Director. Global Clinical Safety Scientist
Madrigal Pharmaceuticals
June 28, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Position Specific Responsibilities:
- Serve as the lead safety scientist for assigned projects.
- Author, review, and provide critical feedback (in collaboration with CSPV physician) to study documents including Protocol, Informed Consent Form (ICF), and Investigator’s Brochure.
- Provide research support for safety questions during clinical development and protocol development, including safety mitigation recommendations.
- Evaluate safety data from clinical studies (e.g., excel files or Tables, Figures & Listings) and summarize key safety findings for internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs).
- Support safety sections of submission filings and regulatory responses (IND, NDA, MAA).
- Create and present safety slide presentations for committees (Technical Committee, Protocol Review Committee, Safety Review Team, etc.).
- Collaborate on safety signal identification, analysis and authoring of safety data summaries, and responses to safety inquiries from healthcare professionals and regulators.
- Collaborate cross-functionally on document context, review, and finalization.
- Collaborate with CSPV physician on safety content development.
- Perform additional tasks as directed by management.
Specialized Knowledge & Skills:
- Good knowledge of global safety regulations; strong analytical/critical thinking.
- Experience contributing to regulatory submissions and safety reports.
- Excellent written/verbal communication; detail-oriented; ability to interpret health/medical records.
- Experience with MedDRA and WHO drug terminology and narrative writing.
- Prior experience designing safety/PV processes (highly desirable).
- Experience managing external teams and leading cross-functional matrixed teams.
- Safety database experience (Argus plus); EDC experience.
Educational Requirements:
- Minimum Bachelor’s in relevant scientific discipline (clinical experience preferred, not required).
- Advanced degree preferred (PharmD, PhD, NP/PA, or Master’s).
Experience:
- Minimum 12 years in clinical safety or pharmacovigilance (including Safety Scientist experience).
Travel:
- Up to 10%.
Application instructions:
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).
- Serve as the lead safety scientist for assigned projects.
- Author, review, and provide critical feedback (in collaboration with CSPV physician) to study documents including Protocol, Informed Consent Form (ICF), and Investigator’s Brochure.
- Provide research support for safety questions during clinical development and protocol development, including safety mitigation recommendations.
- Evaluate safety data from clinical studies (e.g., excel files or Tables, Figures & Listings) and summarize key safety findings for internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs).
- Support safety sections of submission filings and regulatory responses (IND, NDA, MAA).
- Create and present safety slide presentations for committees (Technical Committee, Protocol Review Committee, Safety Review Team, etc.).
- Collaborate on safety signal identification, analysis and authoring of safety data summaries, and responses to safety inquiries from healthcare professionals and regulators.
- Collaborate cross-functionally on document context, review, and finalization.
- Collaborate with CSPV physician on safety content development.
- Perform additional tasks as directed by management.
Specialized Knowledge & Skills:
- Good knowledge of global safety regulations; strong analytical/critical thinking.
- Experience contributing to regulatory submissions and safety reports.
- Excellent written/verbal communication; detail-oriented; ability to interpret health/medical records.
- Experience with MedDRA and WHO drug terminology and narrative writing.
- Prior experience designing safety/PV processes (highly desirable).
- Experience managing external teams and leading cross-functional matrixed teams.
- Safety database experience (Argus plus); EDC experience.
Educational Requirements:
- Minimum Bachelor’s in relevant scientific discipline (clinical experience preferred, not required).
- Advanced degree preferred (PharmD, PhD, NP/PA, or Master’s).
Experience:
- Minimum 12 years in clinical safety or pharmacovigilance (including Safety Scientist experience).
Travel:
- Up to 10%.
Application instructions:
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).