Director, Clinical Scientist
Madrigal Pharmaceuticals
10 days ago
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Director, Clinical Scientist (Clinical Trials)
Key Responsibilities
- Contribute to design and development of clinical trial protocols (rationale, objectives, endpoints, eligibility criteria).
- Author or review key clinical/regulatory documents (investigator brochures, informed consent forms, CSRs, regulatory submissions).
- Provide scientific input during execution (protocol amendments, site engagement, data reviews, ongoing study support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure data integrity.
- Conduct data reviews and support data interpretation with biostatistics and medical teams.
- Support regulatory submission documents and health authority/internal governance materials.
- Stay current on MASH/NASH therapeutic trends and regulatory guidance; participate in cross-functional strategy/timeline meetings.
Experience And Professional Qualifications (Required)
- Advanced degree (PhD, MD, PharmD, or equivalent); Master’s with relevant experience may be considered.
- 5+ years clinical development/research in pharma/biotech.
- 12+ years relevant experience.
- Strong knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data; excellent written/verbal communication.
- Collaborative mindset; strong organizational/project management.
Preferred Attributes
- Experience in fast-paced biotech with small/agile teams.
- Familiarity with liver disease endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions.
Benefits (as stated)
- Base salary range: $215,000–$264,000/year; bonus and equity; flexible PTO; medical/dental/vision/life-disability insurance; 401(k) options; EAP.
Application Instructions
- Apply on an ongoing basis via the Madrigal Careers site.
Key Responsibilities
- Contribute to design and development of clinical trial protocols (rationale, objectives, endpoints, eligibility criteria).
- Author or review key clinical/regulatory documents (investigator brochures, informed consent forms, CSRs, regulatory submissions).
- Provide scientific input during execution (protocol amendments, site engagement, data reviews, ongoing study support).
- Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure data integrity.
- Conduct data reviews and support data interpretation with biostatistics and medical teams.
- Support regulatory submission documents and health authority/internal governance materials.
- Stay current on MASH/NASH therapeutic trends and regulatory guidance; participate in cross-functional strategy/timeline meetings.
Experience And Professional Qualifications (Required)
- Advanced degree (PhD, MD, PharmD, or equivalent); Master’s with relevant experience may be considered.
- 5+ years clinical development/research in pharma/biotech.
- 12+ years relevant experience.
- Strong knowledge of ICH/GCP and global clinical trial regulations.
- Ability to synthesize complex scientific data; excellent written/verbal communication.
- Collaborative mindset; strong organizational/project management.
Preferred Attributes
- Experience in fast-paced biotech with small/agile teams.
- Familiarity with liver disease endpoints (histology, imaging, non-invasive biomarkers).
- Experience supporting regulatory interactions/submissions.
Benefits (as stated)
- Base salary range: $215,000–$264,000/year; bonus and equity; flexible PTO; medical/dental/vision/life-disability insurance; 401(k) options; EAP.
Application Instructions
- Apply on an ongoing basis via the Madrigal Careers site.