Director of Clinical Science

Job Responsibilities:
- Develop/oversee clinical study concept synopses and protocols; participate in protocol review.
- Prepare study protocols/amendments and Investigator meeting materials with Medical Writing and Clinical Operations; coordinate with writing vendors.
- Contribute to CRFs, Data Management Manuals, and Data Analysis Plans.
- Review ongoing clinical data, work with CROs to resolve queries and ensure data readiness for database locks.
- Organize/oversee Data Review Committee meetings and related materials.
- With MD supervision, address investigator scientific/procedural questions; participate in site initiation/start-up.
- Maintain relationships with investigators/site staff; support key thought-leader input.
- Prepare/review data listings, summary tables, study results, manuscripts, and scientific presentations.
- Assist in preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.

Qualifications:
- Bachelor’s (Biological Sciences/healthcare/related) + 8+ years relevant clinical science/drug development OR MS + 6+ years OR PharmD/PhD + 5+ years.
- Fast learner; flexible/adaptable across projects.
- Microsoft Office (Excel, PowerPoint) and SpotFire; knowledge of FDA/EMA/ICH regulations.
- Excellent verbal/written communication and cross-functional collaboration.

Benefits (high level):
- Health coverage; wellbeing support; 401(k), disability and life insurance, and other financial protection.
- Paid Time Off (flexible time off or annual paid vacation per location).