation). + Lead on device-facing aspects… more
