- Catalent (New York, NY)
- …pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... Account Director , Biologics Drug Substance Catalent Biologics is a...remote, field-based role. Travel is required to support business development activities.The Role Overall responsibility to manage the business… more
- Merck & Co. (Rahway, NJ)
- …pre- clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.Providing ... involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the entire cycle of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as with early -stage compounds required- Excellent understanding of the clinical development and life cycle of oncology medicines required- Strong ... functions including but not limited to Commercial, Marketing, Medical, & Clinical Development ,ResponsibilitiesGlobal Market Access Strategy- Lead the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategyResponsibilities - Accountable for developing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Merck & Co. (Rahway, NJ)
- …recommendations regarding commercialization strategies, portfolio prioritization and sourcing, clinical development /research strategies, and Business ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Merck & Co. (Rahway, NJ)
- …(Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT),-and Labeling ... drug development experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum of 5 years… more
- Merck & Co. (Rahway, NJ)
- …alignment with the goals, purpose and-mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO Global Clinical Trial ... in assigned studies.Escalates as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager and… more
- Insmed Incorporated (Bridgewater, NJ)
- …the company in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP ... 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)
- …responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene ... teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds. Performs collaborative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... and Pharmacovigilance (CSPV) must be embedded in R&D as early as possible. This led us to create the...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play ... Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch- Leads CDx Partner evaluation and selection,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … 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
- Catalent (New York, NY)
- …pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... a part of the Global Nutritional & Beauty Business Development Team reporting to the Regional Director ...Business Development Team reporting to the Regional Director Beauty Softgels North America, and responsible for managing… more
- Insmed Incorporated (Bridgewater, NJ)
- …Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic cross-functional ... interaction between lead optimization research and early CMC development .Responsible for the management of API/Intermediate/RSM manufacturing operations at… 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 ... , nonclinical and biomarkers studies. This translational role resides within the Clinical Development organization, works closely with colleagues in other… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- ** Director , Biostatistics Early Clinical Development Gene Therapy** The Director of Biostatistics provides leadership and guidance as the statistical ... with Strategic Project Teams on clinical and regulatory strategies for clinical development , and to represent statistical issues in regulatory agency… more
- Bristol Myers Squibb (Summit, NJ)
- …lead the clinical development teams. Extensive experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is ... . The Senior Director will be the clinical lead to progress multiple early ...and/or neuropsychiatry is a plus. **Functional Area Description** The Early Clinical Development function is… more
