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The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....

- Cranford, NJ

Global Pharmaceutical company is hiring a \ for their growing company. Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with US and Taiwan....

- Cambridge, MA

Exciting science being performed at this Pharmaceutical company. Looking to hire two Clinical Operations Leaders under the direction of the New Vice President Clinical.he Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical

- Waltham, MA

Medical director - new products (depending on experience – may be senior or executive position) Reporting to VP & Head of Medical Affairs NA Staff responsibility Potentially yes Employment type Full time Purpose As a member of the NA medical affairs team this person will provide state of the art medical expertise and medical leadership for New Products Essential Responsibilities Lead the NA medical strategy and provide medical leadership and contribution for New ProductsProvide subject....


The Global Regulatory Team Lead (GRTL) is a Director-level role which is part of the Global Regulatory Affairs (GRA) team based in the US. This position is in Irvine, CA and is part of the Global Strategy team. He/she is responsible for developing long- and short-term regulatory strategies that impact company’s business objectives. Specific responsibilities include: Global Regulatory Team Lead (GRTL) is responsible for developing global regulatory strategy for projects in his/her remit, which....


Pharmaceutical company hiring MSLs- Pain and Addiction - Opioids Opening for an MSL in Pain and Addiction : East Coast - CT, NY, NJ, PA (must be located in one of these states) The Medical Science Liaison (MSL) plays a crucial role in Medical Affairs, being part of an exclusive field-based team of medical scientific experts that partner with national, regional, and local key opinion leaders (KOLs). Thus, the MSL has significant responsibility and is expected to provide in-depth scientific,....


5 openings - must be located in one of the territories TERRITORIES:? IMMUNOLOGY/ONCOLOGY/RARE DISEASE New York Carolinas: Virginia, or North or South Carolina Great Lakes- Michigan or Ohio Chicago – Wisconsin or Illinois or Indiana Minneapolis: MN, Iowa, Nebraska, South Dakota or North Dakota DESCRIPTION:Develop and communicate in-depth clinical knowledge of Immunology and/or Oncology - Rare DiseasesEstablish relationships with opinion leaders, prominent academic and clinical investigators and


Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to company initiatives in assigned therapeutic areas. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized. Works closely with other personnel to ensure information, education, and research needs of healthcare....

- Any US State

Position Summary: The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol,....


Pharmaceutical company in need of Director or Senior Director to join the Medical Affairs team. The Medical Director will provide support and expertise in the area of psychiatry either Schizo or Addiction as there are two needs In this newly created and high profile role you will serve as the medical affairs strategic lead for our combination oral schizophrenia treatment that is currently in phase 3 clinical development. The Medical Director is expected to establish key medical strategies for....


Position Overview The Sr. Manager will represent Regulatory Affairs for pharmaceutical development projects and marketed products. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams. Main Areas of Responsibilities The Sr. Manager Regulatory Affairs will ensure technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted


We are currently recruiting for a NASH Medical Director, Medical Affairs within Global Medical Affairs (GMA) and the Chief Medical Office (CMO). Working under the leadership of the Global Therapeutic Area Head, this role develops a comprehensive medical strategy for several products in development to treat Non-Alcoholic Steatohepatitis (NASH). They will work closely with Clinical Development colleagues within Research & Development as well as colleagues within Global Evidence & Value....


Job Category: Research & Development The Senior Clinical Program Leader I3 (Inflammation, Immunology and/or Infectious Disease) is accountable for the operational strategy, planning and execution of the clinical development portfolio up to LIP for the designated Discovery and Translational Area (DTA).You provide the primary interface between the I3 DTA and pRED’s the Clinical Program Execution (CPEX) function in Clinical Operations, oversight for program and study management, line....


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....


The Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross-functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of studies keeping the....


The Director, Clinical Pharmacology acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team. The Associate Director/Director, Clinical Pharmacology is responsible for clinical pharmacology programs for assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. The Associate Director, Clinical Pharmacology will work in close collaboration with different....


Reporting to the Vice President, Drug Development-Generics, the Director, Project Management will use the global PDP (Product Development Process), allied systems & tools, to plan and manage/coordinate resources and activities related to product development and maintenance of business projects throughout Global R&D, and other company organizations. Responsibilities: Responsibilities:Champion and lead projects for new generic product development.Management of project team members from....


POSITION OBJECTIVE: The Senior Manager, Clinical Supply will be responsible for end-to-end drug supply planning activities across the Client clinical portfolio and for leading the clinical drug supply team. Responsibilities include forecasting supply requirements across the clinical portfolio and managing IP (Investigational Product) production and distribution process on time, with good quality, in compliance with Health Authority regulations/guidelines and Client SOPs. Collaborates and....


POSITION OBJECTIVE: Responsible for leading the CMC (Chemistry, Manufacturing and Controls) regulatory function, the Senior Manager, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing....


POSITION OBJECTIVE: The Director of Clinical Pharmacology and Drug Metabolism and Pharmacokinetics (DMPK) is responsible for overseeing internal and external activities associated with understanding the absorption, distribution, metabolism and excretion properties of multiple drug candidates in preclinical and clinical development. The person will play an active role on cross-functional program teams, this includes planning development strategies and interpreting data, as well as making....

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