Director, Clinical Scientist

Director, Clinical Scientist

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

Experience and Professional Qualifications
- Advanced degree (PhD, MD, PharmD, or equivalent) required; Master’s with relevant experience may be considered.
- 5+ years in clinical development or clinical research in pharma/biotech; 12+ years relevant experience.
- Strong preference for prior experience in liver disease, metabolic disorders, or MASH/NASH.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data and communicate clearly.
- Excellent verbal/written communication; strong organizational and project management skills.

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

Application Instructions
- Apply through the Madrigal Careers site (applications accepted on an ongoing basis).