- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development . Internal relationships include ... About the Department The Clinical , Medical and Regulatory (CMR) department...Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical &… 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 ... AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Merck & Co. (North Wales, PA)
- …Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Executive Director /Associate Vice President in… more
- Eisai, Inc (Philadelphia, PA)
- … Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of ... and oncology, with a strong emphasis on research and development . Our history includes the development of...Salary Transparency Language:The base salary range for the Associate Director / Director , Medical Science Liaison, East… more
- Tris Pharma (Monmouth Junction, NJ)
- …of Good Clinical Practices (GCPs). The role partners with Clinical Development , Clinical Operations, Medical Affairs and R&D Quality Assurance to ... Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance....Medical DevicesExperience in developing SOPs , reviewing internal clinical , regulatory, and medical processes to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/ medical contributor; For large or complex… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product ... pipeline.The Director will report to the Executive Director of Sterile Product Development - Mixed... with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within ... Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical ...Speakers' Bureau, including presentations at Speaker Training and Curriculum Development meetings Provide medical review of all… more
- Merck & Co. (North Wales, PA)
- …and data sharing with external researchers. - The Director , Informed Consent Medical Writer (ICMW) is responsible for the development and management of ... Job DescriptionThe Medical Writing & Disclosure Department of the GCTO...a variety of regulated documentation in support of the clinical development portfolio and compliance in public… more
- Merck & Co. (North Wales, PA)
- …state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs ... Involved in research activities for innovative statistical methods and applications in clinical trial development . Education and Minimum Requirement: PhD or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of ... areas centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction,… more
- Merck & Co. (North Wales, PA)
- … Director , or Director level personnel responsible for oncology clinical development programs or projects. Work closely with a cross-functional group ... Associate Vice President will manage and oversee the entire cycle of clinical development , including study design, initiation, execution, monitoring, analysis,… 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
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... and oncology, with a strong emphasis on research and development . Our history includes the development of...you.The Northeast Region covers NJ, PA, & DE.The Associate Director , Regional Thought Leader Liaison (RTLL), AD Marketing will… more
- Merck & Co. (Rahway, NJ)
- …EDSA leads a large investigator-initiated studies program in partnership with late-stage development teams in Medical Affairs while also supporting early-stage ... Job DescriptionThe Executive Director , Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific...development teams. The role also partners with Medical Affairs leadership to develop the global Value Evidence… more
- Merck & Co. (Rahway, NJ)
- …cross functional team including marketing and Product Development Teams (PDTs), (ex. clinical , OR and medical affairs), regional and country teams to ensure ... patient access objectives and strategy are linked to clinical development , commercial and value evidence plans.In partnership with global and regional and… more
- Merck & Co. (Rahway, NJ)
- …customer relationships and support the goals of the companion animal business through medical education and business acumen. The Associate Director partners with ... build strong customer relationships and advance our company's offerings through medical education and needs discovery.Provide professional development by… more
