- Merck & Co. (Rahway, NJ)
- … Clinical Development Finance Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide ... and analytical support to our Research & Development Division Oncology Clinical DevelopmentForecast grant spend as well as provide financial support related… more
- Merck & Co. (Rahway, NJ)
- …Respiratory projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and… more
- Merck & Co. (Rahway, NJ)
- …our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and ... high-quality data to support decision making in clinical trials.- Responsibilities :This position provides high quality statistical programming analysis and… more
- Merck & Co. (Rahway, NJ)
- …and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global... Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionBiologics Process R&D Associate ScientistOur Research Scientists are our Inventors.- Using innovative thinking, state-of-the-art facilities, and ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Merck & Co. (Rahway, NJ)
- …aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of ... facility - improvement activities. Position Qualifications: Education Minimum Requirement: Associate in Science, Associate in Applied Science...or higher degree in a relevant technical field of study plus at least six (6) years of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the ... improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study teams,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... documentsServes as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to ... and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction... Study Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Associates (SAs) or Senior SAs who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), ... and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in departmental and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Serves as a subject matter expert in medical codingReviews/approves clinical study related documents pertaining to medical coding and ... Position manages the end-to-end delivery of medical coding data for assigned projects/ studies collaborating with clinical and medical teams, CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study : provide input on the development of study protocol ... The position will act as main statistical contact for the assigned studies , in particular in cross-functional Study team(s).Responsibilities- Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …KPIs, KRIs, KQIs across all RD LFs. Define Cycle Times, Identity key milestones at Study , Country, and Site Level to gauge clinical trial performance. Build and ... and roles. Candidate will be responsible for managing external Benchmarking Study Submissions and seeking out external competitive intelligence to provide line… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications.Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document ... research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into systems (disease) modelsContribute to the design, execution and interpretation of clinical and non- clinical studies .Partner with external groups to ... centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within...to develop QSP modelsSome experience in the design of clinical and non- clinical studies used… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements for diagnostics and devices.Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, ... dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker,… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. If you're… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or ... and approvals. Support regular vendor/sponsor discussions to identify risks and ongoing study support.Ensures on time site shipments for subject and patient dosing,… more
