- 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
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the ... lead clinical programs across different diseases and supervising the clinical development team. This individual will be the primary point person for medical… 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
- 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.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
- Merck & Co. (North Wales, PA)
- …treatment for adults with hypercholesterolemia to reduce LDL, which is currently in Phase 3 Clinical Development . The Director will work closely with the US ... Job DescriptionThe Director , US Pharma Payer Marketing Atherosclerosis leads a...performing Chapter of payer marketing associate directors through competency development and coachingCollaborate with IAM leadership and account executives… 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
- 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 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
- Merck & Co. (North Wales, PA)
- …Asset team. 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 Director , Executive Director… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This ... We are part of the research division, focusing on development and clinical deliveries in a GMP...FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical … more
- Merck & Co. (North Wales, PA)
- …Advanced degree (eg, MS, MBA, Ph.D., PharmD) preferredExperience and knowledge of clinical drug development strongly preferred; including the different phases of ... Job DescriptionThe drug development Project Manager is part of Global Project...organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …workManage Publication tracking and announcement, in coordination with Medical Director and Medical Information /Education functionContribute to development ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… 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)
- …This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP.Responsibilities:Develop ... script-based analysis packages to generate clinically relevant hypotheses to inform clinical development programsStay informed with emerging literature and… more
- Merck & Co. (Rahway, NJ)
- …on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory, ... shape, present and defend regulatory documents and submissions.Represent QP2 on discovery, early clinical development and late clinical development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...affairs projects within a specific compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy and execution… more
