Head of Global Safety and Pharmacovigilance
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
The Head of Global Safety and Pharmacovigilance is being established at Kyverna to be the nucleus of the future Patient Safety organization. This is a global role responsible for providing dynamic leadership, strategic direction and governance of all Patient Safety Activities at Kyverna, service providers and partners. The mission will be adjusted as the organization matures. This position reports to the Vice President, Global Regulatory Affairs and leads the Safety Governance Board to take decisions on the safety profile and benefit-risk of Kyverna products and is a member of the appropriate leadership teams and quality boards to represent Patient Safety, while also inputting into aspects of the overall R&D strategy. Partnerships with key stakeholders will be paramount. This includes internal stakeholders such as Clinical Development, Medical Affairs, Regulatory Affairs, Compliance and Commercial as well as external stakeholders, which includes investigators, service providers, consultants and various regulatory bodies around the world.
The Head of Global Safety and Pharmacovigilance will oversee effective cross-functional and cross-regional alignment to achieve the business objectives of Patient Safety and ensure that patient wellbeing is the primary consideration in all Kyverna endeavors.
This position requires a seasoned leader to oversee all aspects of Patient Safety with the following main mission:
Safety Organization: Build the Kyverna Patient Safety organization organically, in line with the evolution of the company, and in collaboration with internal partner functions and external service providers, with a focus on scientific expertise, compliance and global reach.
Safety Data: Develop a comprehensive view of safety data to facilitate close to real time analysis of the safety profile of Kyverna products, by physically consolidating ICSR into a unified safety database (the database itself being outsourced) and by having appropriate visibility to safety data in clinical databases and other uses.
Safety Strategy: Create a scientifically driven safety and risk management/risk minimization strategy for Kyverna products, using a translational safety approach, and implement the strategy in all development and commercialization activities.
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 crises.
> Patient Safety in clinical development and compassionate use programs
- Liaise with clinical development teams, compassionate use participants and service providers to establish comprehensive and timely access to relevant safety data.
- Ensure that a comprehensive safety database for ICSR is in place and all expedited and periodic reporting requirements are met.
- Ensure that assessment of SAE is timely and robust, including definitions of adverse events of special interest with respective follow up procedures and adjudication committees.
- Work with clinical teams and provide input into development plans, study protocols, CRF, IB, IC periodic reports, regulatory submissions and others from a safety perspective to ensure consistency and messaging in line with the safety profile of the product and the safety strategy.
- Lead the medical evaluation of product quality complaints, health hazard assessment of manufacturing deviations and participate in the implementation of product quality related actions.
>Ensuring the Kyverna Pharmacovigilance System is appropriate in terms of structure and performance, by maintaining oversight of all relevant aspects of the functioning of the system, including the associated Quality System including:
- Defining and leading a global policy and strategy for Kyverna Patient Safety for both investigational and authorized products worldwide.
- Building and leading a talented global Patient Safety team to ensure that the Patient Safety function is operationalized according to the highest industry standards and that all associated personnel are informed and fully compliant with company Policies and SOPs, continuously coaching, developing, and mentoring the team.
- Evaluating the effectiveness of Patient Safety structures and processes, planning and executing changes for greatest success in alignment with the emerging Kyverna operating model and plans.
- Developing and enhancing Patient Safety capabilities and expertise for the future, including the creation, administration, and monitoring of the overall Patient Safety budget.
> Effective collaboration
- Be the spokesperson for Kyverna Patient Safety to all relevant internal and external audiences (including investigators, regulatory agencies, auditors and inspectors) with an authoritative view on the safety profile of the product, the adequacy of risk management and risk minimization, safety strategy and the compliance of the PV system.
- Maintain up-to-date knowledge of relevant current ICH guidelines, FDA and EU regulations, and other regulations globally, and ensure translation of these into fully implemented and operating Kyverna processes to secure an industry-benchmarked regulatory-compliant PV and associated Quality system.
- Ensure proactive intelligence on evolving regulations, methodology and concepts in Patient Safety, and assess the impact of these to anticipate future developments in order for Kyverna to remain current and compliant.
- Maintain a vibrant external network of contacts in the fields of Patient Safety and clinical development and derive benefit for Kyverna from collaboration across this network in terms of deepened knowledge, sharing best practices and external perception of the company.
Requirements:
- 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 oriented.
- 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 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.