- Insmed Incorporated (San Diego, CA)
- …You'll Do: Participate in cross functional teams to develop and implement clinical studies within clinical program (s). Responsibilities include but ... Clinical Development, you will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or… more
- Eisai, Inc (Nutley, NJ)
- …and monitor study data.Implements strategies to identify, monitor and resolve clinical program /trial issues.Interprets study data and develops integrated ... of Clinical Protocols to meet CDP objectives.Serves as Study Director/ Clinical Pharmacology Lead and drives the execution of the study from protocol concept… more
- Formation Bio (New York, NY)
- …to high standards of quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies. Step in as the ... for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development, Regulatory, Program Management, etc.) to shape and refine… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …closely with internal functions such as Pharmacology, CMC, Regulatory Affairs, Clinical , and Program Management.Maintain up-to-date knowledge of evolving ... myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role OverviewWe are… more
- Insmed Incorporated (NJ)
- …Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP ... change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive… more
- Insmed Incorporated (NJ)
- … Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and supervise the clinical ... trials, through to full development. You'll also: Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely with… more
- Merck & Co. (Rahway, NJ)
- … clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for the device development strategy for ... IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production with respect to device… more
- Insmed Incorporated (NJ)
- … staff (CRAs, and CTAs) by demonstrating leadership competencies.Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead , and ... other, and for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV… more
- Insmed Incorporated (NJ)
- …Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and… 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 ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject... level through the operational resources assigned to their program . May on occasion represent Global Clinical … more
- Genmab (NJ)
- …RoleGenmab is currently seeking a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate, high profile, high impact ... a highly dynamic and collaborative setting.The Director, HEOL Team Lead is part of the US Field Medical Affairs...Team to ensure adequate and appropriate communication of Genmab's clinical and economic value messages. The Director, HEOL Team… more
- Insmed Incorporated (NJ)
- …on a leading program manager role for major programs. As a leader , the Executive Director will work with multiple partners across Insmed to ensure consistent ... and accountable for creating a best-in-class team to plan, integrate and lead activities associated with moving Insmed's late-stage pipeline through clinical … more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functionally with multiple functions and groups throughout the US organization, Clinical Development, Research & Early Development, other affiliates, and the Global ... the lives of more patients than ever before. The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …across all functions and sites.Support the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support Legend's ... will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and… more
- Merck & Co. (Boston, MA)
- …the Neuroscience Therapeutic Area and strategy, bridging Discovery Research through Late-Stage Clinical Development. The Therapeutic Area (TA) Lead will provide ... clinical space, determining and implementing the initial clinical strategy through proof-of-concept/pharmacology/principle and driving the transition from early… 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) ... (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / Support clinical supplies production with respect to device… more
- Merck & Co. (North Wales, PA)
- … is innovative, collaborative, strategic, compassionate, and can lead directly and indirectly through influence.Responsibilities and Primary ActivitiesDevelops ... Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic patient… more
- Merck & Co. (North Wales, PA)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... for the benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides… more
