- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...and translational work for the purpose of generating the early clinical development plan and Investigational New… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Merck & Co. (Rahway, NJ)
- …Monitoring Visits Reports and escalates performance issues and training-needs to CRA ( Clinical Research Associate ) manager and/or functional vendor and internal ... in assigned studies.Escalates as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... early -stage programs, in order to proactively perform safety surveillance...and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... Data) for data submissions and relative processes. Working knowledge of early and late-stage submissions per local/regulatory requirements, demonstrated ability to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and scientific direction is provided on promotional strategies and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trials preferred- Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred- Solid ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...through early and/or late phase development. The Associate Director reports to the Director… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ... early and/or late phase development. Reports to the Director , Clinical Sciences Hematology, Clinical ...programs. May be responsible to manage one or more clinical scientists. As an Associate Director… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …_This role has a 3-day onsite minimum requirement in Armonk, NY._ **As an Associate Director in Precision Medicine, a typical day may include the following:** ... clinical biomarker strategies to support key programs in early and late stage drug development. Clinical ...in early and late stage drug development. Clinical technologies applied include biomarker assays, pharmacogenetic assessments, as… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Clinical Imaging will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical ... of study's imaging components and endpoints. + Serve as Study Director for clinical trials focused on qualification and utilization of novel imaging biomarkers.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. **Summary** The Associate Director , Clinical Data Standards, is responsible for ... Data) for data submissions and relative processes. Working knowledge of early and late-stage submissions per local/regulatory requirements, demonstrated ability to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... early -stage programs, in order to proactively perform safety surveillance...and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Merck (Rahway, NJ)
- **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...and translational work for the purpose of generating the early clinical development plan and Investigational New… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , Quantitative Systems Pharmacology (QSP) will work within ... to aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial design + Interact with, and possibly lead,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and Quality of Care (PAQ) ... position is at our Headquarters in Foster City, CA or Parsippany, NJ. The Associate Director , PAQ- Virology will have responsibility for leading the development… more
