Global Clinical Safety Leader

Madrigal; Conshohocken (Montgomery County); On-site; USD 213,000 - 260,000; Full time

Benefits offered by this job

Equity

Flexible paid time off

Medical insurance

Dental insurance

Vision insurance

Life/disability insurance

401(k) with employer match

Voluntary benefits

Employee assistance program

Job summary

Madrigal is seeking a Director, Global Clinical Safety Scientist to lead safety evaluations for clinical programs and collaborate across CSPV and cross-functional teams. You will author safety sections for protocols and regulatory submissions, analyze complex safety data, and present findings to internal committees.

Ideal candidates bring 12+ years in clinical safety/pharmacovigilance, strong MedDRA/WHO terminology knowledge, and experience with safety databases.

Qualifications

• Minimum Bachelor’s degree in a relevant scientific discipline.
• Clinical experience (BSN, PharmD) preferred but not required.
• Advanced degree preferred: PharmD, PhD, NP/PA, or Master’s with relevant experience.

Responsibilities

• Serve as the lead safety scientist for assigned projects.
• Author, review and provide feedback on study documents (ICF, Protocol, Investigator’s Brochure).
• Support safety sections of regulatory submissions (IND, NDA, MAA).
• Analyze safety data for DRCs, DMCs, and CSRs; summarize key safety findings.
• Create and present safety data reviews to committees.
• Collaborate with CSPV physician and cross-functional teams on safety content.
• Identify safety signals with Safety Surveillance Team and draft responses.
• Lead cross-functional safety content development and reviews.
• Travel up to 10% may be required.

Skills

Global safety regulations

Analytical thinking

Regulatory submissions

Written & verbal communication

Detail orientation

Health data interpretation

MedDRA/WHO terminology

Safety process design

Managing external teams

Cross-functional leadership

Safety databases (Argus)

EDC for clinical data

Education

Bachelor’s degree in relevant scientific discipline

Clinical experience (e.g., BSN, PharmD) preferred

Advanced degree (PharmD/PhD/NP-PA or Master’s) with relevant experience

Tools

Argus

EDC systems

Job description

Madrigal is seeking a Director, Global Clinical Safety Scientist to lead safety evaluations for clinical programs and collaborate across CSPV and cross-functional teams. You will author safety sections for protocols and regulatory submissions, analyze complex safety data, and present findings to internal committees.

Ideal candidates bring 12+ years in clinical safety/pharmacovigilance, strong MedDRA/WHO terminology knowledge, and experience with safety databases.