Executive Director, Global Medical Safety
Vor 4 Tagen
**Executive Director, Global Medical Safety**
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
**The Opportunity**
**Responsibilities**
- Under supervision of the VP, Head of Drug Safety, and as per company policies and procedures, for assigned Denali programs, has the responsibility and oversight of the risk-benefit strategy and execution
- Responsible for program-level safety strategic planning, implementation, and management of drug safety activities to support clinical development through optimized benefit-risk for patients.
- Responsible for leading the program level Safety Management Team(s) to develop and execute plans pertaining to safety signal management, safety surveillance and risk. Responsible for risk characterization and internal/external safety communication for the molecule. Provide expert safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs
- Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
- Responsible for responding to and resolving safety questions from regulatory authorities.
- Responsible for the production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide
- Collaborates for consistency in safety approaches within drug safety group and with cross-functional colleagues, e.g. medical monitors, toxicologist and pharmacologist
- Support regulatory agency audits and inspections, and corrective action plans
- Support overall growth and operations of Denali and the Drug Safety department. Lead initiatives in developing safety processes and and continuous pharmacovigilance (PV) process improvement. Support PV vendor oversight in collaboration with Safety Operations
**Minimum Qualifications**:
- Advanced medical degree (e.g., MD, MBBS, DO) required
- 7+ years of experience in the pharmaceutical industry. A minimum of 3 years leading cross-functional safety teams in the clinical trial and post
- marketing environments.
- Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
- Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics
- Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
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