- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage...clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program...start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary ... team. Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials ; Reviews regulatory documents from cross functional, holistic ... and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project; Attends EOP2 meeting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… 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) ... is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical Study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work across different functional teams to support the design and execution of clinical trials , the drafting of medical/ scientific documents, safety monitoring, ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific...abstracts and manuscripts Provide leadership in the execution of clinical trials Ensure compliance with SOPs, ICH,… more
- Merck & Co. (North Wales, PA)
- …Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have ... execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Times, Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog ... Minimum 7 years' experience in life sciences, pharma with Clinical Trials Operational Data, Clinical ...KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIt is critical that, for all company-sponsored clinical trials , patient safety, high quality data and compliance with company requirements and ... Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives....achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in… more
- Tris Pharma (Monmouth Junction, NJ)
- …program development (ie, substance use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry ... expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and...company pain programDirects and oversees analysis and interpretation of clinical trial data and clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and ... milestones in launch planningMedical leadership input for cross functional partners including clinical , operations, HEOR and commercial to ensure that there is a… 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 ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other members of the Medical Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director of Medical Writing. A key ... clinical /regulatory documents Authors, reviews and/or edits documents to support clinical trials and regulatory submissions, which may include: Clinical… 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...for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing:… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be...Medical Affairs role. Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area.… more
- Eisai, Inc (NJ)
- … provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... in-house Medical Affairs role; MD preferredClinical research experience, including conducting clinical trials in the Phase IIIb-IV area.Expertise in… more
