Director. Global Clinical Safety Scientist

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

Benefits offered by this job

Flexible paid time off

Medical, dental, and vision insurance

Equity options

401(k) plans

Job summary

Madrigalpharma, based in Conshohocken, PA, is looking for a Director, Global Clinical Safety Scientist to oversee safety assessments of clinical products. Your role will involve collaborating with various stakeholders, including physicians, to ensure compliance with safety regulations and mitigate risks associated with clinical trials.

The ideal candidate will have over 12 years of relevant experience, a strong understanding of regulatory submissions, and excellent analytical skills. Madrigalpharma fosters a collaborative culture, providing a competitive salary and equity as part of the compensation package.

Qualifications

• Minimum 12 years of experience in clinical safety or pharmacovigilance in the pharmaceutical industry.
• Experience as a Safety Scientist is essential.
• Ability to create presentations on safety data for various committees.

Responsibilities

• Lead safety assessments for Madrigal clinical products.
• Collaborate with physicians to ensure safety standards are met.
• Analyze and summarize safety data from clinical studies.

Skills

Team collaboration

Analytical skills

Regulatory submission experience

Medical record interpretation

Safety database familiarity

Education

Bachelor's degree in relevant scientific discipline

Advanced degree (PharmD, PhD, NP/PA)

Tools

MedDRA

WHO Drug terminology

Job description

## Director. Global Clinical Safety ScientistApplylocations: PA - Conshohocken - Officetime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR\_000777Madrigal 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, 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 [ex. 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 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 requiredMadrigal’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 $213,000 - $260,000 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 [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. 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 in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.* *Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to* *[e-mail]**.*