- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Oversees early -stage trials, such as global clinical development program for multiple product candidates with one or more ... indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development , clinical science, clinical quality ... rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk...and their line management to ensure prevention of issues, early identification of issues, and provide expert advice on… 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)
- …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)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development… 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... will work closely with cross-functional project teams, including Clinical Development , Clinical Operations, Biometrics,... development and regulatory requirements of a clinical program. The Director will provide high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... About the Department Our East Coast Global Development Hub brings together the best minds in...internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East Coast Development...decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical … more
