- Pfizer (Collegeville, PA)
- …equivalent preferred Breast Oncology experience (2+ years) **Organizational Relationships** Reports to Global Development Lead and partners closely with ... across several study teams. + Serve as the Clinical Development Lead on subteams including for Marketing...Guidance, Clinical Insights & Interpretation + Collaborate with the Global Development Team to create and refine… more
- Pfizer (Collegeville, PA)
- …the study team in governance meetings and submissions, partners with/supports the Development lead /Medical Director regarding study and disease area strategy. + ... and quality of clinical trial(s) in support of the development strategy for programs within the Late -Stage...aimed at improving the efficiency and quality of clinical development + Has a global perspective and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …leading to NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy and execution for assigned programs after ... Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in...compliance with GCP, regulatory requirements, and internal processes. + Lead and contribute to development of clinical… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …+ Develop and implement global CMC regulatory strategies for late -stage development , marketing applications (eg, NDA/MAA), and post-approval lifecycle ... to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development , Quality, Manufacturing, Global Regulatory… more
- Insight Global (King Of Prussia, PA)
- …of Prussia, PA. This role is fully on site, 5 days/week and will lead downstream process development efforts focused on the chromatographic purification of ... team (6 reports max) in designing and executing purification strategies that support late -stage development and manufacturing readiness. This role will be 50%… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …planning, global preferred + Proven success leading cross-functional teams through late -stage development and global commercialization + Expertise in ... impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + ** Global Launch Leadership & Market Preparation:** Lead cross-functional … more
- Organon & Co. (Plymouth Meeting, PA)
- …and Early Development (TMED) Department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study design and oversight of ... literature and regulatory guidance and support the approved early development plans. The Clinical Pharmacology Lead will...on the EDP (TMED scope: first-in-man to Phase 2a), late -stage development plans or, for mature or… more
- Insight Global (Lower Gwynedd, PA)
- …early to late -stage clinical readiness for rapid progression of process development . This position will be focused on designing, optimizing, and executing assays ... a Scientist to join their growing Decisional Analytics team within the Cell Therapy Development group under the R&D Cell & Gene Therapy organization. This group is… more
- Parexel (Harrisburg, PA)
- …our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll ** lead cross-functional teams** , manage ... **Title: Principal Real World Research Delivery Lead (RWRDL)** **Location:** US - Remote Are you...and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join… more
- Sumitomo Pharma (Harrisburg, PA)
- …Experience in conducting global clinical trials in both early- and late -stage clinical development , especially protocol development and trial initiation ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and Europe, and a diverse pipeline of early- to late -stage assets, we aim to accelerate discovery, research, and… more