- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Director , Clinical Development Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world ... including patients, physicians, and employees. Description: Sun is seeking a Director , Clinical Development within its Clinical Development… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Clinical Director will manage the entire ... and joint internal/external research project teams relevant to the development of new compoundsThe Clinical Director...relevant to the development of new compoundsThe Clinical Director may:Work closely with a cross-functional… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...area of responsibility. To accomplish these goals, the Senior Clinical Director may: Author detailed development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy.Responsibilities- Accountable for developing the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… 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, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical … 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, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… 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 ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical … 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. (Rahway, NJ)
- …medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior/Executive Director in ensuring that… more
- Merck & Co. (Rahway, NJ)
- …country teams to ensure patient access objectives and strategy are linked to clinical development , commercial and value evidence plans.In partnership with global ... Vice President, Global Market Access, Global Pharma, the Executive Director , Global Market Access, PAH and Rare Disease will...with the cross functional team including marketing and Product Development Teams (PDTs), (ex. clinical , OR and… more
- Merck & Co. (Rahway, NJ)
- …Involved in research activities for innovative statistical methods and applications in clinical trial development . Education and Minimum Requirement: PhD or ... in statistical research activities and in application of novel methods to clinical trial development . Preferred Skills and Experience :Publications in peer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development . Responsibilities Designs and leads clinical trial ... as other research areas centered around rare diseases and immune disorders. Director , Diagnostic Sciences Global Companion Diagnostics Job Summary The Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).Responsibilities:Write critical, complex ... centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex ... research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role responsible for producing… more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
- Merck & Co. (Rahway, NJ)
- …best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This ... Oral Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's… more
