- Daiichi Sankyo, Inc. (Bernards, NJ)
- …universe for GMP relevant activities involving but not limited to supplier qualification program , CMC audit, clinical /IMP vendor audits and overall GMP vendor ... deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or… more
- AbbVie (Madison, NJ)
- …bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and ... role is key to ensuring successful delivery against the program - and study-level accountabilities assigned to Data and Statistical...assigned studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team… more
- Rady Children's Hospital San Diego (San Diego, CA)
- …the Manager, DS Inpatient & Medical Therapy Services, the Supervisor, DS Medical Therapy Services provides clinical supervision for Occupational Therapists, ... with demonstrated competency and knowledge of pediatric feeding and swallowing clinical practices and related business operations.** JOB SUMMARY: Under the direct… more
- Amazon (Palo Alto, CA)
- …you will be a strategic advisor to various S-teams and provide practical, clinical advice to business owners and communicate recommendations to leadership and, as ... feature requests, recommend alternative technical and business approaches, and lead engineering efforts to meet aggressive timelines with optimal solutions.… more
- Lilly (Indianapolis, IN)
- …focused on bringing new protein therapeutics to market by producing bulk drug substance ( DS ) for clinical trials, along with the associated technical data and ... team within BR&D is responsible for the manufacture of DS to support clinical trials within the...you will provide oversight of downstream processes for Bulk DS production and lead initiatives that enhance… more
- AbbVie (South San Francisco, CA)
- …influences all levels of management and cross-functional team members to achieve program objectives. Represents DS in cross-functional forums and, if assigned, ... abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. Coordinates and participates as the DS study owner in… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …follow-up; physical disabilities such as cerebral palsy; genetic issues such as Down Syndrome ; sleep and feeding disorders; and, educational problems including ... students; and participate in other scholarly endeavors that will lead to academic promotion. The successful applicant will assist...of a multi-disciplinary team and to develop a specific clinical or educational focus within the larger program… more
- Lilly (Indianapolis, IN)
- …excellence and innovation to accelerate manufacturing advancements. The team translates API/ DS process knowledge into clinical supply readiness, oversees ... Technology Transfer** + Provide strategic leadership and oversight for clinical API or DS technology transfer activities...are continuously aligned with the evolving demands of the clinical portfolio. + Define and lead Foundry's… more
- Merck (West Point, PA)
- …Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance ( DS ) and Drug Product Intermediates ... stages. We are part of the Process R&D organization, which enables modality-agnostic DS /DPI process development and clinical manufacturing for all of our… more
- Providence (Irvine, CA)
- …maximized in service to triple aim + Responsible for coordinating with system Clinical Program Services leadership and Supply Chain Shared Services leadership in ... across the organization through expert-to-expert collaborative initiatives, in conjunction with Clinical Program Services + Participates at the executive level… more
- J&J Family of Companies (Spring House, PA)
- …and digital diagnostics using AI/ML and other appropriate methods. This role will lead clinical -stage therapies such as Darzalex, Tecvayli and Talvey. Additional ... early and late stage pipeline assets. This person will lead a team aimed at supporting the Clinical...is eligible to participate in the Company's long-term incentive program . Employees are eligible for the following time off… more
- J&J Family of Companies (Titusville, NJ)
- …R&D data ecosystem. Working closely with Global Development Data Science teams, Clinical Development, Operations, and Regulatory stakeholders, as well as the broader ... compliance outcomes. **Key Responsibilities** **:** **Data Product Strategy & Execution** + Lead a team to define and deliver data products addressing critical… more
- J&J Family of Companies (Spring House, PA)
- …and presenting to and negotiating with leadership teams on development plans or program -related issues. + Participate in and may lead cross-functional teams for ... successfully meet these objectives, this individual will work closely with individual clinical project teams as well as functional area partners in Discovery, Late… more
- Takeda Pharmaceuticals (Boston, MA)
- …process development (Upstream and downstream), process technology transfer and support of clinical manufacturing of drug substance ( DS ) using mammalian cell or ... ADCs, novel biologics), ensuring robust, scalable, and cost-effective processes. + ** Lead a high-performing, diverse global organization** , including multiple sites… more
- Merck (West Point, PA)
- …reliable system operations. The new EBR system will be deployed to support Clinical Bulk Manufacturing operations. **Key Responsibilities:** + Lead the design, ... data-driven operations across GMP manufacturing. Based in the Bioprocess and Clinical Manufacturing Technology Department within the Biologics Pilot Plant (BPP) in… more
- J&J Family of Companies (Spring House, PA)
- …across our biologics discovery platform. We are on the lookout for key talent to lead the ISB team in the application of these models across the Johnson & Johnson ... innovative new medicines to patients. As a Director within our team, you will lead a core group of computational antibody design scientists. You will be responsible… more
- J&J Family of Companies (Spring House, PA)
- …humanity. Learn more at https://www.jnj.com **Job Function:** Discovery & Pre- Clinical / Clinical Development **Job Sub** **Function:** Nonclinical Safety **Job ... within the Preclinical Sciences and Translational Safety (PSTS) organization, will lead the application of data science and machine learning (ML) methodologies… more
- J&J Family of Companies (Titusville, NJ)
- …development of AI applications in areas such as discovery, biomarkers, and clinical endpoints. This leader will engage across the enterprise, partnering with DSDH ... supervise the productization of AI models into applications deployed within R&D or clinical trials for discovery, biomarkers, and clinical endpoints. + Oversee… more
- CVS Health (Trenton, NJ)
- …facing initiatives. This role requires a strong understanding of product management, clinical data, data science, and business strategy. The ideal candidate is able ... of TCE portfolio to stakeholders across the organization. + Lead storytelling for impact, learnings, and go forward strategy...campaign results, and portfolio level strategy + Work with DS to improve existing campaigns in the portfolio and… more
- AbbVie (Worcester, MA)
- …to develop and implement untested solutions. + Ability to provide technical program leadership, including external vendor management and lead cross-functional ... and deliver innovative solutions enabling the advancement of AbbVie's Clinical and Commercial Drug Substance manufacturing processes. Responsibilities: + Support… more