- 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)
- …to manage clinical development projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate corporate ... activities involving investigational compounds in Immunology. With a focus on late-stage development , the Clinical Director will manage the entire cycle of … more
- Merck & Co. (Rahway, NJ)
- …commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of ... results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical … more
- Merck & Co. (Rahway, NJ)
- …regulatory affairs, statistics, and manufacturing to manage clinical development projectsAssist the Senior /Executive Director in ensuring ... 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)
- …DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... will be responsible for resourcing planning, risk assessment strategies, talent development , and partnering to build a culture of innovation and inclusion.-The… more
- Merck & Co. (Rahway, NJ)
- …teams to inform executive decision making through analytics support for clinical development , business development and alliances/partnerships decisions.The ... engineering, or business-related field.3+ years of experience in marketing, clinical development , advanced analytics, asset portfolio management, strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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)
- …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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, BDM and… 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...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Senior Director , Quantitative Systems Pharmacology (QSP) will work within the ... This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP.Responsibilities:Develop… 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)
- …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)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA ... in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role ... of the progress includes the stakeholders at the Alliance Partner.- Drive the development of Areas of Interest (AOI) for Externally Sponsored Research (ESR). Align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area ... requirements/precedence.Represent Daiichi Sankyo's regulatory group in internal and external development project meetings.Provide guidance to peers and cross-functional team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
