- 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
- 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)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality... Clinical Practices (GCPs). The role partners with Clinical Development , Clinical Operations, Medical… 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
- Merck & Co. (North Wales, PA)
- …Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary… more
- Merck & Co. (North Wales, PA)
- …Involved in research activities for innovative statistical methods and applications in clinical trial development . Education and Minimum Requirement: PhD or ... research activities and in application of novel methods to clinical trial development . Preferred Skills and Experience : Publications in peer reviewed… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director... clinical development projects; andAssist the Senior Director in ensuring that appropriate corporate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for … 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)
- …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. (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)
- …and impact to key stakeholders. He or she will aid in the construction of clinical development plans, clinical protocols, and in submission of certain ... plan documents, biomarker data analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in the submission… 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
- Eisai, Inc (Philadelphia, PA)
- …management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies ... and oncology, with a strong emphasis on research and development . Our history includes the development of...profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,… 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… more
- Merck & Co. (North Wales, PA)
- … data/medical protocol deviations in collaboration with the Clinical Director . Collaborate cross-functionally in the development of the study protocol ... in Life Sciences plus 5 years relevant experience in pharmaceutical and/or clinical drug development or a Master's degree (or US equivalent) in Life Sciences… 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
- Merck & Co. (Rahway, NJ)
- …management reviews, plan budgets and track commercial launch/competitive landscapes & clinical development progress.Provides access leadership and input on ... Job DescriptionWe are currently recruiting for a Director , Global Oncology Market Access.The Director ...cross functional leadership across access, commercial and Research & Development to conduct and update key market assessments, build… more
