- 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: ... meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase... related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of a physician (Global Clinical Leader or Physician Scientist). The clinical science lead will also participate in the creation and management of new ... depending on the scope and size of the asset program . This Clinical Science (CS) lead...incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …governance bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to ... mitigation plans.Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader . Review and approve… more
- 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
- Merck & Co. (Rahway, NJ)
- …planning and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical ... focuses on the planning, execution and close out of clinical trials within a program .- Clinical ...training and operational project assignments under the direction of Lead Clinical Scientist and Lead … more
- Merck & Co. (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager ... opportunity to gain professional experience in a 12-week fellowship program . Who we are We are known as Merck...Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Insmed Incorporated (Bridgewater, NJ)
- …an exciting time of growth for Insmed, we are in search of a passionate leader for the role of Biostatistical Head of Medical Affairs. This position, reporting to ... the VP of Biometrics presents a unique opportunity to establish and lead a team of statisticians to collaborate closely with the Medical Affairs organization to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Investigators. Essential Functions Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both ... Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory… more
- Merck & Co. (Rahway, NJ)
- …the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical...in one of the world's most research-intensive biopharmaceutical companies. Senior Specialists in QP2-I/O-will work in collaborative teams with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place 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 ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Insmed Incorporated (Bridgewater, NJ)
- …will possess a deep understanding of the pharmaceutical development process from pre- clinical development through life-cycle management and be willing to engage with ... techniques in support of preclinical stage small molecule research projects. Lead activities related to analytical testing and method qualification, including… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... senior management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy. Author nonclinical sections in regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The ... research areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior , cross-functional leader in Daiichi Sankyo's… more
- Lundbeck (Miami, FL)
- …major airport. Territory consists of Florida, Georgia and Puerto RicoSUMMARY: The Senior MSL, Neurology will apply advanced field based medical and scientific ... medical strategies for Lundbeck compounds. Maximizes and leverages key opinion leader (KOL) relationships by identifying mutually beneficial opportunities that meet… more
- Lundbeck (Bothell, WA)
- …Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the successful execution of brand/therapy ... and monitors adherence to administrative policies and procedures. The HCP experience lead has a team reporting to them potentially inclusive of hcp experience… more
