322 executive director global regulatory portfolio lead global regulatory affairs jobs found

About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. We give it our all every day because we believe in the power of targeted oncology to...

SUMMARY/JOB PURPOSE: The Executive Director acts as the head of Clinical Pharmacology and Pharmacometrics to build and maintain an experienced team focused on large molecules and new therapeutic modalities including monoclonal antibodies, bispecifics and ADC. This role also oversees Clinical Pharmacology/DMPK biologics and advanced data analytics. Essential Duties And Responsibilities: *Build and supervise a team responsible for pipeline delivery from discovery to Phase 4. Provide preclinical PK, toxicokinetics, and clinical PK/PD expertise to project teams. Progress biologics and new modalities through major milestones including IND/CTA, EOP2 and marketing applications. *Advanced data analytics: build capabilities and supervise a team responsible for pharmacometrics, ML/AI and bioinformatics. In addition to clinical pharmacology deliverables, the team will provide support to the Translational Medicine group. *Develop and implement clinical pharmacology and...

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our...

Vice President of Academic Affairs (VPAA) Job ID: 319166 Location: GateWay Community College Full/Part Time: Full Time Regular/Temporary: Regular Hiring Salary Range $130,515-$169,669/annually DOE Grade 128 Work Schedule Monday - Friday, 8am - 5pm; some evenings and weekends may be required Summer Hours: Monday - Thursday, 7am-6pm Work Calendar 12 Months Maricopa Summary Are you looking for a place to work where you can make a real difference in the lives of over 200,000 college students every year? Would you like to be part of an organization that adds $7.2 billion dollars to the economy and supports nearly 100,000 jobs in the fastest growing county in the United States? Whether you're teaching, working, or learning Make It Happen At Maricopa County Community Colleges! About Us What's Currently Happening at Maricopa Many of our campuses have received grant awards through the National Science Foundation to improve undergraduate...

SUMMARY/JOB PURPOSE: ** Please note this requires a 3 day onsite presence, Monday, Tuesday and Thursday. **Also, ADC trial experience is required. The Senior Director, Clinical Operations (ClinOps) is responsible for the worldwide execution of all Phase I - IV clinical trials across the Exelixis portfolio. ClinOps plays a key role in ensuring all Exelixis clinical trials are performed in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Exelixis' products. The Senior Director, Clinical Operations represents ClinOps at the Product Development Team (PDT) as the Clinical Operations Program Lead. The Clinical Operations Program Lead is accountable for developing the operational strategy and delivery plan to execute the scientific strategy for a product(s) and associated studies, working in partnership with clinical / biostats / clinical...

About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. We give it our all every day because we believe in the power of targeted oncology to...

About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. We give it our all every day because we believe in the power of targeted oncology to...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU...

About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. We give it our all every day because we believe in the power of targeted oncology to...