1060 clinical operations excellence lead jobs found

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations,...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations,...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations,...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations,...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations,...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations,...

Legend Biotech USA Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. Role Overview The CAR-T Operations Manager is an exempt...

Legend Biotech USA Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for...

Biogen Job Description About This Role As the Manager, Medical Material Operations and Oversight Lead, you will be a pivotal member of the US Medical team, taking full accountability for the successful execution and optimization of the US Medical (USM) Material Review processes and activities. In addition to your primary focus on leading material review processes, you will dedicate a portion of your time to supporting the US neuropsychiatry therapeutic area as a Grants Coordinator. This dual-focus role combines process leadership with the opportunity to contribute to advancing medical and disease education through strategic grants coordination. You will report directly to the Director, Medical Excellence and Operations and collaborate with cross-functional teams to achieve operational excellence and strategic impact. What You'll Do Material Process Leadership: Act as a strategic partner to the Head of Science & Value Communication and USM Material Owners across...

Legend Biotech USA Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for...

Merck Job Description The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics including monoclonal antibodies (mAbs), di- & tri-specific antibodies, and fusion proteins as well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and development of formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. These sterile products include those administered via intravenous, subcutaneous, or intramuscular routes of administration. This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, processes...

Adapt Integrated Health Care Job Details Job Location : 621 W MADRONE - ROSEBURG, OR Position Type : Full Time Education Level : Graduate Degree Salary Range : Undisclosed Job Shift : Day Job Category : Executive Description Adapt Integrated Health Care is looking for a Medical Director to join our team! We Offer: 100% paid premiums for full family medical insurance Waiver cash option Dental and Vision insurance available Generous sick and vacation time accrual rates; accrued time rolls over year-to-year. 5% 401k employer contribution Life insurance policy Employee Assistance Program Clinical supervision toward licensure is available. The Medical Director is responsible for providing clinical oversight, direction, and leadership for all medical services, including those integrated within behavioral health settings, at Adapt Integrated Health Care. This role ensures the delivery of high-quality, patient-centered care in...

Aledade Aledade is actively recruiting for a Vice President of Quality. This senior leader is responsible for leading clinical quality performance for Aledade. The Vice President of Quality will serve as the single owner and single point of accountability for Aledade's quality goals across all lines of business, with a particular focus on Medicare Advantage Stars. This will include developing, maintaining, and executing on the strategic roadmap and providing vision and subject matter expertise for scalable tech-enabled workflows, primary care practice and clinician engagement, and centralized support functions. This outcome oriented role will lead through cross-functional influence, collaborating closely with peers across the business, including the VP of Pharmacy, VP of Product, SVP of Implementation, and other quality leaders to ensure quality performance is tightly integrated into Aledade's operating model. This leader will also collaborate with leaders in other...

CSL This position is a critical member of the Global Medical Affairs leadership, reporting into the Vice President, Medical Affairs Therapeutic Areas, who will work and coordinate with Medical Affairs stakeholders and cross-functional stakeholders to lead the design and implementation of all Medical Affairs evidence generation projects aligned with the business strategy. Responsibilities: Own the development and optimization and governance of strategic integrated evidence generation initiatives (ex. IIS, Phase IV clinical trials, NIS, RWE) across therapeutic areas for all country and global teams, proactively anticipating any potential gaps and adjusting tactical plans to address gaps. Provide oversight and leadership to ensure the Evidence Generation team supports MA sponsored studies in all country affiliates and provides strategic and scientific governance and oversight of IIS in collaboration with relevant teams within inline TAs, ensure timelines are met, contingency...

Alkermes, Inc. Overview: Great Science. Deep Compassion. Real Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio of proprietary marketed products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, and neurological disorders. Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed products across multiple locations and is committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity. The Associate Director of CMC Regulatory Affairs will support post-approval CMC...

Legend Biotech USA Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Supervisor is an...

Biogen Job Description About This Role The Medical Director, Global Medical Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues and may work with clinical programs as a medical advisor. May represent Biogen Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound/product. What You'll Do Manage safety surveillance for assigned products and collaborate with PV scientists and other stakeholders Conduct analyses of safety trial data. Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products...

Biogen Job Description About This Role: As a Therapeutic Area Lead within the Global Clinical Supply Chain team, you will be steering crucial end-to-end clinical supply chain planning for multiple products within a key therapeutic area in a dynamic and growth-orientated environment. You will captain a skilled team of supply chain professionals to oversee end-to-end clinical planning, manufacturing, and global distribution of investigational products in compliance with GXP and regulatory standards. In this pivotal role, you will deliver robust and efficient supply plans to accelerate clinical development of new treatments while maximizing our performance metrics and minimizing waste. As an organizational leader within the Global Clinical Supply Chain team, you will shape the strategic direction and initiatives within the department through innovative ways of working, fostering a culture of collaboration and striving for continuous improvement.  This is a hybrid role that...

Biogen Job Description About This Role: As a Therapeutic Area Lead within the Global Clinical Supply Chain team, you will be steering crucial end-to-end clinical supply chain planning for multiple products within a key therapeutic area in a dynamic and growth-orientated environment. You will captain a skilled team of supply chain professionals to oversee end-to-end clinical planning, manufacturing, and global distribution of investigational products in compliance with GXP and regulatory standards. In this pivotal role, you will deliver robust and efficient supply plans to accelerate clinical development of new treatments while maximizing our performance metrics and minimizing waste. As an organizational leader within the Global Clinical Supply Chain team, you will shape the strategic direction and initiatives within the department through innovative ways of working, fostering a culture of collaboration and striving for continuous improvement.  This is a hybrid role that...

CSL The Global Regulatory CTA Therapeutic Area Lead is a recognized SME in CTA and is responsible for the global management of Clinical Trial Authorizations (CTAs) with the view to obtain CTA approvals in the fastest and most efficient way while ensuring quality documentation. The Senior GRSL develops the CTA submission strategy of large and/or complex projects, provides regulatory project management of CTAs and oversees the CTA submissions. This role is responsible for developing, maintaining and improving processes, drive development and improvement of new systems, solutions and procedures related to CTA activities and ensure compliance with international regulatory requirements and internal CTA procedures. The Senior GRSL supports Global Regulatory Affairs (GRA) vision of excellence regarding CTA activities for assigned projects through strategy, good scientific practice, integrity and consistent compliance with local regulatory standards. Interface with GRA TA leads and...