- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …**Job Description** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience ... commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior...clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …onsite in one of our locations. Relocation is provided to those who qualify._ The ** Senior Clinical Study Lead** (CSL) is expected to operate with ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug...initiatives + Responsible for identification of innovative approaches to clinical study execution including global … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- … Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, ... **Job Summary** The Senior Manager of Global Quality Management...throughout the clinical development lifecycle. **Key Responsibilities** ** Clinical Study Support** + Serve as a… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …organizes consultations with global subject matter experts - Represents the clinical ECD&ES function on clinical study teams, contributing ... We are seeking a Senior Manager to join our Clinical ...in terms of indication selection, study rationale, scientific/ clinical endpoints - POC-enabling human studies , First-In-Human… more
- Parexel (Albany, NY)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical ... in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and ... management of Otsuka clinical studies , including coordination with other relevant...Contribute to the development and review of all critical clinical study documents, including clinical … more
- Sumitomo Pharma (Albany, NY)
- …area. **Job Duties and Responsibilities** + Responsible for and lead all activities related to clinical study design from clinical study concept to ... highly complex decisions + Leads and drives strategy for clinical studies for assigned asset(s) within the... clinical trial results and the writing of clinical study reports + Contributes to the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support ... The Senior Medical Director, Clinical Development, will...from Global Patient...to key external presentations. + Ensures quality of all clinical documents (eg, Investigators' Brochure, protocol, study … more
- Pfizer (New York, NY)
- …informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical ... for programs within the Late-Stage Oncology portfolio. **KEY RESPONSIBILITIES** + Clinical development expert for assigned studies maintaining current scientific… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …Pharmaceutical Development & Commercialization, Inc. (OPDC) a USA subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of ... physicians and scientists who lead clinical development activities for Otsuka's global health-care products. The Global Clinical Development Program… more