Senior Director, Clinical Scientist
Madrigal Pharmaceuticals
10 days ago
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Senior Director, Clinical Scientist
Key Responsibilities
- Contribute to design/development of clinical trial protocols (rationale, objectives, endpoints, eligibility criteria).
- Author/review key clinical documents (investigator brochures, informed consent forms, CSRs, regulatory submissions).
- Provide scientific input during execution (protocol amendments, site engagement, data reviews, ongoing support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure data integrity.
- Conduct data reviews and support data interpretation.
- Support regulatory submission documents, health authority meetings, and internal governance presentations.
- Stay current on MASH/NASH therapeutic trends and regulatory guidance; contribute to development strategies and timelines.
Experience and Professional Qualifications (Required)
- Advanced degree (PhD, MD, PharmD, or equivalent); Master’s with relevant experience may be considered.
- 10+ years in clinical development/clinical research (pharma/biotech).
- 15+ years relevant experience.
- Prior experience in liver disease/metabolic disorders/MASH-NASH strongly preferred.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex data; strong verbal/written communication; collaborative mindset; strong organization/project management.
Preferred Attributes
- Fast-paced biotech experience with small agile teams.
- Familiarity with liver endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions (plus).
Benefits
- Full-time employees may be eligible for comprehensive benefits including flexible paid time off, medical/dental/vision, life/disability, and 401(k).
Application Instructions
- Submit via the Madrigal Careers site (applications accepted on an ongoing basis).
Key Responsibilities
- Contribute to design/development of clinical trial protocols (rationale, objectives, endpoints, eligibility criteria).
- Author/review key clinical documents (investigator brochures, informed consent forms, CSRs, regulatory submissions).
- Provide scientific input during execution (protocol amendments, site engagement, data reviews, ongoing support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure data integrity.
- Conduct data reviews and support data interpretation.
- Support regulatory submission documents, health authority meetings, and internal governance presentations.
- Stay current on MASH/NASH therapeutic trends and regulatory guidance; contribute to development strategies and timelines.
Experience and Professional Qualifications (Required)
- Advanced degree (PhD, MD, PharmD, or equivalent); Master’s with relevant experience may be considered.
- 10+ years in clinical development/clinical research (pharma/biotech).
- 15+ years relevant experience.
- Prior experience in liver disease/metabolic disorders/MASH-NASH strongly preferred.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex data; strong verbal/written communication; collaborative mindset; strong organization/project management.
Preferred Attributes
- Fast-paced biotech experience with small agile teams.
- Familiarity with liver endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions (plus).
Benefits
- Full-time employees may be eligible for comprehensive benefits including flexible paid time off, medical/dental/vision, life/disability, and 401(k).
Application Instructions
- Submit via the Madrigal Careers site (applications accepted on an ongoing basis).