- Olema Oncology (Boston, MA)
- …patients feel better, longer. For more information, visit us at www.olema.com. About the Role Senior Director , Quality Assurance - GCP/ GVP The Senior ... functions Submissions Related : Accountable for Quality review of non- clinical and clinical trial documentation, and documents submitted to regulatory… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …lead the clinical development activities in support of domestic and international clinical development initiatives. The Senior Director , GCD works in a ... clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all...integrity of the methodology and ensure the safety of clinical subjects. + Leading clinical trial… more
- Norstella (Providence, RI)
- …& analytics **Requirements** + Deep knowledge and expertise of the pharma strategic Clinical trial landscape (Clin Dev/Ops, clinical development plan ... Sr. Director /VP/ Clinical Delivery Lead, Advisory Services Company:...+ Experience using data analytics and services to solve clinical trial challenges + Understanding of how,… more
- Lilly (Boston, MA)
- …experience with a Masters or PhD background as a plus. + Extensive early phase clinical trial experience, with at least 5-7 years in industry (or equivalent ... for our partners and patients. **Purpose of the Role:** The Director [commensurate with experience], ExploR&D Translational Medicine incumbent is responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as a Medical Director , Clinical Sciences - Plasma Derived Therapies in our Cambridge office. At Takeda, ... and plasma-oriented therapies for patients with serious, complex diseases. The Medical Director - Immunodeficiency leads and drives strategy for the overall global… more
- Takeda Pharmaceuticals (Boston, MA)
- …Reporting to the Head of Strategic Partnerships and Outsourcing, the Executive Director Clinical Partner Outsourcing (CPO) is a strategic leadership role ... focus on continuous improvement + Strong understanding of GCP, ICH guidelines, and clinical trial regulations **ADDITIONAL INFORMATION** + The position will be… more
- Bausch + Lomb (Providence, RI)
- …consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes ... Summary** **:** Is responsible for the implementation and oversight of clinical study operations by organizing and coordinating with other relevant parties… more
- Takeda Pharmaceuticals (Boston, MA)
- …Join us as the Director , Operational Systems based remotely reporting to the Senior Director , Trial Delivery Systems Strategy. At Takeda, we are ... management for operational systems and roadmap evangelism. + Supports the Sr. Director , Trial Delivery Systems Strategy in leading cross-functional efforts to… more
- Sumitomo Pharma (Providence, RI)
- …marketed products. + Conduct safety surveillance over product life cycle, reviewing clinical trial and post-marketing Individual Case Safety Reports (ICSRs), ... and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will provide...safety of clinical trials, including monitoring of clinical trial safety and laboratory data. +… more
- ICON Clinical Research (Boston, MA)
- …or in other situations, as assigned by manager. + Lead the presentation of clinical trial related information/data to senior management, as assigned by ... As a Medical Director , you will be joining the world's largest...for the overall integrity of the data in the clinical trial . **You Are:** + Physician with… more
- Takeda Pharmaceuticals (Boston, MA)
- … senior level management input or alignment. + Strategic business partner from clinical trial development through the marketing maintenance phase of a product ... and innovative promotional platforms + Act as a strategic partner spanning clinical trial development through the marketing and maintenance phases of… more
- Takeda Pharmaceuticals (Boston, MA)
- …is responsible for shaping and delivering strategic technology solutions that support clinical trial operations, enhance data quality, and accelerate drug ... we do begins with our commitment to putting patients first. As a Director , Technology Business Partner for Global Development Operations, you will play a key… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …including an understanding of strengths and limitations of a methodological approaches and clinical trial designs + Possess an enterprise mindset and experience ... ** Director , Integrated Evidence & Digital Health** Otsuka is...a critical partner to Early Phase & Translational Medical, Clinical Development, Value and Real-World Evidence, Regulatory, Medical Affairs,… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. **_Objective / Purpose:_** Reporting to the Senior Director , Strategic Partnerships and Outsourcing Enablement (SPO), the ... and interpersonal skills + Strong understanding of GCP, ICH guidelines, and clinical trial regulations **Takeda Compensation and Benefits Summary** We understand… more
- Takeda Pharmaceuticals (Boston, MA)
- …addressing safety -elated regulatory authority requests (2 years); apply clinical trial methodology, various regulatory submissions, pharmacovigilance ... Global Medical Safety team, you will report to the Senior Medical Director , GI and work with...ability to perform advanced searches. + In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile,… more
- Takeda Pharmaceuticals (Boston, MA)
- …as a Manager, Global Trade Compliance based in Cambridge/Lexington, MA reporting to the Senior Director - Global Clinical Supply Chain Import Export ... and import compliance policies and procedures for the organization regarding Clinical Trial Material (CTM) and raw material shipments. + Manage daily import… more
