Website HanchorBio Inc.
Job Responsibilities
- Manage projects timeline and budget from research, toxicology studies, IND filing to early-stage clinical
- Develop and maintain detailed target product profiles (TPPs), project plans and risk & mitigation plans
- Coordinate with cross-functional teams to drive project timeline, organize/ lead project meetings, and track action items until resolution
- Evaluate, negotiate, execute, and coordinate all outsourced activities including but not limited to vendors, CROs, and CDMOs
- Collaborate with consultants for clinical and regulatory activities, including communication with regulatory agencies, clinical sites etc.
Job Requirements
- Master’s Degree in life sciences, nursing, pharmacy or equivalent (Ph.D. Degree is highly preferred)
- More than six years of related preclinical and/or clinical experience of biologics in the biotechnology/pharmaceutical industry
- In-depth knowledge of pharmaceutical development and clinical development
- Experience in project management and clinical/regulatory affairs
- Proficient in the Microsoft suite of business software including MS Projects and Access and other clinical/regulatory softwares
- Evidence of building relationships with and managing expectations of stakeholders at all levels and externally, to persuade on business benefits and gain acceptance to changes
- Excellent written and oral communication, collaboration and “think-out-of-the box” problem-solving skills; performance-driven, reliable team player with strong sense of responsibility
- Comfortable meeting deadline in a fast-paced biotech environment