- 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) ... want to hear from you. The Executive Director, Global Clinical Development resides within the Oncology at...Director (or equivalent role) with Global Clinical Lead or Clinical Program Director… more
- Eisai, Inc (Nutley, NJ)
- …design/execution, and data monitoring to ensure successful implementation of high-quality clinical development programs. Lead and manage moderately complex ... profile, we want to hear from you. The Director, Clinical Development is a newly created role... research areas and may occasionally be responsible for program oversight.Serve as a medical monitor and provide input… 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
- 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
- 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
- Formation Bio (New York, NY)
- … program manager who can oversee at least one drug development program , managing multiple workstreams while ensuring seamless cross-functional coordination ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… 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)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... hear from you. The Regional Thought Leader Liaison (RTLL), Alzheimer's Disease will lead and execute regional and local engagement with existing and emerging Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality and/or timelines at the study level and escalates issues to the DM program lead .- Will manage DM resources of assigned studies; provides FSP/Vendor ... and issues and determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed.- Attends study team meetings and provides… 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)
- …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
- 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)
- …Portfolio Management, and/or Continuous Improvement- ( 40-60%): - In addition to Talent Development , may lead various projects within VIPM that would require: - ... Project Managers in Value & Implementation (which is this job), Development , and CMC; Discovery Portfolio Managers; Alliance Managers; Project Management Office… 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
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Program Leader sits within Clinical ... and interpretation of clinical trials. + The Clinical Development Program Leader will...overall portfolio view + Provide strategic insights into the clinical development plans + Lead … more
