Basel, Basel, Switzerland
Inspiring and compassionate leader, recognized for overcoming challenges to implement innovative efficiency enhancements. Exceptional contributor with consistent delivery of high-quality results. Extensive background spanning clinical medicine, global patient safety, scientific communication, and medical affairs across roles in the UK, Spain, and the Czech Republic, as well as remotely on a US-headquartered global team. Strong medical and scientific acumen across oncology, haemato-oncology, and general medicine therapeutic areas. Skilled influencer with the resilience to drive complex projects to successful completion.
Accountable for safety strategy and clinical safety content for three investigational products in all phases of development including marketing application submission and defense activities, safety contribution to target product profiles, go/no-go criteria, guidelines for toxicity management, leadership of activities related to important new safety information and urgent safety measures, and safety input to preparation of phase 1-3 studies across indications and combinations, development and maintenance of safety information, identification and characterization of safety risks, and internal governance and health authority interactions. Line manages, trains, and develops competencies of patient safety physicians and scientists who are responsible for the implementation of safety strategy at product and study levels. Subject matter expert for initiatives enhancing efficiency and transforming ways of working across AZ Patient Safety: Next Generation Submissions and Patient Safety Strategic Solution.
Achieved the highest possible performance evaluation—Exceptional Contributions—in 2024. Received nearly 30 awards for leadership, innovation, process improvements, cross-functional collaboration, and excellent communication skills in 1 year. Provided proactive product level support of up to 21 phase 1-3 clinical studies across 9 oncology indications testing datopotamab deruxtecan (Dato-DXd) in monotherapy and combinations. As the Safety Lead for Dato-DXd Pan-tumour Global Product Team represented Global Patient Safety on cross-functional matrix and project teams. Spearheaded the development of safety target product profiles for new combination therapies in new indications and successfully presented them to senior leadership and governance committees. Nominated for 2024 AstraZeneca R&D Award for leading a cross-functional team that created a Clinical Safety Data Aggregation and Visual Analytics Platform. The innovative tool was described as transforming the efficiency of activities such as clinical safety surveillance and ADR determination and revolutionizing clinical safety by enabling fast comprehensive insights and clear visual presentation. Increased Dato-DXd safety surveillance efficiency through leading, coaching, and mentoring matrix team members, simplifying and clarifying processes and documentation. Led a cross-functional workstream for Dato-DXd-induced stomatitis safety strategy. Reduced stomatitis incidence and severity in a pilot study. Prepared the first Dato-DXd Clinical Safety Data Pooling Strategy Charter. Presented scientific topics at educational meetings. Spearheaded a global AI-focused team building.
Transitioned to Global Patient Safety as a successful participant in a highly competitive R&D career development programme. Recognised with multiple internal awards for inspiring and compassionate leadership, communication skills, delivering high-quality results within tight timelines, innovative ideas, and strong scientific and medical acumen. Gained experience in clinical development and post-marketing pharmacovigilance activities. Contributed to twelve product teams, including blinatumomab (CD3/CD19 BiTE), sotorasib (KRASi, oncology) and olpasiran (siRNA, cardiology). Lead author and project manager of multiple product PBRERs. Led and contributed to safety strategy, surveillance, signal detection and assessments, safety component of licence renewal document, risk management plan, core structured benefit-risk assessment, study protocols and reports, informed consent forms, DSUR, EU/UK RSI, IB, answers to health authority questions, and health hazard assessments. Successfully initiated and led a project to create the first Amgen web-based spontaneous adverse event reporting portal for patients and healthcare professionals. Mentored career development program participants and contributed to a “Women Empowered to be Exceptional” mentoring workstream.
Consistently evaluated as a top performer at scientific support of educational activities in cardiology, nephrology, osteology, inflammation, immuno-oncology, and haemato-oncology with expert skills in clinical and scientific literature data analysis, interpretation, and presentation. Led the process of scientific publications. Led inspection readiness and preparation to support audits and inspections. Trained staff on compliant scientific communication and departmental processes.
Planned and led a successful pre-launch educational and knowledge exchange programme for haemato-oncology healthcare professionals demonstrating long-term strategic and tactical thinking. Perfected skills at verbal and written communication and internal and external influencing. Presented scientific content to internal and external stakeholders. Supported clinical development, feasibility, and site selection. Trained staff on medical and scientific topics.