Director, Clinical Scientist
Madrigal Pharmaceuticals
12 hours ago
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Director, Clinical Scientist
Key Responsibilities
- Contribute to design/development of clinical trial protocols (scientific rationale, objectives, endpoints, eligibility).
- Author/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 support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure data integrity.
- Conduct data reviews and support data interpretation with biostatistics/medical team.
- Support preparation for regulatory submissions, health authority meetings, and internal governance presentations.
- Stay current on MASH/NASH trends, competitive landscape, and regulatory guidance.
- Participate in cross-functional meetings; contribute to development strategies and timelines.
Experience and Key Requirements
- PhD/MD/PharmD (or equivalent) in life sciences required; Master’s with relevant experience may be considered.
- 5+ years clinical development/research in pharma/biotech; 12+ years relevant experience.
- Strongly preferred: liver disease, metabolic disorders, or MASH/NASH experience.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data and communicate clearly.
- Excellent verbal/written communication; collaborative mindset; strong organizational/project management.
Preferred Attributes
- Fast-paced biotech experience with small teams.
- Familiarity with liver endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions (plus).
Benefits (full-time)
- Flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) offerings.
Application Instructions
- Apply via the Madrigal Careers site (ongoing basis).
Key Responsibilities
- Contribute to design/development of clinical trial protocols (scientific rationale, objectives, endpoints, eligibility).
- Author/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 support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure data integrity.
- Conduct data reviews and support data interpretation with biostatistics/medical team.
- Support preparation for regulatory submissions, health authority meetings, and internal governance presentations.
- Stay current on MASH/NASH trends, competitive landscape, and regulatory guidance.
- Participate in cross-functional meetings; contribute to development strategies and timelines.
Experience and Key Requirements
- PhD/MD/PharmD (or equivalent) in life sciences required; Master’s with relevant experience may be considered.
- 5+ years clinical development/research in pharma/biotech; 12+ years relevant experience.
- Strongly preferred: liver disease, metabolic disorders, or MASH/NASH experience.
- Solid knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data and communicate clearly.
- Excellent verbal/written communication; collaborative mindset; strong organizational/project management.
Preferred Attributes
- Fast-paced biotech experience with small teams.
- Familiarity with liver endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions (plus).
Benefits (full-time)
- Flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) offerings.
Application Instructions
- Apply via the Madrigal Careers site (ongoing basis).