Director. Global Clinical Safety Scientist

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

Benefits offered by this job

Flexible paid time off

Medical, dental, vision and life/disability insurance

401(k) offerings with employer match

Mental health benefits via Employee Assistance Program

Job summary

Madrigal Pharmaceuticals is seeking a Director, Global Clinical Safety Scientist to lead safety assessments for clinical products. The role requires over 12 years in clinical safety within the pharmaceutical industry.

With a salary range of $213,000 – $260,000, the position includes benefits like flexible paid time off, medical plans, and equity. Ideal candidates will have strong analytical skills, a relevant Bachelor's degree, and experience with regulatory submissions.

Qualifications

• Minimum 12 years of experience in clinical safety or pharmacovigilance.
• Prior experience in designing safety and PV processes is highly desirable.
• Experience with MedDRA and WHO Drug terminology.

Responsibilities

• Serve as the lead safety scientist for assigned projects.
• Evaluate safety data from clinical studies and summarize key findings.
• Collaborate with stakeholders to develop safety content.

Skills

Strong analytical and critical thinking skills

Excellent written and verbal communication skills

Good knowledge of global safety regulations

Experience contributing to regulatory submissions and safety reports

Detailed-oriented

Education

Bachelor’s degree in a relevant scientific discipline

Advanced degree (PharmD, PhD, NP/PA, or Master's)

Tools

Safety databases (Argus preferred)

Job description

Overview

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once‑daily, oral, liver‑directed THR‑β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety Scientist will play a key role within Clinical Safety & Pharmacovigilance (CSPV) to develop and maintain safety assessments for all Madrigal clinical products in conjunction with the CSPV Physician and cross‑functional team members.

Position Specific Responsibilities

• Serve as the lead safety scientist for assigned projects
• In collaboration with CSPV physician, author, review and provide critical feedback to relevant sections of study documents including Protocol, Informed Consent Form (ICF), Investigator’s Brochure
• Provide research support to CSPV physician for safety questions that arise during clinical development, protocol development or determine appropriate safety mitigations
• Evaluate safety data from clinical studies [e.g. excel files or Tables, Figures & Listings (TFLs)] including analysis and summary of key safety findings for internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs) (i.e. actual assessment of safety data)
• Support safety sections of submission filings and regulatory responses including but not limited to IND, NDA, and MAA
• Create and present safety slide presentations of data reviews for Technical Committee, Protocol Review Committee, Safety Review Team, etc.
• Collaborate with Safety Surveillance Team on the identification of safety signals from clinical trials, analysis and authoring of safety data summaries, and preparation of responses to safety inquiries from healthcare professionals and regulatory agencies
• Collaborate with cross‑functional stakeholders in development of context, review, and finalization of documents
• Collaborate with CSPV physician in the development of safety content by applying knowledge of safety profile and summarizing relevant findings
• Perform additional tasks, as directed by management

Specialized Knowledge & Skills

• Good knowledge of global safety regulations
• Strong analytical and critical thinking skills
• Experience contributing to regulatory submissions and safety reports
• Excellent written and verbal communication skills
• Excellent in detailed-oriented tasks
• Ability to interpret health and medical records
• Experience with MedDRA and WHO Drug terminology and its application, and narrative writing
• Prior experience in designing safety and PV processes highly desirable
• Experience in managing external teams
• Experience leading cross‑functional matrixed teams
• Experience with safety databases; Argus is a plus but not mandatory
• Experience with EDC for clinical trial data collection

Educational Requirements

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

Experience

• Minimum 12 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry inclusive of experience as a Safety Scientist

Travel

• Up to 10% travel may be required

Benefits

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and includes base pay, bonus and equity. Base salary is estimated at $213,000 – $260,000 per year. All full‑time employees receive equity, flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (traditional, Roth, and employer match). Additional voluntary benefits include supplemental life insurance, legal services, and other offerings. The company also offers mental health benefits through an Employee Assistance Program.

Equal Opportunity Employer

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.