- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , ... centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational...1-3 clinical trials at the study and program level. Responsible for clinical program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... required Proven track record in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …professionals, HAs, ECs, DMCs, and Academia. L ine management responsibility of Director /Associate Director Global Safety Lead, Senior Global Safety ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… 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
- Merck & Co. (Rahway, NJ)
- …subject matter expertise related to model informed drug discovery and development for programs .- The Senior Director in Pharmacometrics should provide ... leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the Executive Director , Medical Affairs and will assist the Executive Director and Senior Director (where applicable) in managing multiple internal ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical...for select clinical trials, in collaboration with Clinical Director and Clinical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work in a growing Clinical Operations Department that manages multiple early-late stage clinical programs . The Senior CPM will be responsible for all ... facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical ...difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required Experience leading cross-functional teams in the execution of cardiovascular clinical trial portfolios/ programs (ie heart failure) Expert in ICH-GCP ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …information to internal and external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US ... facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical ...support programs from early research through late-stage clinical development. We are building for the future, creating… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Rahway, NJ)
- …submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.Lead/support/oversee clinical supplies production with ... and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.--… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Responsible for driving best in class solutions while driving budget and program efficiencies. This individual will maintain a high-level of collaboration and ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Genmab (Plainsboro, NJ)
- …position is hybrid based in Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the development of Global ... 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… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle management activities ... (CV&R). The incumbent will be expected to lead multiple programs including those new to the organization therefore requiring...development of assets within the Respiratory Section of Global Clinical Development May serve as a senior … 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 ... and budget negotiations through understanding and tactics to develop, execute and deliver clinical studies/ programs on time with a focus on budget, compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for aligned therapeutic / franchise area(s). Relationships Reports to the Executive/ Senior Director of Value Communication and Contracting Strategy. Interacts ... frequently in collaboration with internal management and senior level managed markets customer representatives. Interacts internally with team representatives from… more
