Petra Dirks

• Global Evidence Lead Ocrelizumab: Built and lead a multi-functional team to create an evidence generation strategy to address data gaps of different stakeholders and support the commercialization of ocrelizumab, which resulted in the integrated evidence plan (iEP) for Ocrevus SC launch activities and guidelines for >25 affiliates when supporting investigator initiated studies
• Co-lead of the Disease Area iEP team: Tailored the development of a multi-functional team to align and create synergies across evidence generation at different stages of the product development and maximize the value of investments. Organize workshops for the identification of evidence gaps and corresponding solutions.
• Scientific Lead of the phase IIIb LIBERTO study (NCT03599245): Supervised medical monitoring activities, review and approve study-specific documents such as protocol amendments, statistical analysis plan, patient narratives, clinical study report, lay clinical trial description, present data at steering committee meetings and scientific congresses. Publication of data in peer-reviewed journals (under preparation)
• Insight Generation: Built an COVID-19 advisory committee composed of KOLs with different expertise, coordinated the execution of advisory boards to gain insight into the impact of the pandemic on the medical care of multiple sclerosis patients, which resulted in the development of an evidence generation and communication plan
• Further responsibilities: contribute to work packages of different topics (e.g. KOL engagement, integrated Strategy Plan), review promotional materials in consideration of compliance guidelines, attend scientific congresses to represent the company and built network with top KOLs

• Responsibilities focused on medical activities to ensure a successful ocrelizumab launch in Germany
• Scientific Lead of the phase IV CONFIDENCE PASS (EUPAS22951): Developed with the participation of an international team the study design and protocol to fulfill multiple ocrelizumab post marketing authorizations / regulatory commitments which resulted in an aligned data collection with other external data sources (registries) in order to provide large scale data sets for long-term safety data analysis. The study recruited >2500 multiple sclerosis patients newly treated with ocrelizumab and delivered already a variety of safety and effectiveness data supporting the use of ocrelizumab in clinical practice. Data have been presented at local and international congresses as well as in peer-reviewed journals.
• Collaborated with the Market Access Team in the preparation of the ocrelizumab value dossier, written statements and GBA oral hearing
• Drove the country specific ocrelizumab medical launch plan aligned with the global strategy
• Represented the medical team in multi-functional brand team meetings
• Educated sales representatives / MSLs on the latest ocrelizumab data and developed content for medical symposia at national neurological congresses to ensure a high-quality and compliant scientific exchange with healthcare professionals and other stakeholders
• Reviewed and approved promotional materials in consideration of local compliance guidelines

• Implemented and executed medical pre-launch activities supporting the successful launch of Tecfidera
• Responded to inquiries from health care professionals and KOLs immediately, ensuring the safe and appropriate use of disease modifying therapies
• Generated insights from the field to inform internal medical and marketing functions in developing evidence generation and communication strategies
• Identified experts according to their medical expertise and academic reputation
• Coordinated advisory boards and meetings with external stakeholders to better understand needs and address concerns.
• Prepared presentations for scientific meetings or educational efforts
• Overseen investigator initiated trials which resulted in the adherence to predefined study milestones and publication of data informing the clinical use of disease modifying therapies
• 05/2015 - 10/2015: Biogen, Cambridge MA, United States, Short-term assignment in the Neurology Discovery Group which resulted in a better understanding of global needs for evidence generation

• Created professional sales presentations and seminars to effectively demonstrate product features and competitive advantages, which resulted in a successful launch and broadly use of the first Erythropoetin biosimilar. Sales targets were always achieved or exceeded.
• Trained and mentored new sales representatives.
• Gathered insights on customer needs and educational requirements

Employed by the following customers:

• MEDICE Arzneimittel Pütter GmbH & Co.KG, Iserlohn, Germany (Indication area: Nephrology)
• Sanofi-Aventis GmbH, Berlin, Germany (Indication area: cardiovascular diseases)

• Headed molecular biological projects in the research group neurobiology focusing on the functional and molecular characterization of electrical synapsis in the retina
• Published manuscripts in peer-reviewed journals, presented data at scientific congresses