Job Description
Are you ready to redefine the boundaries of medical science? BioVanguard Pharmaceuticals is seeking a visionary Senior Clinical Research Scientist to lead high-stakes Phase II and III clinical trials within our Oncology pipeline. In this role, you will be at the epicenter of therapeutic innovation, translating complex biological data into life-saving treatments.
We offer a high-performance environment where scientific rigor meets creative problem-solving. As a key member of our Global Clinical Development team, you will collaborate with world-class investigators to design protocols that set new industry standards. If you are driven by data integrity and patient outcomes, BioVanguard provides the platform and resources to elevate your career to its highest potential.
Responsibilities
- Lead the strategic design and execution of global clinical trial protocols, ensuring alignment with corporate clinical development plans.
- Serve as the primary clinical point of contact for cross-functional teams, including Regulatory Affairs, Data Management, and Medical Writing.
- Analyze and interpret complex clinical data sets to identify trends, safety signals, and efficacy outcomes.
- Author high-quality clinical study reports (CSRs), investigator brochures (IBs), and regulatory submission documents for the FDA and EMA.
- Manage relationships with external Contract Research Organizations (CROs) and Key Opinion Leaders (KOLs) to ensure trial milestones are met on schedule.
- Provide expert clinical oversight during site selection, initiation, and monitoring visits to ensure strict adherence to ICH-GCP guidelines.
Qualifications
- Ph.D., PharmD, or MD in a relevant scientific or medical field is strictly required.
- Minimum of 7 years of clinical development experience within a pharmaceutical or biotechnology setting.
- Proven track record of successful Phase II/III trial management and regulatory filings (NDA/BLA).
- Deep expertise in Oncology, Immunology, or Rare Disease therapeutic areas.
- Exceptional command of ICH-GCP, FDA regulations, and international clinical trial standards.
- Advanced analytical skills with proficiency in SAS, R, or similar clinical data visualization tools.
- Superior communication skills with the ability to influence executive-level stakeholders.