- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical ... to IRBs and HA, Collaborates with Translational Medicine to ensure appropriate biomarker , PK / PD measurements, Reviews emerging clinical data regularly,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In ... apply QSP models to aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and… more
- Merck & Co. (Rahway, NJ)
- … development leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and Evaluation Job The Search and Evaluation (S&E) team is a core… more
- Insmed Incorporated (Bridgewater, NJ)
- …for the scientific guidance and design of the bioanalytical translational and clinical strategies and the execution (eg Biomarker ) of therapeutic programs ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global ... 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)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for 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 External Vendors for the data… 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 ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… 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, ... Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure)...plan within CMD, including integration of new technology platforms, pre- clinical models, human biology, data science, while focusing on… more
- Merck & Co. (Rahway, NJ)
- …approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and ... (translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global ... 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)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads ... and Regulatory Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally- Creates a… more
- Regeneron Pharmaceuticals (Boston, MA)
- The Associate Director , Clinical Imaging will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical trials where ... imaging biomarker strategies to advise and advance the Regeneron clinical pipeline. + Lead, design and implement multi-modality imaging measures as endpoints… more
- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Clinical Development Strategy Team Member is responsible for ... BI market approach and informs medical affairs efforts where applicable. The Director , Clinical Development Strategy Team Member collaborates cross functionally… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Clinical Project Scientist (1 of 2) - 2406180275W **Description** At Johnson & Johnson, we believe health is everything. Our strength in ... humanity. Learn more at https://www.jnj.com/ . We are currently seeking an Associate Director , Clinical Project Scientist (Oncology). This position is based out… more
- Highmark Health (Pittsburgh, PA)
- …:** The **Allegheny Health Network (AHN)** is recruiting a full-time Medical Director for our clinical cancer genetics program located in **Pittsburgh, ... state-of-the-art Academic Cancer Institute facility + Pioneering scientific, translational and clinical research with a new Genomics facility + Network of genetic… more
- Bristol Myers Squibb (San Diego, CA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director will be the clinical lead to progress multiple early ... Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies ** Clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director will be the clinical lead to progress early clinical ... Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies + Liaises… more
- Sanofi Group (Cambridge, MA)
- ** CLINICAL RESEARCH DIRECTOR , I&I** The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for ... the development, execution and reporting of clinical trials in support of the registration of a...input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge… more
