- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Merck & Co. (Rahway, NJ)
- …availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require project /initiative leadership, ... position will be responsible for providing engineering leadership and cross-functional project support at the Rahway, NJ FLEx (Formulation, Laboratory &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...and oversee completion of clinical trial protocols. Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Merck & Co. (Rahway, NJ)
- …advancements into impactful medicines that help people globally. Reporting to the Associate Vice President, Global Market Access, Global Pharma, the Executive ... Director , Global Market Access, PAH and Rare Disease will...team including marketing and Product Development Teams (PDTs), (ex. clinical , OR and medical affairs), regional and country teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. ... Develops and maintains a working relationship with the internal project team(s) and team leader(s) or US based Global...to the Global Team Lead (GTL) and GPT (Global Project Team) for the control and reporting of approved… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for patients who are likely to benefit from our therapeutics.Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Associate Director , Project Management is an integral member of ... Drug Integrated Development Strategy. As a senior, highly experienced team member, the Associate Director , Project Management is responsible for monitoring… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. **Summary** The Associate Director will be responsible for developing and implementing ... Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Merck (Rahway, NJ)
- …in the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Bristol Myers Squibb (Summit, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... are supported. The CP&P team interacts with discovery and translational scientists, project leadership, early and late clinical development teams and commercial… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy: ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...oversee completion of clinical trial protocols.… more
- Merck (Rahway, NJ)
- **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …relevant experience in academic clinical trials (10 years post fellowship clinical and research experience, associate or full professorship preferred). We ... physician scientist with significant pharmaceutical/biotechnology sector and/or exceptional academic clinical trials' experience. With oversight from supervisor, works with… more
