- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and programmanagement,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... at the program level through the operational resources assigned to their program . May on occasion represent Global Clinical Operations on the Strategy and… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GDIM to drive technology-enabled process improvements. Build strong relationships with clinical development , clinical sciences, regulatory, biostats, data ... strong collaboration. Partner with other functional excellence colleagues, such as clinical development , to ensure harmonization. Responsible for maintaining… more
- Eisai, Inc (Nutley, NJ)
- …members.Requirements Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development or ... and assess long-term resource, technology, and skill needs for respective program (s) within clinical quality area.Anticipate immediate and long-term risks… more
- Organon & Co. (Jersey City, NJ)
- …Translational Medicine and Early Development (TMED) Department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study ... literature and regulatory guidance and support the approved early development plans. The Clinical Pharmacology Lead...optimizes dose selection, facilitates the efficiency of the overall program development plans and enables fastest to… more
- Parexel (Trenton, NJ)
- **PXL is seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the ... related to clinical study samples, data, kits, and logistics. - Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health… more
- Insmed Incorporated (NJ)
- …600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development .Demonstrated success in QA oversight of CDMOs, CROs, and ... Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s). Lead establishment of test methodologies, including method development … more
- Insmed Incorporated (NJ)
- …data.Supports research and development programs as requested by Insmed R&D, Clinical Development & Operations, and Medical Affairs Departments.Partners with ... supply to pipeline and clinical trial activities to further clinical development .Builds strategic and working relationships with external HCPs,… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a… more
- Merck & Co. (Rahway, NJ)
- …Skills: Academic Quality Improvement Program (AQIP), Academic Quality Improvement Program (AQIP), Adaptability, Budget Development , Clinical Supply Chain ... with clear roles & responsibilities, governance forums, KPIs, and service delivery expectations. Lead development and adoption of data policies, standards, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication of emerging data (internal or competitive), such as congress updates and development program highlights; and budget and forecast accuracy- In a ... the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program … more
- Insmed Incorporated (NJ)
- …stakeholders across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. ... This is a global role.What You'll Do: Lead development of HEOR strategy for gene...of HEOR strategy for gene therapy products from early clinical development through product launch and life… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pathology, to support design and implementation of translational pathology plans.- Lead development of the translational pathology strategic direction and ... statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation ... information requests associated with executed capacity studies, as needed.Coordinates the development of operational models to meet clinical and commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.- Provides medical leadership in interactions with key ... of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program… more
- Insmed Incorporated (NJ)
- …specialists, and community physicians.Partner with Medical Affairs to ensure scientific and clinical insights inform HCP strategies. Lead development and ... including positioning, messaging, and go-to-market frameworks tailored to HCPs treating fibrosing ILDs. Lead campaign development to engage pulmonologists, ILD… more
