A clinical-stage biopharmaceutical company is seeking an Associate Director or Director of Clinical Science in the United States. This role involves leading clinical scientific execution for oncology trials, authoring protocols, and ensuring scientific rigor in regulatory submissions. The ideal candidate has an advanced degree, extensive clinical development experience, particularly in oncology, and the ability to collaborate effectively with cross-functional teams. A dynamic environment awaits where roles can evolve rapidly.
Qualifications
5-10+ years of clinical development experience in biotech or biopharma.
Direct experience in oncology clinical development, especially Phase 1 trials.
Demonstrated authorship of clinical protocols and regulatory documents.
Responsibilities
Lead clinical scientific execution for Phase 1/2 oncology programs.
Author and review clinical protocols and regulatory submissions.
Provide oversight on adverse events and protocol deviations.
Design and interpret PK/PD and efficacy analyses.
Collaborate with KOLs and provide scientific input on site selection.
Skills
Clinical development
Oncology expertise
Regulatory knowledge
Scientific communication
Education
MD, PharmD, or PhD in a relevant scientific discipline
Job description
A clinical-stage biopharmaceutical company is seeking an Associate Director or Director of Clinical Science in the United States. This role involves leading clinical scientific execution for oncology trials, authoring protocols, and ensuring scientific rigor in regulatory submissions. The ideal candidate has an advanced degree, extensive clinical development experience, particularly in oncology, and the ability to collaborate effectively with cross-functional teams. A dynamic environment awaits where roles can evolve rapidly.