6 jobs found in Middletown, DE

Position Overview: The Senior Clinical Scientist will be a key member of a clinical development team supporting protocol development and study delivery. The position holder works closely with the CDT Lead and other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs. Work Environment: *** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly.  Relocation assistance and visa sponsorship are not provided Key Responsibilities: Under general direction, contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan Provides scientific input for the safe, efficient, and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs Contributes to the development of program and core clinical development...

Job Purpose: The Associate Director, Medical Affairs is responsible for leading the development and execution of the US Medical Affairs strategy for assigned therapeutic area(s). The role provides scientific leadership across evidence generation, publication strategy, medical planning, and cross-functional initiatives while serving as a trusted scientific partner to internal and external stakeholders. RESPONSIBILITIES AND ACCOUNTABILITIES Accountable for leading the development of the evidence generation strategy Provide US medical affairs input into the development of global publication strategies and plans for therapeutic area(s), and support the execution of US publication priorities Lead the medical plan for therapeutic area(s) Leads development, execution, and ongoing optimization of the annual US Medical Affairs Plan for assigned therapeutic area(s), ensuring alignment with global strategy and business priorities. Provides scientific oversight for localization...

Work Environment: *** This is a hybrid position with a minimum of 3 days onsite required on a weekly basis.  Relocation and mobility assistance are not provided. Main Responsibilities: Contributes to the scientific development of clinical development programs and individual studies in alignment with the clinical development plan within the Hematology therapeutic area Provides scientific and clinical development input for the safe, efficient and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs Author and/or contribute to the development of program and study level documents and training materials aigned with the scientific strategy (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, and investigator trainings) Contributes to the development of the medical monitoring oversight strategy for individual clinical studes and implements it to ensure the highest level of patient safety...

The Role: Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.  Manages  case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility. Manages the delivery of the Safety Reporting Plans, ; identifies, implements, and monitors KPIs/KQIs across clinical case management activities; Supports the preparation and conduct of PV and other GxP inspections and audits, as required, . Establishes, maintains, and/or ensures maintenance of  clinical trial case management required documents, such as safety reporting plans and reporting responsibilities  , in line with international and national regulations, guidelines, and internal standards. Oversee the Vendors to ensure GSPV standards are...

Position Overview: The Associate Director, Global Clinical Scientist role is a key leadership role in the Clinical Development group and is a multifunctional, clinical project position that will support the Hematology Therapeutic Area.  The position may be delegated aspects of Clinical Development Team (CDT) leadership depending on the needs of the program. The incumbent works closely with other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs, including approximately 30-40% external innovation assessment, Search & Evaluation support, and due diligence responsibilities, depending on program needs and status. Work Environment: *** This is a hybrid position with a minimum of 3 days onsite required on a weekly basis.  Relocation assistance and visa sponsorship are not provided. Key Responsibilities: Provide scientific leadership in the development of clinical...

Director, Clinical Pharmacology Locations: King of Prussia, PA or Glattbrugg, Switzerland Work Arrangement: Hybrid – 3 days onsite Reports To: Senior Director, Clinical Pharmacology Lead About CSL CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. Through a project-led structure and a strong focus on collaboration, we are building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing innovative therapies that make a meaningful difference for patients around the world. The Opportunity CSL is seeking a Director, Clinical Pharmacology to provide clinical pharmacology and pharmacometrics expertise across a range of programs within its R&D portfolio. This individual will lead clinical pharmacology strategy, guide pharmacokinetic/pharmacodynamic (PK-PD) assessments, and drive the application of modeling and simulation to support drug...