- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase...life cycle is optimized across multiple programsThe CS group lead will also contribute to the program … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study(ies);… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on regular basis ... or escalate study issues /risk mitigations to the Operations Program Lead and study team leader...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Merck & Co. (North Wales, PA)
- …execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead , you will collaborate with global, cross- functional team-members including ... trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is integral to R&D and partners with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... veterans and people with disabilities. SummaryReporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is an integral part of R&D and… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the...including time in role such as a Global Project Leader at Sr. Director level or equivalent… more
- Merck & Co. (North Wales, PA)
- …in organization development and building a new team.Reporting to the Executive Director of CMC Integrated Project Management, the core responsibility of this ... to manage the Vaccines portfolio of products within CIPM. In addition, the Director will be expected to mentor/coach Project Managers (PMs) (through direct and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs projects within a specific compound or indication.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... these objectives. This position will report to the Sr. Director , Group Leader , GPM&L. Responsibilities Project Responsibilities:...Establishes and maintains a high performing team.Partners with the Clinical Team Leader to ensure a high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead .Responsibilities:Medical Monitoring Planning (MD Only): For large Phase 2 ... surveillance and safety summaries, such as Section 2.7.3 of eCTD.Study Strategy: Clinical Study Leader (CSL) or Major Scientific/Medical Contributor; For large… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on regular basis ... or escalate study issues /risk mitigations to the Operations Program Lead and study team leader... Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development,...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
