Vice President, Global Medical Safety

The Vice President, Global Medical Safety will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely benefit-risk assessments of all safety data. The VP, Global Medical Safety will provide strategic and tactical leadership and oversee all aspects of pharmacovigilance and risk management activities through all stages of clinical development (Phase I-IV) as well as post-marketing patient safety. This position reports directly to the GVP Global Medical Affairs and will be evaluating, refining, updating, and growing the Drug Safety & Pharmacovigilance function at Kiniksa.

This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Job Responsibilities

• Lead global clinical, medical, and scientific safety, pharmacovigilance, and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline
• Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with the team
• Responsible for the content of Risk Management Plan/ REMS as required
• Ability to effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities
• Be the senior strategic leader providing a strong, clear voice for the drug safety program and have a clear next-generation vision for Global Patient Safety and Risk Management
• Build and manage a high-growth global medical safety team by setting clear expectations & providing hands-on leadership, promoting collaboration and team cohesiveness.
• Provide strategic consultation, guidance and oversight for safety sections of all regulatory documents, including but not limited to NDA/BLA/MAA, EU Risk Management Plans/REMS, PSUR/PBRERs, DSURs, ICFs, public presentations and key scientific articles and abstracts.
• Provide medical guidance and evaluation of all pre- and post-marketing safety data
• Responsible for final review and sign-off with respect to all controlled documents
• Collaborate cross-functionally and with key internal and external stakeholders, including regulatory agencies, alliance partners, KOLs, and senior management
• Ensure all relevant SOPs and systems/ processes are in place making for an efficient and compliant organization
• This leader will be expected to roll-up their sleeves and help achieve targets in addition to managing direct reports
  
  

Education And Experience

• MD, or MD PhD, or MD MPH required D. or educational equivalent is required. U.S. Licensure and Board Certification are preferred.
• A minimum of 15+ years’ experience as the Head of Drug Safety/Patient Safety/ Product Safety & Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company.
• Direct knowledge and experience of major filings such as IND, CTA, NDA, and MAAs.
• Entrepreneurial, small/high-growth company biologics experience is preferred or rare disease experience is a plus.
• Experience working in a fast-paced environment and building and growing teams.
• Proven ability and history of establishing and maintaining strong alliance relationships with biotech/pharma partner.
• Managing all aspects of post-marketing product safety in US, EU, and other major territories.
• Outstanding communication and presentation skills.
• Comfortable working with Senior Executive Team and on occasion with Board members, and other external audiences such as KOLs, regulatory bodies, and investors.
• Experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention.
• Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics.
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA
  
  

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.