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, CSRs, 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 high-quality trial conduct and data integrity.
- Conduct data reviews and support data interpretation with biostatistics and the medical team.
- Support preparation of documents for regulatory submissions, health authority meetings, and internal governance presentations.
- Stay current on MASH/NASH therapeutic trends, competitive landscape, and regulatory guidance.
- Participate in cross-functional meetings; 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: 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 (verbal/written).
- Collaborative mindset; strong organizational and project management skills.

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

Application Instructions
- Apply via Madrigal Careers site (ongoing basis).