- BeOne Medicines (Emeryville, CA)
- …integrate regulatory feedback to strengthen enrollment practices and operational quality . + Build and maintain relationships with research sites and external ... **General Description:** Reporting to the Head /Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …including but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), ... Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head , reporting to the VP, Translational Medicine and Early Clinical Development within… more
- Sanofi Group (Waltham, MA)
- …of the job/major challenges** + (S)He interacts with other GBS teams, Clinical, Regulatory , Global Program Head , Regulatory , Immunology, Medical ... affairs plans, studies and submissions activities (when applicable), including quality , relevance to external stakeholders (eg regulatory authorities,… more
- ThermoFisher Scientific (Greenville, NC)
- …+ May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely ... a chance to engage in innovative projects that will profoundly shape global healthcare. Our Project Delivery team directs, coordinates and leads the technical… more
- Astellas Pharma (Northbrook, IL)
- …and interfaces with Drug Discovery through Marketing. + Direct experience leading global regulatory marketing authorization submissions and defense of those ... in the Immuno-Oncology group. + Reports to the Medical Lead/disease area strategy head for the given program(s) and is accountable for defining the strategy and… more
- Taiho Oncology (Princeton, NJ)
- …and/or EU Regulatory authorities is preferred. + Highly detail and quality oriented. + Ability to learn, integrate complex information, and communicate clinical ... guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Under the direction of the Head of Clinical Pharmacology (TA- Inflammation), the incumbent would: + Provide visionary leadership for the BIPI ... comprehensive CPS strategy working closely with the CPhL, DMPK, Safety Science Leads, CP head of inflammation and CPS head of inflammation. + Provide expert… more
- Genentech (South San Francisco, CA)
- …solutions and lifecycle governance for platform technologies + You are familiar with global regulatory guidance on digital endpoints, PROs, DCTs, and AI/ML use ... science, and digital product thinking, DEPCS delivers scalable and regulatory -ready innovations that enhance trial design, evidence generation, and clinical… more
- CSL Behring (Waltham, MA)
- …and is onsite three days a week. You will report to the Senior Director, Global Lead and Head Research and Clinical Bioanalytics. You will lead a specialized ... and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission readiness and associated risks.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Inflammation will ... (TA), and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in the TA. The ideal candidate will have a proven… more