Director. Global Clinical Safety Scientist

Director, Global Clinical Safety Scientist

Position Specific 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 on safety questions during clinical development and determine safety mitigations
- Evaluate clinical safety data (e.g., excel files or TFLs) and summarize key findings for DRCs, DMC meetings, and CSRs
- Support safety sections of regulatory submissions and responses (IND, NDA, MAA)
- Create/present safety slide decks for review committees
- Collaborate with Safety Surveillance to identify safety signals; author safety summaries and respond to inquiries from HCPs/regulators
- Collaborate cross-functionally on context, review, and finalization of documents
- Develop safety content with CSPV physician by applying the safety profile and summarizing findings

Specialized Knowledge & Skills
- Knowledge of global safety regulations
- Strong analytical/critical thinking; detailed-oriented
- Excellent written/verbal communication
- Ability to interpret health/medical records
- Experience with MedDRA and WHO Drug terminology and narrative writing
- Prior PV/safety process design highly desirable; external team management and leading matrix teams
- Safety database experience (Argus a plus) and EDC experience

Qualifications
- Minimum: Bachelor’s in relevant scientific discipline
- Preferred: PharmD, PhD, NP/PA, or Master’s with relevant experience
- Minimum 12 years clinical safety/pharmacovigilance (including Safety Scientist experience)
- Travel up to 10%

Benefits: Full-time employees may be eligible for flexible PTO, medical/dental/vision, life/disability insurance, and 401(k).

Application: Submit via the Madrigal Careers site (ongoing basis).