- 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)
- …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)
- …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
- 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)
- … 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
- 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)
- …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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …not limited to, case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all ... Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a...more senior staff, may serve as the data management lead or perform a support role for filing programs.… 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
- 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)
- …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)
- …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
- Merck & Co. (South San Francisco, CA)
- …to direct reports and peers.Solid understanding of drug discovery and clinical development.Working knowledge of biomarker discovery, translational research, and ... and across the network, as well as collaborating with key opinion leaders in academia. Lead the development and implementation of in vitro and in vivo assays to… more
- Merck & Co. (South San Francisco, CA)
- …to support basic research, preclinical and development activities and translational biomarker work. This high throughput lab requires an organized, highly motivated ... work including RNA isolation and gene expression profilingPresent and lead discussions on experimental results and data interpretationServe as Molecular… 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
- 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
