- 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 ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... trials within an indication or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health commercialization teams.Contributes to the development of a single… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing the multiple ... data integrity, site scientific engagement, and HA responsesInteractions with the internal clinical study physicians and physician scientists as well as external… more
- Merck & Co. (Rahway, NJ)
- …Research & Development pipeline while gaining relevant experience supporting functions in Global Clinical DevelopmentInfluence and impact clients by helping to ... lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior...including the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective ... Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... and Clinical Directors responsible for the design and medical monitoring of clinical studies .Ensure optimal design and monitoring of clinical programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in and ... at a project level, and interacts with regional and global project team members, senior management, and...as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... for protocol profile, protocol and amendments for small, uncomplicated clinical studies ; Coordinate sponsor medical monitors across...Study Team (IST) representative or IST leader on study team; Responsible before senior management for… more
- Merck & Co. (North Wales, PA)
- …Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator's brochures, clinical sections ... Job DescriptionPosition Description: Senior Medical Writer The Senior Medical...Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (eg, clinical study… more
- Merck & Co. (North Wales, PA)
- …program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.- ... to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.-Is responsible for planning and ensuring… more
- Merck & Co. (Boston, MA)
- …downstream to development partners. We further utilize our expertise to develop and study prototype formulations intended for clinical use, and deliver robust ... conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our...team in Boston, MA is seeking a highly motivated Senior Scientist for a lab-based role with creative passion… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and...regulatory interactions at project level, interacts with regional and global study and project team members, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Budget; Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director, GMA Oncology ( Global Medical Affairs team lead for compound), is ... insights.- Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- Eisai, Inc (NJ)
- … strategies. Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor ... management; providing guidance to study teams on vendor selection and management options in...and managing service provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance… more
- Lundbeck (Bothell, WA)
- …is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
