Associate Director, Global Clinical Safety Scientist

Job description

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. Reporting to the Vice President, Global Clinical Safety & Aggregate Reporting, the Associate Director, Global Clinical Safety Scientist will contribute to Clinical Safety & Pharmacovigilance (CSPV) activities by supporting the development and maintenance of safety assessments for assigned Madrigal clinical products in conjunction with the CSPV Physician and cross-functional team members. Position Specific Responsibilities: ● Serve as the safety scientist for assigned projects, with responsibility for coordinating clinical safety activities and escalating complex safety matters as appropriate ● In collaboration with the CSPV physician, contribute to the authoring and review of relevant safety sections of study documents, including Protocols, Informed Consent Forms (ICFs), and Investigator’s Brochures ● Provide research and analytical support to the CSPV physician for safety questions arising during clinical development and protocol development, including evaluation of potential safety mitigations ● Evaluate safety data from clinical studies (e.g., Excel files and Tables, Figures & Listings [TFLs]), including analysis and summarization of key safety findings to support internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs) ● Contribute to safety sections of regulatory submissions and responses, including but not limited to INDs, NDAs, and MAAs ● Prepare and present safety data review materials for Technical Committee, Protocol Review Committee, Safety Review Team, and other relevant forums ● Collaborate with the Safety Surveillance Team in the identification and evaluation 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 the development, review, and finalization of safety-related documents ● Collaborate with the CSPV physician in developing safety content by applying knowledge of the product 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 ● Experience contributing to the development or improvement of safety and PV processes highly desirable ● Experience coordinating with external vendors or partner teams ● Experience working effectively within 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 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 10 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry, including experience as a Safety Scientist Travel: • Up to 10% travel may be required 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. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $169,220 - $201,940 per year. We comply with all applicable minimum wage laws. 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. Full-time employees are also eligible for comprehensive benefits, including 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. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides 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 HR@madrigalpharma.com. 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. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or