Senior Director, Clinical Scientist

Senior Director, Clinical Scientist — Clinical trials for assets targeting MASH (metabolic dysfunction-associated steatohepatitis).

Key Responsibilities
- Contribute to design/development of clinical trial protocols (scientific rationale, objectives, endpoints, eligibility criteria).
- Author or review key clinical/regulatory documents (investigator brochures, informed consent forms, CSRs, 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 data integrity and high-quality conduct.
- Conduct data reviews and support data interpretation with biostatistics and medical.
- Support 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 and 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.
- 10+ years clinical development/research in pharma/biotech.
- 15+ years relevant experience.
- Prior experience in liver disease, metabolic disorders, or MASH/NASH strongly preferred.
- Knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data and communicate clearly.
- Excellent verbal and written communication.
- Collaborative mindset with strong organizational/project management.

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