Executive Director, Clinical Scientist

Key Responsibilities
- Contribute to the design/development of clinical trial protocols (scientific rationale, objectives, endpoints, eligibility).
- Author/review clinical documents (investigator brochures, informed consent forms, CSRs) and regulatory submissions.
- Provide scientific input during trial execution (protocol amendments, site engagement, data reviews, ongoing support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure trial conduct and data integrity.
- Conduct data reviews and support data interpretation with biostatistics/medical.
- Support regulatory document preparation for submissions and health authority meetings.
- Stay current on MASH/NASH therapeutic trends, competitive landscape, and regulatory guidance.
- Participate in cross-functional meetings and contribute to development strategies/timelines.

Experience and Key Requirements
- Advanced degree (PhD, MD, PharmD, or equivalent) required; Master’s with relevant experience may be considered.
- 12+ years clinical development/clinical research in pharma/biotech.
- 18+ years relevant experience.
- Prior liver disease, metabolic disorders, or MASH/NASH experience strongly preferred.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex data and present clearly; excellent verbal/written communication.
- Collaborative mindset; strong organization and project management.

Preferred Attributes
- Fast-paced biotech environment; small/agile teams.
- Familiarity with liver disease endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions.

Benefits and Application
- Full-time employees may receive flexible PTO, medical/dental/vision, life/disability insurance, and 401(k) offerings.
- Apply via the Madrigal Careers site (accepted on an ongoing basis).