- 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
- 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
- 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)
- …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
- 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
- Merck & Co. (North Wales, PA)
- …and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in ensuring ... with talented and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the… 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
- 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
- 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
- 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
- AbbVie (South San Francisco, CA)
- …and LinkedIn. Job Description In collaboration with a therapeutic area, the Scientific Director , Clinical Science will lead the design, conduct, analysis, and ... for late-stage assets. * May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs. May… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary This position supports early phase oncology development and leads complex studies in study design, ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … 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
- J&J Family of Companies (Cambridge, MA)
- Associate Director , Translational Clinical Medical Lead Translational Science & Medicine- Immunology - 2406188164W **Description** At Johnson & Johnson, we ... https://www.jnj.com/ . Johnson & Johnson is recruiting for an Associate Director , Translational Clinical Medical...pharmacovigilance and/or drug safety officer in a CRO, pharma/biotech. Early Clinical Development and Clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- 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 (Cambridge, MA)
- We are seeking an ** Associate Director - Clinical Trial Management** to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. You ... identification of project risks and contingency planning. **As an Associate Director - Clinical Trial Management,...might include:** + Leading day to day operations of clinical early phase oncology cell therapy studies,… more
- GRAIL (Menlo Park, CA)
- …pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director will work cross-functionally to manage Grail's Clinical Quality ... GRAIL is a healthcare company whose mission is to detect cancer early , when it can be cured. GRAIL is focused on alleviating the global burden of cancer by… more
- Lilly (IN)
- …City, South San Francisco, Stamford, CT, and Madrid, Spain. **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for ... around the world. **About Loxo@Lilly:** Loxo@Lilly (L@L) conducts discovery research, clinical development, and regulatory affairs for oncology, with the goal of… 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
