- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our ... to streamline workflows and accelerate decision-making. Drive cross-functional planning, risk management, and clear action tracking. Flex Capacity (Post-Acquisition… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in ... NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities… more
- Formation Bio (New York, NY)
- …more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role ... with assessment of potential new assets from a technical and financial risk standpoint. About YouRequired Qualifications MS or PhD in pharmaceutical sciences,… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they escalate.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation.Operational Oversight and Reporting: Oversee the ... management of QA shared resources, ensuring accuracy and timely updates of information related to ongoing activities. Produce and deliver accurate reports and documentation related to Global QA activities in collaboration with relevant stakeholders.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... risk management activities completion for vendors and to periodically review vendor performance in order to ensure the management in accordance with local procedures… more
- Merck & Co. (Boston, MA)
- …development, strategy execution and value realization, enterprise strategic planning, risk management, and strategic venture investments in healthcare as part ... Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management, Strategic Thinking, Strategy Development, Strategy Execution, Teamwork… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tools and processesWork within existing Company policies and SOPs to manage risk and develop mitigation approachesLead and/or contribute to the development of ... policies and SOPs governing DigitalDrive the evolution of the Medical Analytics and IntelligenceProvide strategic direction and oversight for the Medical Analytics and Intelligence teamEnsure alignment of analytics initiatives with the Medical Affairs digital… more
- Insmed Incorporated (NJ)
- …assess regulatory risks associated with product development and define risk -mitigation strategiesProvide regulatory guidance across functions throughout the R&D ... process and advise on the US IND and global CTA submission strategiesDirect the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and gathering of quality ... metrics for Legend's Quality Management Review (QMR).Support management of the Quality Management Review (QMR) program.Support continuous improvement efforts through the monitoring of audit metrics.Assist with the development, maintenance and execution of the… more
