Chief Safety Officer
4 days ago
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.
Job SummaryWe are seeking a seasoned Chief Safety Officer to lead our Patient Safety organization and provide strategic direction and governance of all Patient Safety Activities at Kyverna. The successful candidate will be responsible for overseeing effective cross-functional and cross-regional alignment to achieve business objectives of Patient Safety and ensure that patient wellbeing is the primary consideration in all Kyverna endeavors.
Key Responsibilities- Accountable for the overall strategic leadership of the emerging Patient Safety Department, and of Patient Safety activities across the company.
- Ensuring effective safety decision-making throughout the life-cycles of all Kyverna medicinal products.
- Creating a scientifically driven safety strategy for Kyverna products, using a translational safety approach, taking into account scientific principles, prior research and development results, literature, competitive intelligence, and disease area principles.
- Actively identify and monitor safety signals and safety issues based on holistic analysis of all available information, in line with the safety strategy, detect signals that are not anticipated.
- Lead the workup of current and potential safety issue and provide independent medical and regulatory judgments on critical, time sensitive Patient Safety and compliance matters.
- Chair the Safety Governance Board where safety decisions and actions are endorsed in a cross-functional setting.
- Develop risk management and risk minimization strategies and implement them in the development process, compassionate use programs, and regulatory filings.
- Ensure that safety strategies and decisions are cascaded to all relevant stakeholders and implemented in protocols, IB, IC and other regulatory and information material.
- Take a leadership role in the management of a safety-related crisis.
- MD or similar medical qualification with several years of clinical experience exercising medical judgment as a physician.
- 12+ years of industry experience with a minimum of 8+ years of experience in Patient Safety in a global environment, including leading roles, functions and activities.
- Clinical development experience in oncology and/or immunology, experience with advanced therapeutic medicinal product would be beneficial.
- Ability to combine Patient Safety expertise with exceptional leadership (strategic thinking, people and resource management both within direct and indirect reporting lines).
- Experienced in building leading diverse teams and cross-functional leadership, working collaboratively with stakeholders.
- Strong analytical ability and experience in decision-making at a senior level with excellent judgment in risk-assessed decision-making, strong problem-solving approach, solution- and results-orientated.
- Experienced with budget planning and management, and resource planning, recruitment and effective deployment.
- Experienced in working with diverse service providers and consultants, able to set expectations and drive delivery.
- Flexible and able to work in a fast-paced, rapidly changing environment on multiple projects with aggressive deadlines.
- Team-oriented with strong interpersonal skills and ability to collaborate effectively with others.
- Hard-working, energetic, hands-on and passionate about making a difference; demonstrates and models a positive "can do" attitude, being empowering to collaborators.
- Self-confident and articulate, with excellent verbal and written communication skills, able to represent the company effectively in matters of Patient Safety externally.
- Sensitive to diversity and inter-cultural differences, able to build effective collaborations across functional and geographic boundaries, lead change and promote learning and development for individuals and collectively.
- Character of the highest integrity, with strong ethical and scientific standards.
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