Key Responsibilities
- Contribute to the design and development of clinical trial protocols, including scientific rationale, study objectives, endpoints, and eligibility criteria.
- Author or review key clinical documents such as investigator brochures, informed consent forms, clinical study reports (CSRs), and 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 therapeutic area trends, competitive landscape, and regulatory guidance related to MASH/NASH and associated comorbidities.
- Participate in cross-functional meetings; contribute to development strategies and timelines.
Experience and Professional Qualifications
- Advanced degree (PhD, MD, PharmD, or equivalent) in a life sciences field required; Masterβs with relevant experience may be considered.
- 10+ years of experience in clinical development or clinical research in the pharmaceutical/biotechnology industry.
- 15+ years relevant experience.
- Prior experience in liver disease, metabolic disorders, or MASH/NASH strongly preferred.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data and present clearly.
- Excellent verbal and written communication skills.
- Collaborative mindset; strong organizational and project management abilities.
Preferred Attributes
- Experience in a fast-paced biotech environment with small, agile teams.
- Familiarity with liver disease endpoints (histology, imaging, or non-invasive biomarkers).
- Experience supporting regulatory interactions or submissions (plus).