- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... our pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development… 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)
- …time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior Director in the General Medicine ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with...single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Provides leadership to… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Oncology Market Access.The Director will be developing and executing the market access & ... colleagues to lead critical access pillars throughout commercial plans and senior management reviews, plan budgets and track commercial launch/competitive landscapes… 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
- 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …ADHD portfolio and product launch. We have a position available for a Senior Director / Director , National Sales (NSD) to lead approximately 100-person ... managers to effectively deliver information on our products to Healthcare Professionals.The Senior Director / Director , National Sales (Sr NSD) provides… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… 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
