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 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 $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.
