- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary information to author the ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project ... biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, … more
- Eisai, Inc (Nutley, NJ)
- …milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) ... programs, and will be the clinical group leader for the ongoing and planned development ...Director (or equivalent role) with Global Clinical Lead or Clinical Program Director… more
- Formation Bio (New York, NY)
- …and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our… more
- Merck & Co. (Rahway, NJ)
- …the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are ... clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a...software for planned analyses and ascertains needs for potential program development of novel statistical methodology.7. Analyzes… more
- Formation Bio (New York, NY)
- …direction, and support to cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the program ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck... manager who can oversee at least one drug development program , managing multiple workstreams while ensuring… more
- Merck & Co. (Rahway, NJ)
- …regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ... and/or out-of-specification approval, change management approval, etc.Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of ... and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … more
- Merck & Co. (Rahway, NJ)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and ... collaboration with senior cross-functional leadership to optimize efficiencies in the clinical development space. Preferred skills include experience in the… more
- Merck & Co. (Rahway, NJ)
- …The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or ... 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)
- …incumbent will contribute to creation and improvement of Clinical Development processes. Job Description:Execute an overarching safety program tailored for ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA… more
- Merck & Co. (Rahway, NJ)
- …and address drug delivery challenges Demonstrated understanding of connectivity between clinical development , chemistry, manufacturing and control (CMC) and ... Material(s):Required Skills:Adjuvants, Adjuvants, Animal Vaccination, Chemical Biology, Chemical Engineering, Clinical Chemistry, Data Analysis, Development Projects, Drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …therapeutic areas (TAs) and segmentation to inform actionable plans. KOL Experience Strategy: Lead the development and execution of KOL experience strategies and ... The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping...and support for the brand/therapy area. Thought Leadership Programming: Lead the development and execution of thought… more
- Eisai, Inc (Nutley, NJ)
- …up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May ... and oncology, with a strong emphasis on research and development . Our history includes the development of...and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Regional Thought Leader Liaison (RTLL), Alzheimer's Disease will lead and execute regional and local ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partner cross-functionally with multiple functions and groups throughout the US organization, Clinical development , Research & Early Development , other ... Functions Strategy, Planning, Performance and Tracking Elevate Portfolio congress, speaker program and market development strategy, plans and execution aligning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partner cross-functionally with multiple functions and groups throughout the US organization, Clinical development , Research & Early Development , other ... more patients than ever before. The Position The Rare Disease Marketing Operations Lead is responsible for assisting the Rare Disease Commercial Strategy & Marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the highest quality standards. This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports ... work in close collaboration with Japan. This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global… more
- Merck & Co. (Rahway, NJ)
- …Electronic Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development , High Performance Team Building, Human Resource ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & … more
