Remotely
gcpclinical developmentregulatory submissionsibscsrsprotocol developmentcase report formsdata review plans
Job Description
📋 Description
- Lead clinical science on respiratory studies (asthma/COPD) for Phase 2/3 trials.
- Drive protocol development, data analysis, and regulatory documentation.
- Collaborate across Clinical Development, Regulatory, Biostatistics, Data Management, and Safety.
- Oversee medical monitoring, data quality, patient safety, and protocol compliance.
- Support investigator site engagement, CROs, and vendor oversight with scientific input.
- Contribute to study governance, publication plans, and risk assessments.
🎯 Requirements
- Advanced degree (PhD, PharmD, MD, MS, PMP) with 9+ years in industry clinical development.
- Expertise in late-stage respiratory studies and trial design/execution.
- Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP.
- Proven ability to lead clinical science strategy and execution in late-stage trials.
- Excellent analytical, communication, and cross-functional collaboration skills.
- Experience authoring clinical protocols, CSRs, and regulatory documents.
🎁 Benefits
- Annual bonus, equity compensation, and competitive benefits package.
- Opportunity to contribute to groundbreaking AI-driven biology programs.
- Remote work with occasional travel to HQ as needed.