3h ago
Senior Director, Clinical Development
Redwood City, California, United States
full-timedirectorbiotechnology
Description
You will lead clinical science aspects of clinical development strategy and documentation for our late-stage oncology pipeline targeting RAS-addicted cancers, driving transformative therapies from early research through pivotal studies and regulatory submissions.
Requirements
- PhD, PharmD or equivalent required
- Minimum 10+ years experience in clinical development (pharma R&D experience considered)
- Extensive experience in data analysis, interpretation, and clinical relevance
- Experience in independent trial design, protocol writing, ICF, and CRF construction
- Strong knowledge of GCP, ICH, FDA, EMA regulations
Responsibilities
- Lead clinical science aspects of clinical development strategy and documentation
- Oversee clinical trial design, execution, site selection, patient recruitment, data management, and regulatory compliance
- Manage clinical development timelines and resource allocation
- Lead, mentor, and contribute to a high-performing cross-functional team
- Establish and maintain relationships with clinical investigators, regulatory agencies, and stakeholders
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