283 associate director clinical supply project manager jobs found

Legend Biotech USA Legend Biotech is seeking an Strategic Sourcing, Senior Manager/Associate Directo r as part of the Technical Development team based in Somerset, NJ. Role Overview Legend Biotech USA, Inc. is seeking a motivated and experienced Strategic Sourcing Senior Manager to join its Technical Development team to deliver a pipeline of cell related innovative therapies. The ideal candidate will possess a scientific background and expertise in sourcing and procurement from external CDMOs to establish and lead a team that supports an expanding supply chain for clinical-stage external materials. Reporting to the Senior Director of Materials Science, this role will enhance and manage processes for sourcing both non-GMP and GMP materials essential to cell and gene therapy programs. The selected candidate will collaborate with technical experts to develop and manufacture clinical-stage starting materials, drug substances, and products required for Legend's...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham Posted Date: Oct 16 2024 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. As a Regulatory Affairs Management Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham Posted Date: Oct 16 2024 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. As a Regulatory Affairs Management Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and...

Massachusetts Bay Transportation Authority (MBTA) At the MBTA, we envision a thriving region enabled by a best-in-class transit system. Our mission is to serve the public by providing safe, reliable, and accessible transportation. MBTA’s core values are built around safety, service, equity, and sustainability and each employee that works for the MBTA performs their roles based on our vision, mission, and values. This includes attendance, participation, and contribution in local safety committee meetings as needed. Job Summary The Manager of IT Systems will manage the activities and personnel of the MBTA Server Team to ensure our users receive the highest level of IT support and services. This position is responsible for the design and maintenance of Microsoft Windows and HP UX /Linux server environments and enterprise-wide storage devices including high availability, data replication, disaster recovery, fail over and redundancy wherever possible. Performs regular...

GSK Are you energized by leadership, education, and development of partnerships with key External Experts and Professional Bodies? If so, this Field Based Medical Science Liaison role could be an ideal opportunity to explore. Job Territory: This is a field-based position covering primarily Colorado and Utah with modest engagement in Wyoming and Montana. Must reside within the Denver metro area and be accessible to an airport. As a Field Based Medical Science Liaison, you will be responsible for execution of the external engagement strategy aligned to the therapeutic portfolio, as well as implementation of the external engagement plan aligned to Therapy area strategies, driving a consistent approach to carrying out engagement activities in the field. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Engage in bi-directional Scientific Exchange...

CareFirst BlueCross BlueShield Resp & Qualifications PURPOSE: The Senior Business Consultant provides expertise in tailored, strategic, and critical work to help design, launch, and execute programs that support initiatives in the changing healthcare industry ESSENTIAL FUNCTIONS: Provide subject matter expertise in a particular area (including but not limited to one of the following: project management, finance and budget, human resources, data and metrics, information technology, etc.) that contributes to the effective accomplishment of initiatives tasks and goals. Collaborate on the business strategy, thesis, programs and the identification of strategic opportunities. Proactively build and lead cross-functional teams and projects between division, and internal and external stakeholders to deliver value to supported team. Proactively identify ways, means, and platforms to build synergy and mutually reinforcing workstreams to accomplish tasks more effectively...

Apex Systems, Inc. Job#: 2067836 Job Description: Head of Immunology & Inflammation 2067836 Location: Waltham, MA (Hybrid) Therapeutic Area: Auto-Immune Job Overview: The role involves strategizing and managing the clinical development of autoimmune drug candidates, necessitating extensive experience in clinical research and a collaborative, fast-paced environment. Primary Job Responsibilities: Lead and take ownership of early stage (phase 1-2) clinical trial design Write clinical trial synopsis, protocols, and associated documents Collaborate with the clinical operations team to select investigators and provide project-related education to study site personnel and staff Plan and oversee all clinical aspects of specific programs Lead clinical study teams, monitor trials, and review and analyze safety and efficacy data Prepare clinical reports and publications, and present at scientific and medical advisory board meetings and regulatory meetings...

Apex Systems, Inc. Job#: 2067672 Job Description: VP Clinical Development 2067672 Location: Waltham, MA (Hybrid) Focus: Small Molecule Job Overview: In this role, you will be responsible for leading the strategy and execution of clinical development programs for RNA splicing therapies, closely managing and coordinating related activities, and thriving within a dynamic, fast-paced, and collaborative environment. Primary Job Responsibilities: Take charge of early-stage clinical trial design for innovative RNA-modifying drugs, from Phase 1 to 2. Write synopses and protocols for clinical trials, as well as related documentation. Work with the clinical operations team to choose investigators, oversee their training, and ensure collaboration across study sites. Oversee all clinical activities for specific programs and lead the associated study teams. Monitor trials, manage data, and communicate findings; prepare clinical reports and represent the company at...

