Director. Global Clinical Safety Scientist

Director, Global Clinical Safety Scientist

Position Responsibilities
- Serve as lead safety scientist for assigned projects
- Author/review/provide critical feedback to study documents (Protocol, ICF, Investigator’s Brochure) with CSPV physician
- Support CSPV physician with safety questions and safety mitigations during clinical development
- Evaluate clinical safety data (e.g., Excel/TFLs), summarize key findings for DRC, DMC, and CSRs
- Support safety sections of regulatory submissions and responses (IND, NDA, MAA)
- Create/present safety slide decks for technical/protocol/safety review forums
- Collaborate with Safety Surveillance on safety signal identification, safety data summaries, and responses to HCP/regulatory inquiries
- Collaborate cross-functionally to develop/review/finalize documents
- Develop safety content by summarizing relevant findings based on safety profile

Specialized Knowledge & Skills
- Global safety regulations; strong analytical/critical thinking; excellent written/verbal communication; detail-oriented
- Interpret health/medical records
- MedDRA and WHO Drug terminology; narrative writing
- Prior PV/safety process design experience (desirable)
- Experience managing external and cross-functional matrix teams
- Safety databases (Argus a plus); EDC experience (clinical trial data collection)

Qualifications
- Minimum BS in relevant scientific discipline required; clinical experience (e.g., BSN, PharmD) preferred
- Advanced degree preferred (PharmD, PhD, NP/PA, or Master’s with relevant experience)
- Minimum 12 years in clinical safety/pharmacovigilance (including Safety Scientist experience)
- Up to 10% travel

Benefits
- Flexible paid time off; medical/dental/vision and life/disability insurance; 401(k); supplemental life and legal services; Employee Assistance Program (mental health)

Application Instructions
- Submit via Madrigal Careers site on an ongoing basis.