- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical ... Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion ... method review) Facilitates integration of the US PED strategy into clinical development programs, post-authorization and commercial research activities and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... Responsible for driving best in class solutions while driving budget and program efficiencies. This individual will maintain a high-level of collaboration and… more
- Merck & Co. (Rahway, NJ)
- … clinical and development related meetings.- Working independently, the Program Clinical Supplies Project Manager designs strategic and operational plans ... organizations (as a lead Global Clinical Supply Planning program representative) such as clinical development , regulatory, quality and other supply chain… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …therapeutic / franchise area(s). Relationships Reports to the Executive/Senior Director of Value Communication and Contracting Strategy. Interacts frequently in ... Oversees and leads pricing and contracting strategy, playbook, and guideline development for all new product launches within responsible therapeutic area, with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.) across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Medical, Clinical Development , Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to meet needs of ... for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
- Merck & Co. (Rahway, NJ)
- …and bringing subject matter expertise related to model informed drug discovery and development for programs .- The Senior Director in Pharmacometrics should ... and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … more
- Merck & Co. (Rahway, NJ)
- …capabilities through the following responsibilities.Responsible for achieving results on major program deliverables by identifying, driving the development and ... Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research vendors, & budget management. RelationshipsThe fellow will report to the Senior Director RWE during the program and will work closely with all ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- …of potential investigators for consideration for participating in phase II-IV clinical development programsIn response to unsolicited requests from scientific ... collaboration to further differentiate our portfolio.The Oncology Regional Medical Scientific Director , RMSD, is a credentialed (ie, MD, PhD, or PharmD) therapeutic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and its activities thereby increasing their desire to partner with North American Clinical Development (NACD) Engage and provide additional value by advising and ... and Site Networks. Relationship This role reports into the Director of Site & Patient Engagement. Essential Functions Establish...clinical monitoring / site management Solid knowledge of clinical development processes with emphasis on site… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... and Quality by Design principles, and advanced data analysis for drug development applications.-The Director selects, trains, and effectively works with… more
