- 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 ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the assigned trial… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational ... and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate corporate personnel are… 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 perspective; ... Represents clinical function at meetings with health authorities; Oversees management...management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. ... centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi ... development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be...senior leadership at DP0. Surface expert knowledge on safety biomarkers that might be used in preclinical and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this role, the incumbent will contribute to creation and improvement of Clinical Development processes. Job Description:Execute an overarching safety program ... experience in pharmaceutical industry.At least 2 years in Patient Safety .At least 2 years of experience in Clinical... Safety .At least 2 years of experience in Clinical Development.At least 2 years of Oncology experience. Competencies:… 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 ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific...clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility… 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 ... experience. The position is a core member of the Clinical Development management team responsible for developing and implementing, in alignment with corporate… 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
- Merck & Co. (Rahway, NJ)
- …Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in Process Research & Development ... external presentations.--Nature and Scope of Position:This role reports to the Senior Director of Chemical Biotechnologies within Enabling Technologies, Process… more
- Merck & Co. (North Wales, PA)
- …and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel are ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… 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
- 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 ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project ... indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at… more
- Eisai, Inc (NJ)
- …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 ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... for study level clinical sciences responsibilities, as well as clinical and safety monitoring under direct guidance of a physician (Global Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety , Data Management, and… more
