- Merck & Co. (Rahway, NJ)
- …development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that ... tools, and predictive approaches to inform molecule, formulation, and process selection . In summary, our team enables the translation of preclinical candidates… more
- Merck & Co. (Rahway, NJ)
- …development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that ... tools, and predictive approaches to inform molecule, formulation and process selection . In summary, our team enables the translation of preclinical candidates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides information and insights to the lines of business Develops supplier selection criteria and facilitate team members through a disciplined strategic sourcing ... with suppliers to ensure optimal relationship with respect to product selection and delivery performance Establishes, directs and leads cross-functional teams in… more
- Merck & Co. (Rahway, NJ)
- …development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that ... tools, and predictive approaches to inform molecule, formulation and process selection . In summary, our team enables the translation of preclinical candidates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal vs. external manufacturing and CDMO selection , ... exit activity plan, etc.) based on a cross-functionally designed strategy, during (end-to-end) product life cycle.Develop (or have subordinates develop) activity plan, and budget for project in alignment with Unit strategy, plan, budget and CDP. Lead (or have… more
- Aequor (Thousand Oaks, CA)
- …readiness such at Product Governance (PG) Portals, format and scale, site selection decisions, life cycle management projects; and o Identifying and quantifying ... internal and external risks to the supply network and developing strategies to mitigate risk and create a more resilient supply chain. Engaging with leaders across manufacturing network, process development, supply chain, finance, and other functions to align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of standards initiative cross-functionally and externally. Contributes/participates in the selection of functional technologies, (MDR, CDR, EDC) thereby developing ... optimal approaches to support the collection of diverse clinical data. Develop necessary training materials, sessions, and facilitate lessons learned discussions within the department. Share new industry standards, best practices within department as required.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …study plan(s) including key milestones and timelines Ensure country and site selection meet study requirements Participate in the development and testing of clinical ... systems (eg, data capture, IxRS) Ensure internal and external systems are updated in a timely manner (eg, trackers, clinicaltrials.gov) Manage critical study documents, such as consent forms, study manuals, subject recruitment materials Oversee the Trial… more
- Merck & Co. (North Wales, PA)
- …and go-to-market strategies like positioning, segmentation, and target channel selection . Lead, collaborate and execute early US marketing activities including ... L3 Early, foundational market research, and market landscape mapping & analysis with key partners in collaboration with Global & US Marketing teams and OCAR. Monitor and evaluate the potential impact of external market trends and competitive dynamics, evolve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biosample shipments (eg working with cross-functional stakeholders for sample selection , managing shipment timeline, reconciling outbound and inbound sample shipment ... manifests, and tracking ad hoc shipments in trackers). Review the CRO partner Sample Management Plan, to document cross-functional agreements on the tracking, lifecycle and reconciliation plan for each sample type. Responsible for providing timely updates and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be required to partner with Senior Training Leadership in the identification and selection of vendors to support training priorities. Will be expected to serve as ... the lead with the vendor & project management requirements for initiative completion. They will lead the search for innovative training solutions to provide continuous improvement opportunities in the learning environment.Qualifications: Successful candidates… more
- Aequor (South San Francisco, CA)
- …data engineering, preferably in MHC genomics, target and neoantigen discovery and selection . Position Details This will be a full-time contract position for an ... initial period of 1 year, with the possibility of extension. This position is onsite or hybrid in the Pacific time zone. Responsibilities Maintain bioinformatics and data infrastructure for research projects related to individualized cancer immunotherapy… more
- Merck & Co. (South San Francisco, CA)
- …target identification and validation, lead optimization, preclinical candidate selection , and early developmentHighly skilled in complex cell-based assays/models ... for biomarker discovery and translation, utilization of lab automation, and deep expertise in mechanistic pharmacologyExperience leading discovery teams, setting strategy & priorities, and managing resourcesAn excellent track record of providing mentorship to… more
- Merck & Co. (Rahway, NJ)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated ability to identify, mitigate and clearly ... articulate program risks -Preferred Experience and Skills:Hands-on experience with physiologically-based pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product… more
- Merck & Co. (Rahway, NJ)
- …conventional and novel technologies.Designing scientific studies to inform the selection and deep understanding of synthetic routes, formulation compositions, and ... manufacturing processes.Implementing analytical methods for laboratory development, as well as release and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) conditions.Providing leadership not only on drug development pipeline… more
- Merck & Co. (San Diego, CA)
- …(mAb, single-domain Ab, multispecific Ab, etc) to support candidate selection and pre-clinical development of therapeutic programsContribute scientifically to drug ... discovery research programs; present and communicate strategies, concepts and results to multidisciplinary drug discovery teamsCollaborate with adjacent discovery departments to develop and integrate enabling technologyEnsure that data generated is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GPT for early-stage programs.Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships with Diagnostic ... PartnerProvides scientific and technical 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… more
- Genmab (Plainsboro, NJ)
- …summarize efficacy and safety data for interpretation/analysisParticipates in country/site selection , feasibility assessment and engage in KOL interactionAssists in ... the development of charters and provide support to coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, Adjudication and Safety Committees)Assists in the development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights strategy planning and synthesis such us, RFP development, vendor selection incl. associated due diligence, contract execution, budget management and ... delivering according to timelines Builds up a strong understanding of the organization and the different evidence needs and requirements from our Medical, Commercial and Market Access colleagues within the therapeutic area Works as an active contributor in… more
- Merck & Co. (Boston, MA)
- …and drug delivery research from target identification through clinical candidate selection for both small molecules and biologics. DPS influences molecular design ... of discovery compounds selected as clinical candidates through physicochemical property profiling and then applying insights to better understand, and resolve, drug product developability risks. We further utilize our expertise to identify and develop solid… more
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