- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/ medical standards in accordance with ethical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Merck & Co. (Rahway, NJ)
- …of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses this understanding to ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program's ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...development plans and corporate objectives. Advanced understanding of clinical research and the clinical drug … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety, will be a product safety lead or part of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... in working with the team to execute the global clinical development plans of brensocatib for the...Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical … more
- Eisai, Inc (NJ)
- …a good understanding of other IT systems for contract management and clinical development .#LI-TS1Eisai Salary Transparency Language:The base salary range for the ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Merck & Co. (North Wales, PA)
- …proven track record of contribution to medical affairs strategiesExperience in country/region medical affairs or clinical development (in IBD or SLE or ... Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline &...countries and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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...SD works closely with the TA Leadership Team and Medical Director team to identify and execute… more
- Merck & Co. (Rahway, NJ)
- …drug development experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum of 5 years ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized… 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. ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities: Medical Monitoring Planning (MD Only): For large Phase 2 or ... medical content for protocol profile, protocol and amendments for small, uncomplicated clinical studies; Directs CRO medical monitor activities for Phase 2… more
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation ... your profile, we want to hear from you. The Medical Director , US Medical Affairs...planning and implementation of Phase IV clinical development programs for assigned products. Provide medical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical… more
- Eisai, Inc (Nutley, NJ)
- …and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for protocol ... we want to hear from you. Job Summary The Medical Director will provide medical ...development , planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs… more
