Germany
Passionate, motivational executive with more than 20 years of lead pharma responsibilities in Global, US and affiliate roles across all phases of drug development. Strong ability to combine business and medical strategy to drive overall performance. Extensive experience ranging from early stage drug development to post approval life-cycle management. Significant foundation in Global Medical Affairs. Broad disease area expertise within immunology, respiratory, ophthalmology, neuroscience and metabolism incl. rare diseases. Track record of developing, launching and driving market-shaping activities for biologics within multiple disease areas. In-depth practical experience with work in cancer patient associations. Proven strengths in motivating, leading and developing teams and individuals. Worked and lived in seven different countries and cultures with truly multicultural mindset.
Leadership and oversight of the following groups within the Medicine organization: Global Clinical Development, Clinical Development Operations, Regulatory Affairs, Quality Medicine, Biostatistics & Data Sciences, Pharmacovigilance & Patient Safety. Therapeutic Areas: Cardio-Renal-Metabolism/Inflammation/Respiratory/Oncology/Mental Health/Eye Health.
Led the Global Medical Neuroscience team with full accountability for the global medical and scientific strategy. Broad portfolio and pipeline within multiple sclerosis, neurodegeneration and neuropsychiatry incl rare disease. Accountable for all strategic and operational GMA programs, including medical affairs studies (interventional studies, NIS and RWE studies) and the planning & execution of the medical/scientific engagement strategy (MSL/Field Medical Affairs strategy, medical education programs, scientific publication planning and Medical Expert network development). Co-chair of franchise Integrated Scientific Review Committee reviewing and approving all global and local phase III-IV trials. Close collaboration with GPPS (Market Access and Commercial), regions and key markets to maximize the value proposition for the pipeline and portfolio. Key partner to the Global Drug Development organization, ensuring that the strategic alignment and input was embedded at all key development milestones and proactively updated when required.
Led the Global Medical Ophthalmology team with full accountability for the global medical and scientific strategy. Rich portfolio and pipeline covered diseases and conditions from front to back of the eye including biologics, gene therapy, small molecules and digital therapeutics. Accountable for all strategic and operational GMA programs, including medical affairs studies (interventional studies, NIS and RWE studies) and the planning & execution of the medical/scientific engagement strategy (MSL/Field Medical Affairs strategy, medical education programs, scientific publication planning and Medical Expert network development). Co-chair of franchise Integrated Scientific Review Committee reviewing and approving all global and local phase III-IV trials. Close collaboration with GPPS (Market Access and Commercial), regions and key markets to maximize the value proposition for the pipeline and portfolio. Key partner to the Global Drug Development organization, ensuring that the strategic alignment and input was embedded at all key development milestones and proactively updated when required.
•Headed up PRECISION, a global, pioneering severe asthma market-development program for biologics. The goal is to change clinical practice and improve patient access to biologics worldwide with special focus on US, EU5, Canada, Japan and Asia Pacific countries. •Led the global, cross-functional PRECISION team with accountability for the overall global strategy and local implementation including numerous innovative initiatives to change treatment pathways. •PRECISION was a multifaceted program involving >500 global and national respiratory experts from clinical practice, patient advocacy groups, the payor and policy environment, to accelerate patient referrals, build clinical capabilities, expand system capacity and evolve healthcare policies within Severe Asthma.
•Headed up the Medical, Safety & Regulatory Affairs function consisting of approx. 90 employees across seven countries (Sweden, Denmark, Norway, Finland, Estonia, Latvia and Lithuania). •Accountable for developing the local Medical strategy and Medical activities across all AZ disease areas including global real word evidence generation and phase III/IV studies. •Accountable for regulatory activities, patient safety, market ethical sign off as well as compliance activities in relation to GXP requirements. •Member of the Global Medical Affairs Counsel consisting of key stakeholders from Global Medical Affairs and Medical Directors in key markets.
•Spearheaded the development and implementation of the global Actemra medical strategy bridging clinical development to medical practice. • People Management (Medical Managers). •Headed up the International Medical team – a matrix team with around 26 members. •Headed up a matrix team responsible for evaluation and approval of investigator initiated studies. •Medical stakeholder in the Lifecycle Management Strategy Team and International Business Team. •Close cross functional collaboration with key functions including Development, Safety, Regulatory and Marketing. •Medical Affairs Lead of the global brand publication strategy. •Headed up phase phase IIIB/IV trials (including umbrella design). •Lead on medical education initiatives. •Close collaboration with Therapeutic Area Experts within the field of autoimmune diseases.
•Responsible for the development and implementation of the MabThera medical strategy bridging clinical development to medical practice. •People Management •Headed up the International Medical team – a matrix team with around 12 members. •Close cross functional collaboration with key functions including Development, Safety, Regulatory and Marketing. •Member of the Lifecycle Team. •Member of the International Business Team. •Representing Medical Affairs for the global brand publication strategy. •Medical lead of phase IV trials. •Medical lead for evaluation and approval of investigator initiated studies. •Lead on medical education initiatives. •Launch of MabThera in MPA/GPA •Close collaboration with Therapeutic Area Experts within the field of autoimmune diseases. •In depth experience in Biosimilar Strategy •Close collaboration with the Mabthera Oncology team on medical strategy, safety and regulatory matters.
•Group Manager of a unit responsible for identifying, evaluating and recommending research centers of excellence for partnership in the Novo Nordisk clinical trial program in the US and Canada. •Key role in managing and expanding strategic partnerships and engaging Therapeutic Area Experts more actively in research activities. •Medical lead and oversight of phase III trial programs within the field of diabetes and other endocrine diseases within the US and Canada. •Medical lead oversight of early phase trials (Phase I/II) within the field of autoimmune diseases. •Pre-launch activities •Close collaboration with Therapeutic Area Experts within the fields of diabetes, other endocrine diseases and autoimmune diseases.