BioPhase · 3 weeks ago
Director of Clinical Science
BioPhase is seeking an experienced, motivated Clinical Scientist to join their oncology team. The Director will provide medical-scientific expertise to one or more clinical programs, focusing on early-phase development.
Responsibilities
Collaborate with clinical leadership to develop clinical development plans and strategies for oncology programs
Draft and review protocol synopses, protocols, amendments, and informed consent forms
Update clinical sections of investigator brochures and lead related documentation efforts
Contribute to clinical and safety sections of NDAs/MAAs and clinical study reports
Serve as medical representative on study teams, reviewing safety data, adverse events, and study results
Prepare internal and external presentations, train colleagues, CROs, and site staff, and participate in advisory boards
Conduct therapeutic area research, competitor analysis, and maintain investigator and opinion leader networks
Support Health Authority interactions, inspections, submissions, and internal audits
Assist Medical Monitor in Phase 2/3 trials, ensuring patient safety and providing guidance throughout trial design, execution, and reporting
Participate in program-level activities, including safety and efficacy summaries, clinical overviews, risk management plans, periodic safety updates, and labeling content
Qualification
Required
Bachelor's degree required
Minimum 4 years industry experience in oncology clinical development, with involvement across all trial stages
Skilled in protocol design, clinical monitoring, and safety assessment
Knowledge of Good Clinical Practice (GCP)
Preferred
advanced degree (MD, PharmD, PhD, or Master's in clinical oncology) preferred
Experience with small molecule trials preferred
Company
BioPhase
BioPhase Solutions specializes in staffing and recruiting professionals for pharmaceutical, biotech and medical device companies.
Funding
Current Stage
Early StageCompany data provided by crunchbase