BAE Systems Job Description BAE Systems is hiring an Indirect Procurement Manager to support Indirect Procurement. This role will support the Combat Mission Systems (CMS) Business Area that includes annual revenues in the billions and material spend in the hundreds of millions across a diverse set of suppliers and commodities / categories. The role will lead and direct the daily activities of the procurement process for Indirect products and services and capital items which support the business infrastructure. This position is accountable for the quality, compliance, schedule, and financial and technical performance of the internal team and the associated supply base. The Indirect Procurement Manager may be remote. Responsibilities: Lead and manage a team of Procurement professionals at various experience levels that are geographically dispersed to meet and/or exceed business requirements, goals, and objectives Lead all strategic and tactical Supply Chain activities within...

UNC Health Description Looking for an energetic, positive person to join the UNC Surgical Services Business Office to serve as a Materials Analyst. Maintain large consignment inventory of specialized implants. Focus on tissue management and reconciliations. Work closely with surgeons offices for patient specific implants and keep weekly log. Will also be involved in monthly Surgical Value Analysis Committee (SVAC). This position requires excellent customer service & communication skills. This job will require a knowledge of the OR and surgical implants, multitasking, initiative & ability to adapt to changes in work environment & service needs. Performs other related duties as may be assigned by the Director or Business Manager. This is a 40 hour a week, Monday - Friday 8:00a - 4:30p. Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary: The...

Merck Job Description Are you a motivated and experienced Engineering Maintenance & Utilities Specialist looking for a challenging and rewarding opportunity? Do you have a passion for driving excellence? We're seeking a growth and improvement-minded Specialist to join our team and support internal and external manufacturing operations. This position would serve Building 50 and Building 51 and any other building that is under the responsibility of supervisory code SP-05 or Planning group PL-50. Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. We are seeking a growth and improvement minded Engineering Maintenance & Utilities...

Merck Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of theCRD or Head of Site Management and Monitoring, the person is responsible to manage a teamof 6-14 CRAs and to ensure excellent study and site performance with strict adherence to localregulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training,support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment anddevelopment of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensurealignment across all monitoring functions. The person contributes to HQ capacity/resourceplanning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Work allocation,...

Merck Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of theCRD or Head of Site Management and Monitoring, the person is responsible to manage a teamof 6-14 CRAs and to ensure excellent study and site performance with strict adherence to localregulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training,support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment anddevelopment of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensurealignment across all monitoring functions. The person contributes to HQ capacity/resourceplanning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Work allocation,...

Merck Job Description The Associate Director, Business Insights and Analytics, will be responsible for developing and communicating data-driven and actionable insights that drive greater customer and market understanding to inform launch & go-to market strategies and help meet in-line commercial objectives. The individual in this role will be an independent contributor as well as lead a team and, together, will act as the Business Insight and Analytics Lead for the US Rare Disease marketing teams. The ideal candidate will lead an insight team consisting of functional teams across market research, data strategy, forecasting, resource effectiveness, measurement, marketing/sales operations, digital analytics, competitive insights and strategy. This person will help scope, design, and deliver well-defined projects and insights; and track value 'at stake' and value realized. The preferred candidate should have intellectual curiosity, entrepreneurial spirit, consultative...

Merck Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of theCRD or Head of Site Management and Monitoring, the person is responsible to manage a teamof 6-14 CRAs and to ensure excellent study and site performance with strict adherence to localregulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training,support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment anddevelopment of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensurealignment across all monitoring functions. The person contributes to HQ capacity/resourceplanning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Work allocation,...

Merck Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of theCRD or Head of Site Management and Monitoring, the person is responsible to manage a teamof 6-14 CRAs and to ensure excellent study and site performance with strict adherence to localregulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training,support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment anddevelopment of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensurealignment across all monitoring functions. The person contributes to HQ capacity/resourceplanning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Work allocation,...

Merck Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of theCRD or Head of Site Management and Monitoring, the person is responsible to manage a teamof 6-14 CRAs and to ensure excellent study and site performance with strict adherence to localregulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training,support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment anddevelopment of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensurealignment across all monitoring functions. The person contributes to HQ capacity/resourceplanning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Work allocation,...

Merck Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of theCRD or Head of Site Management and Monitoring, the person is responsible to manage a teamof 6-14 CRAs and to ensure excellent study and site performance with strict adherence to localregulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training,support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment anddevelopment of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensurealignment across all monitoring functions. The person contributes to HQ capacity/resourceplanning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Work allocation,...

Merck Job Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Specialist -Process Supervisor include the following: The process supervisor role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule,...

Merck Job Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Specialist -Process Supervisor include the following: The process supervisor role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule,...