- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... direction for the clinical project management functions in a technology-driven, AI-focused biotech environment. This individual will be responsible for… 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 ... their management to share lessons learned and best practices across the Study Management Organization. The Director can serve as an SDL at early stages… more
- Insmed Incorporated (NJ)
- …in rare disease and/or orphan indications is preferred.Knowledgeable in all aspects of clinical operations, project management , the drug development process, ... vendor management , GCP, etc.Develops operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and… more
- Insmed Incorporated (NJ)
- …of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment!Extensive ... future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is...for both internal supply operations and external partnersServe as clinical supply representative on cross-functional project and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other ... rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the...MD, will lead the development and implementation of integrated project /product risk management strategies aimed at achieving… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP)… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** _Line management responsibilities:_ + Provides leadership, management , and/or mentorship to clinical study managers at various ... deliver on clinical trials are generated and considered **Quality** _Line management responsibilities:_ + Ensures team members are trained on and are adhering to… more
- CSL Behring (King Of Prussia, PA)
- …through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities. + Ability to evaluate, ... therapies that make a meaningful difference worldwide. The Associate Director Clinical Operations Lead is accountable for...Provide early input in CDP and study outline. + Project Management & CRO oversight: Lead cross-functional… more
- CSL Behring (Waltham, MA)
- …quality and reported within project timelines.? Project and Resource Management ? Work with Clinical Bioanalytics and Biomarker leadership team to execute ... a meaningful difference worldwide. Could you be our next Director Clinical Assay Strategy? The job is...external vendors, industry experts, and collaborators to ensure timely project progression and risk management .? Represent the… more
- CSL Behring (King Of Prussia, PA)
- … skills including risk mitigation + - Proficient in project management terminology and processes to drive clinical development program risk mitigation ... a meaningful difference worldwide. Could you be our next Director of Clinical Program, Immunoglobulins ? The...key study documents, including but not limited to the Clinical Development Plan (CDP), the Project Strategy… more
- CSL Behring (Waltham, MA)
- …within timelines to meet project requirements. Project and Resource Management Work with Clinical Bioanalytics and Biomarker leadership team to execute ... three days a week. You will report to the Director of Clinical Assay. You will be...external vendors, industry experts, and collaborators to ensure timely project progression and risk management . Represent the… more
- Organon & Co. (Plymouth Meeting, PA)
- …science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), project management and other partner groups as part of a ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be...(ADT) across the portfolio including drug candidates and lifecycle management (LCM) for mature products or be Clinical… more
- CSL Behring (Waltham, MA)
- …within timelines to meet project requirements. Project and Resource Management Work with Clinical Bioanalytics and Biomarker leadership team to execute ... three days a week. You will report to the Director of Clinical Assay. You will part...external vendors, industry experts, and collaborators to ensure timely project progression and risk management . Represent the… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. Could you be our next Senior Director , Global Clinical Program Lead, Cardiovascular? The job is in our ... Author" for: **key study documents, including but not limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator… more
- BeOne Medicines (Emeryville, CA)
- … clinical operations systems and associated reporting and visualization tools used in Clinical Operations + Proven project management , and/or IT ... **General Description:** The Director of Digital Clinical Operations Solutions...business and technical knowledge, and leadership behavior coaching to Clinical Operations Management Systems & Innovation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management Process for the respective business areas.Responsibilities:Leadership and Project Management :Lead the end-to-end quality execution across Medical ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and… more
- BeOne Medicines (Emeryville, CA)
- …operational levels + Other duties as assigned **Qualifications/Requirements:** + Strong project management skills, including ability to work independently, lead ... supply + Oversee and ensure feasibility, study start-up, site management , drug supply and other clinical studies'...multiple projects simultaneously and consistently meet or exceed project deadlines in a fast-paced environment + Ability to… more
- Organon & Co. (Jersey City, NJ)
- …The Non- Clinical Operations Lead will work closely with non- clinical project team representatives and non- clinical management to ensure the ... resources applied to outsourced activities/studies in conjunction with department management . + Engage and communicate effectively with non- clinical team… more
- Arvinas (New Haven, CT)
- … operations in the neurodegenerative/neuromuscular disease setting required + Excellent project management , communication and organizational skills required with ... partnering with clinical research physician + Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data management and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... strategic initiatives to standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will… more
