Key Responsibilities
- Contribute to design/development of clinical trial protocols: scientific rationale, objectives, endpoints, eligibility criteria.
- Author/review key clinical and regulatory documents (investigator brochures, informed consent forms, CSRs, regulatory submissions).
- Provide scientific input during execution (protocol amendments, site engagement, data reviews, ongoing study support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure trial quality and data integrity.
- Conduct data reviews and support data interpretation with biostatistics/medical.
- Support regulatory submission and health authority meeting document preparation and internal governance presentations.
- Stay current on MASH/NASH therapeutic trends, competitive landscape, and regulatory guidance.
- Participate in cross-functional meetings; contribute to strategies and timelines.
Experience and Professional Qualifications
- Advanced degree (PhD/MD/PharmD or equivalent) required; masterβs with relevant experience may be considered.
- 2+ years clinical development or clinical research in pharma/biotech.
- 10+ years relevant experience.
- Strong preference: prior liver disease, metabolic disorders, or MASH/NASH experience.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data; strong verbal/written communication.
- Collaborative mindset; strong organizational and project management.
Preferred Attributes
- Experience in fast-paced biotech with small, agile teams.
- Familiarity with liver disease endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions (plus).
Benefits
- Full-time employees eligible for comprehensive benefits, including flexible PTO, medical/dental/vision, life/disability, and 401(k) offerings.
Application Instructions
- Submit via Madrigal Careers site on an ongoing basis.