- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are 1) to ensure the timely execution of biomarker tests on samples from clinical trials and 2) to perform technical and ... strategic assessment of new and innovative biomarker platforms. This position requires knowledge in cancer biology, broad technical expertise, and direct experience… more
- Aequor (South San Francisco, CA)
- …to develop machine learning modeling and prediction pipelines using multi-modal biomarker data from clinical trials. Responsibilities Maintain and develop in-house ... of clinical response and resistance, extend analytical capabilities of biomarker platform Define and implement Bioinformatics strategy and protocol-driven… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration with TMCP, Collaborates with external KOLs to ... responses to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker , PK / PD measurements, Reviews emerging clinical data regularly, Leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on clinical matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration with Translational Medicine, Collaborates with external… more
- Merck & Co. (North Wales, PA)
- …of Phase I/II oncology clinical trials as well as translational biomarker analyses. This position requires strong communication skills, interpersonal skills and ... analyzing data from clinical trials as well as analyzing oncology biomarker and clinical data.-Coordinate all statistical activities for ongoing clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker , ... companion diagnostic and other device to optimize access to patients.Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and is viewed as an expert in its application to the regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in ... to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she ... QSP models to aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly… more
- Careerbuilder-US (Foster City, CA)
- …$ 60 /hour on W2. Job Description: FUNCTION: Clinical Operations - Biomarker and Bioanalytical Operations Position overview: Clinical Operations is responsible for ... or manage components of Phase I, II or III studies . Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates… more
- Nesco Resource (Santa Clara, CA)
- Onsite Position - Local Candidates Job summary: The Experimental Biomarker Research and Early Development team (discovery sciences) in Santa Clara, CA at Roche ... will join a cross functional team of scientists developing a new biomarker detection and feasibility. Essential job functions: Works under general supervision to… more
- Merck & Co. (Boston, MA)
- …and ex vivo assays at scale to support potential compound screening, biomarker identification and mechanism of action studies.Evaluate the pharmacology of novel ... molecules, peptides, antibodies and other modalities for therapeutic potential in immunology, oncology or cardiometabolic indications.Potential involvement in ex vivo translational model establishment.Maintain timely, accurate laboratory records of activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study concepts as needed. Partners with RWE and HEOR strategy and Biomarker /CDx leads on related integrated evidence generation strategies and activities as part ... of the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across USOMA functions to develop,… more
- Aequor (San Diego, CA)
- …incumbent will be responsible for drug screening, cell-based assay development, and biomarker discovery. The individual will be responsible for the execution of ... defined experiments and data analysis. The position will require handling of tumor cell lines, blood samples, and patient-derived tissues. The associate will be expected to maintain an electronic lab notebook and organize results into reports or presentations.… more
- Merck & Co. (San Diego, CA)
- …support target validation, drug screening, mechanism of action studies, and biomarker identificationKeep detailed and concurrent records of experiments performed in ... an ELN, analyze and interpret data, and design subsequent experiments to address new questions that are raised.Present data to peers and management to facilitate collaboration and data-driven decision makingWork collaboratively with other scientists in the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ... ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyCreates a forward-looking Diagnostic… more
- BioAgilytix (Durham, NC)
- …of GxP regulations IA role: Experience with execution of PK/ biomarker /ADA assaysCB role: Experience with execution of potency/NAb assaysWorking Environment:Primarily ... laboratory environmentExposure to biological fluids with potential exposure to infectious organismsRare exposure to skin and lung irritants, toxic materials, and hazardous wastePersonal protective equipment required, such as protective eyewear, garments, and… more
- Merck & Co. (Rahway, NJ)
- …implementation of commercial diagnostic strategies for our immunology assets with biomarker and diagnostic associated indications. The candidate will work in close ... collaboration with Brand Leads and Business Leads in Global Immunology Marketing as well as the Diagnostic Development Teams in Our Research Laboratories to ensure cross functional alignment through clinical development and successful commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of standards across a project.Ensures modern core data sources (ex: Biomarker Data, Medical Devices Data, etc.) are effectively developed in compliance ... with CDISC / SDTM industry standards for diverse DS Programs operating under the outsourced and in-house operating models. - Functional Expertise:Lead data standardization initiatives to ensure DS Programs and Protocols comply with Therapeutic standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 forward-looking Diagnostic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required. TravelMust have the ... ability to travel up to 10% domestic and internationalDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race,… more
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