- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, Biomarker , CDx, Clinical Supplies, central labs); Must have strong problem-solving skills and ... is able to work in complex categories. Assist in the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and Relationship Management - Leads contract related… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ... ensure successful 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 globallyFor late-stage programs, executes the… 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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …human disease to support investment in full developmentDevelopment of biomarker strategies through cross-functional teams that provide line-of-sight from ... clinical strategy for novel therapeutics including authoring initial clinical biomarker plans, early clinical development plans, and clinical pharmacology studies… 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
- Genmab (Yardley, PA)
- …expertise in histopathological evaluation, tissue-based assay development (IHC, ISH, IF), biomarker strategy and toxicologic pathology for a variety of antibody ... etc) a variety of immunohistochemical stains for target screening and biomarker assessment. Serve as in-house expert representing Genmab in interactions with… more
- Careerbuilder-US (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 individual who is capable of multitasking projects in a collaborative environment. Job includes, but is not limited to: * RNA/DNA isolation from various tissues/cells from human, non-human primate, and rodents. * Targeted gene expression profiling… more
