- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the ...CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between ... CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for specific categories under ... Years Deep experience in pharma procurement & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead ... deliverables from vendors as well as work by in-house statistical programmers.- CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Job Summary: The Director , Diagnostic Sciences will be responsible for end-to-end process for CDx ... or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a (Sr.) Director , Research as part of the US R&D team based in Piscataway, NJ. Role ... collaborate across functional teams internally and effectively manage external CRO .English, ability to speak Chinese (Mandarin) is a plus.#LI-RT1#LI-HybridLegend… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with stakeholders to ensure a compliant ready state of operation.Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and CAPAs followed up ... and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. Qualifications: Successful candidates will be able to meet ... the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)Bachelor's Degree preferably in a scientific discipline required.Advanced degree (eg, Masters, Pharm.D., Ph.D., MD, JD)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …goals of the external collaborations. Establish and maintain effective communication between CRO / vendors / ARO. With the Companion Diagnostics Lead, develop a ... companion diagnostic plan for the program across all relevant indications as needed. Leverage disease area strategy or cross-asset strategy by working together with Translational Strategy Leads on other projects, internal and external experts. Qualifications:… more
- Merck & Co. (Rahway, NJ)
- …peptides and CRISPR guides. Knowledge and experience working with CRO 's, externalizing/internalizing projects/assays/reagents to solve for Capacity and Capabilities. ... Experience managing/developing scientists and a track record of successfully leading projects/teams to clear outcomes. Passion for fostering a diverse and inclusive culture and contributing to the growth and success of colleagues. Strong external reputation as… more
- Grand Canyon University (Phoenix, AZ)
- Arena Control Room Operator job in...lighting, HVAC and fire alarm under the direction of Director of Operations. + Check radios in and out to ... + Graduate Assistant Opportunities + Return to GCU Home (https://www.gcu.edu/) Arena Control Room Operator Click Here to Apply Online Job Description Grand… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Director , Preclinical CRO Strategic Outsourcing in our Cambridge office. At Takeda, we are ... operational excellence and portfolio progression for the Takeda Research pipeline. The Director of Preclinical CRO Management will provide strategic oversight… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking a highly motivated **Associate Director ** to join to our Bioanalytical Sciences team. You will be responsible for coordination of assay ... for external bioanalytical assay strategy and data interpretation. As an **Associate Director ** , a typical day may include the following: + Providing scientific… more
- Norstella (Columbus, OH)
- Account Director , CRO Partnership Company: Citeline Location: Remote, United States Date Posted: Sep 9, 2024 Employment Type: Full Time Job ID: R-386 ... from pipeline to patient. **The Role:** As an Account Director , you will grow and maintain an existing client...and maintain an existing client base of top Clinical CRO accounts through renewal and expansion of long-term partnerships.… more
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