Senior Director, Medical Safety Science

POSITION SUMMARY

We are seeking astrategic leader who is responsible for safety aspects of clinical development and post market surveillance of medicinal products in the Mirum portfolio. The Senior Director of Medical Safety Science will join an established, world-class medical safety team and will collaborate closely with the existing medical safety operations team.

JOB FUNCTIONS/RESPONSIBILITIES

• Participates in the development and review of appropriate safety sections of key safety documents including: IBs, CSRs, ISS, NDAs, MAAs, IB, ICF, RSI, CDS.
• Oversees the preparation of DSURs, IND Annual Reports, PSURs/PBRERs and other global periodic safety reports.
• Protocol Design and Evidence Generation: Manages the planning and preparation of the adverse events section of protocols and informed consents for clinical studies.
• Liaises with Medical Monitors in Clinical Development, EU QPPV, contract medical reviewers etc. as needed to ensure that appropriate medical review and assessment is provided for assigned case reports.
• Medical Review of CSR/other types of narratives as needed.
• Participates in IDMC, IRB/ECs and Ad Board and the development and management of Data Monitoring Committees, including development of DMC Charters and QA/QC of required line-listings and aggregate summaries of applicable safety data.
• Assists in Benefit-Risk assessment in collaboration with Clinical Development.
• Manages the Signal and Risk Management processes for each product throughout the life cycle.
• Identifies and reports on possible trends and concerns as they relate to Mirum products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
• Supports activities for Investigator Sponsored Trials (ISTs), including review of protocols, informed consents, IST contracts, and appropriateness of safety data received from IST trials.
• Reviews aggregate safety data from the clinical DB in support of Data Monitoring Committee meetings, interim analyses or final DB lock.
• Participates in/leads Mirum Safety governance committees as needed.
• Participates in health authority interactions (both written and verbal) and audits/inspections regarding safety and risk management.

QUALIFICATIONS

Education/Experience:

• MD/DO or equivalent, or PharmD required.
• Minimum 6 years of drug safety, clinical research, or healthcare related experience.
• A minimum of 4 years must be derived from pharmaceutical industry experience directly working in Medical Safety with clinical development and post-marketing.
• Global experience is preferred.

Knowledge, Skills and Abilities:

• Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environment is a must.
• Familiarity with safety databases (Veeva) is a plus.

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