Senior Director, Global Safety Physician

Regulatory Toolkit; Waltham (MA); On-site; USD 318,000 - 388,000; Full time

Benefits offered by this job

Flexible paid time off

Medical, dental, vision insurance

Life/disability insurance

401(k) offerings

Job summary

Madrigal is seeking a Senior Director, Global Safety Physician to lead medical safety strategy for investigational and marketed products. This leader will oversee safety data review, signal detection, and benefit–risk assessment across studies and postmarketing, collaborating with Global Clinical Safety, Regulatory Affairs, Biostats, and Clinical Operations.

The role also covers authoring safety documents, supporting regulatory filings (INDs, NDAs/BLAs), inspection readiness, and leading Safety

Qualifications

• MD or equivalent medical degree with licensure or eligibility for licensure.
• 15+ years of combined, relevant experience in industry, clinical safety, pharmacovigilance, or related roles within biotech/pharma.
• Deep knowledge of FDA, EMA, PMDA and other regulatory body interaction.

Responsibilities

• Medical Oversight & Signal Management: oversee safety data review, signal detection, and benefit–risk evaluation for assigned compounds.
• Regulatory & Scientific Contributions: author/ review safety content for regulatory documents; support INDs/NDAs/BLAs and safety responses.
• Cross-functional Collaboration: align safety strategy with Clinical Development, Biostats, and Regulatory Affairs; contribute to governance forums.

Skills

GCP

ICH E2E

GVP modules

global regulatory safety

leadership

regulatory interactions

Education

MD or equivalent medical degree

Tools

Argus

ArisGlobal

MedDRA

Job description

Position Responsibilities:

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).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

The Senior Director, Global Safety Physician plays a key role in ensuring patient safety in clinical studies and those receiving marketed products. This role is responsible for continuous assessment of safety data, signal detection, and benefit-risk evaluation for assigned compounds in development and in the postmarketing setting. The role requires strong collaboration within Global Clinical Safety and Pharmacovigilance and across Clinical Development, Regulatory Affairs, Biostats, and Clinical Operations, with leadership and key contributions to regulatory filings and global safety governance activities.

The Senior Director will serve as a medical expert for safety matters, supporting both investigational and marketed products. Additionally, the role will lead clinical safety strategy, author and review safety-related documents and responses to health authority queries, and support regulatory interactions.

Key Responsibilities

Medical Oversight & Signal Management

• Provide medical oversight for clinical safety signals, including review and interpretation of safety data from clinical trials, spontaneous reports, and literature.
• Lead or participate in safety signal detection, evaluation, validation, and documentation in collaboration with safety scientists and other stakeholders.
• Serve as a key member or chair of Safety Management Teams (SMTs), contributing to benefit–risk assessments and mitigation strategies.

Regulatory & Scientific Contributions

• Author or medically review safety content in critical regulatory documents such as:
  • DSURs, PBRERs, RMPs, IBs, and safety sections of clinical study reports
• Provide expert medical input for regulatory filings and interactions, including INDs, NDAs/BLAs, and safety responses to agency queries.
• Support inspection readiness and audit activities related to clinical safety documentation.

Cross-functional Collaboration

• Partner with Clinical Development, Biostats, and Regulatory Affairs to align on safety strategy and ensure scientifically sound decision-making.
• Collaborate with PV Operations, Safety Data Management, and Medical Review teams to ensure quality and consistency in safety case evaluations.
• Participate in internal governance forums such as Safety Review Committees (SRCs) or benefit–risk assessment boards.

Experience and Professional Qualifications:

The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company:

• Deep knowledge of GCP, ICH E2E, GVP modules, and global regulatory safety expectations
• Proven track record of leadership across phase I-IV studies and familiarity with post-marketing surveillance processes
• Experience with safety database systems (e.g. Argus, ArisGlobal), MedDRA, and safety signal detection tools
• Experience in a matrixed global environment
• Specialty training in relevant therapeutic areas a plus
• Excellent strategic thinking, problem-solving, and influencing skills
• Deep knowledge of FDA, EMA, PMDA and other regulatory body interaction

The ideal candidate displays the following professional competencies:

• Senior-level leadership and communication skills
• Strategic thinker with deep scientific and regulatory knowledge
• Sound judgment in risk-benefit evaluation
• Ability to make decisions in uncertainty
• Ability to influence and align cross-functional stakeholders at all levels
• Ability to deliver executive briefings and board-level updates
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and technical writing skills
• Ability to present clearly using scientific and regulatory terminology
• Fluent in English language

Educational & Experience:

• MD or equivalent medical degree with licensure or eligibility for licensure
• 15+ years of combined, relevant experience in industry, clinical safety, pharmacovigilance, or related roles within biotech / pharma

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $318,000 - $388,000 per year.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

• Flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• Supplemental life insurance
• Legal services
• Other offerings
• Mental health benefits through our Employee Assistance Program for employees and their family.
• Other benefits in accordance with applicable federal, state, and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

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.