- Merck & Co. (Rahway, NJ)
- …involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the entire cycle of ... research project teams relevant to the development of new compounds The Senior Clinical Director may: Oversee the Clinical Directors and supervise… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionGlobal Senior Director Medical Affairs (GDMA) - Daiichi Alliance, OncologyThe Global Senior Director Medical Affairs (GDMA) is responsible ... from key countries and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label)… more
- Merck & Co. (Rahway, NJ)
- …recommendations regarding commercialization strategies, portfolio prioritization and sourcing, clinical development /research strategies, and Business ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director , Business Development Execution, the primary function includes coordinating ... and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.- These agreements include but are not limited to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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. (Rahway, NJ)
- …medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work… more
- Merck & Co. (Rahway, NJ)
- …commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...scientific role tasked with working closely with the group Director to define group strategy and to lead a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, BDM… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety...safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...study level time, cost and quality deliverables. Lead the development of the clinical study plan including… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, NJ)
- … sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic ...or regional project or be partnered with a more senior project manager in support of a larger, more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... medical education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with ... strategies for that therapeutic area.She/He will strategize and execute Phase IV clinical development programs for assigned products.Design and review IIS… more
