- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Serves as a primary source of medical accountability and oversight for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts ... in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CMC and other appropriate groups ... and external panels related to Health Authority initiatives. Review of clinical study protocols, health authority dossiers and briefing books. Qualifications:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational… more
- Merck & Co. (Rahway, NJ)
- …company's innovations and improve patient health outcomes. Under the guidance of a senior leader, this individual will support one or more V&I, Outcomes Research ... to value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel are ... oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head ... solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Eisai, Inc (Nutley, NJ)
- …is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific ... including physiologically-based pharmacokinetic (PBPK), quantitative system pharmacology (QSP) models, clinical trial simulations, literature meta-analysis, machine-learning/deep learning and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… more
- Genmab (Plainsboro, NJ)
- …our purpose.Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director , Global Drug Safety & Pharmacovigilance Physician serves as the safety ... in audit and inspection activities as relevant.Requirements MD required; clinical research and/or fellowship training in oncology/hematology, pharmacology or other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future,...within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and … more
