- Merck & Co. (North Wales, PA)
- …medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, ... design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific… 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...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... new medicines for patients. We recognize that improving human health starts here and that patients rely on us....make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional, holistic perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional ... interactions with CRO senior leadership as needed; Participates in creation of developmental...Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company...Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; ... regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans,… more
- Eisai, Inc (NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate ... teamsReviews data generated during study execution to formulate medical understanding of safety and efficacy resultsActs as Medical Monitor for one or more studies,… more
- Merck & Co. (North Wales, PA)
- …statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate corporate personnel ... Job DescriptionOur company is a global health care leader with a diversified portfolio of...and dedicated colleagues while developing and expanding your career.The Director (Sr. Principal Scientist) has primary responsibility for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patient safety , and regulatory compliance. Address recurring deviations and health authorities' observations as a priority. CAPA Management: Oversee the timely ... the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...lock, creating Clinical Study Report, and submission to the Health Authorities.Ensure that CS's within their group receive the… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will report to the ... Director , Engineering and will be a member of the...production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Process/Facility Engineer include the following:The process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... new medicines for patients. We recognize that improving human health starts here and that patients rely on us....Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project teams… more
- Merck & Co. (Rahway, NJ)
- …DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety , high quality data and compliance with company requirements and regulations ... operations to achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in collaboration with the Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, ... new medicines for patients. We recognize that improving human health starts here and that patients rely on us....Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned… more
- Merck & Co. (North Wales, PA)
- …statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel ... Job DescriptionOur company is a global health care leader with a diversified portfolio of...and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist) has primary responsibility for the planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stage) within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...lock, creating Clinical Study Report, and submission to the Health Authorities.- Ensure that CS's within their group receive… more
