- Takeda Pharmaceuticals (Lexington, MA)
- … by Design (AQbD) principles, aligning with ICH Q14, ICH Q2(R2), and global regulatory expectations for biologics. + Lead technical assessments and risk ... control strategies. + Solid knowledge of late-stage analytical development, including global regulatory requirements for Biologics (US, EU, Japan, China).… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Patient & HUB Operations, Rare Disease** . The Director , Patient… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality , and commercial functions + Coordinate interdepartmental ... across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device… more
- Sumitomo Pharma (Boston, MA)
- …Senior Leadership Team. + Collaborate with the process and analytical development, quality , and regulatory functions to establish a robust, compliant clinical ... in bringing clinical molecules to successful commercial products within different Global Markets, including leading regulatory filings. + Successfully executed… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Research Director **Location** : Morristown, NJ Cambridge, MA **About the Job** Ready to push the limits of what's possible? Join Sanofi in ... to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Clinical Research Director , I and I, Pulmonology **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... be critical in helping our teams accelerate progress. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director - Packaging Technology **Location** : Cambridge, MA, Morristown, NJ, Swiftwater, PA & Toronto, ON **About the Job** We deliver 4.3 billion ... bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in… more
- ICON Clinical Research (Boston, MA)
- …with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory , safety, quality , and project management, or others, ... As a Medical Director , you will be joining the world's largest...or clinical programs. + Represent Clinical Development on the Global Program Team (GPT) and in presentations at management… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the Global Medical Safety ... Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical… more
- ThermoFisher Scientific (Boston, MA)
- …Join PPD, a part of Thermo Fisher Scientific, as a **Sr Account Director /Executive Account Director , Business Development** **Biotech** and take on the exciting ... developing and executing a strategic sales plan to maximize business from your assigned global key accounts. In this pivotal role, you will drive revenue growth by… more