- 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)
- …interpretation of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct and indirect ... Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 … more
- Merck & Co. (Boston, MA)
- …opportunity for a physician-scientist to join our group as a- Principal Scientist ( Clinical Director ) in Translational Medicine/Early Clinical Development in ... MA).Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with our… more
- Merck & Co. (Rahway, NJ)
- …Description: Director , Analytical R&D and Process R&D, Development Sciences & Clinical Supply Finance The Director will oversee a team of five ... for two areas:Analytical Research & Development within Development Sciences & Clinical Supply (DSCS):- organization is responsible for analytical method development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)MD with board… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and… more