- Novo Nordisk Inc. (Plainsboro, NJ)
- …with study protocol. Resolves or escalates major/cross- program issues, supported by Director of Clinical Operations Collaborate with the Clinical Trial ... NJ. We support programs from early research through late-stage clinical development . We are building for the...The Position We are looking to hire an Associate Director of Clinical Operations. This is a… 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)
- …of managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , ... 1-3 clinical trials at the study and program level. Responsible for clinical program...the associated budget meet the needs of the overall development plan agreed to by the Global Project Team… more
- 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
- 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
- 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)
- …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
- Genmab (Plainsboro, NJ)
- …experienced and dedicated Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be accountable for the medical ... of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP). Lead creation and… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… 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)
- …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
- Genmab (Plainsboro, NJ)
- …the value of assigned asset(s),Provide strategic market access input to inform global clinical development program of assigned asset(s) and ensure it ... is hybrid based in Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the development of Global Integrated… 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)
- …responsible for spearheading risk management efforts in combination product development , commercialization, and lifecycle management. This individual will oversee ... collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from… 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including critical path activities ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the… more
