- Merck & Co. (Rahway, NJ)
- …of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses this understanding to ... inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables...bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of… more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program ...+ 6 years OR PhD/PharmD + 2 years Pharmaceutical and/or- clinical drug development experience. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategyResponsibilities - Accountable for developing the… 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 ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… 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 ... development plans and corporate objectives. Advanced understanding of clinical research and the clinical drug ...Advanced understanding of clinical research and the clinical drug development process Advanced understanding of… 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 ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… 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 ... Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...analytic support to the field team, and assists the Program Development and Training function for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.Provides medical leadership in interactions with key ... areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... 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,… 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 ... 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)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... Representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...analytic support to the field team, and assists the Program Development and Training function for the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development Division (R&D). The Project Managers in GPAM are core members of ... the CMC Integrated Project Management organization (CIPM) serves on the Development and Commercialization Teams (DCTs) responsible for developing and executing an… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with ... strategies for that therapeutic area.She/He will strategize and execute Phase IV clinical development programs for assigned products.Design and review IIS… more
