Senior Medical Director

• Global Medical Affairs – Neurovascular/Neurodegenerative Diseases (Alzheimer, Parkinson, MS, Ischemic stroke, Brain contusion/Cerebral Edema, Brain injury)
• Led and supervised the development of publication content within a large neurodegenerative disease, increasing scientific impact and brand visibility.
• Collaborated with an international team and account to ensure the accuracy and effectiveness of medical communications materials.
• Oversaw the strategic planning and execution of key attendance at conferences, resulting in increased engagement with healthcare professionals
• Contributed to Global Medical Affairs strategies, policies, and programs, and drove implementation in the international region
• Support the launch of new and marketed products by generating and disseminating scientific and clinical evidence, both internally and towards key external stakeholders
• Responsible for Investigators Initiated Studies (IISs) and Non-Interventional Studies (NISs)
• Established and managed relationships with relevant KOLs, influencers, societies, associations, and prescribers, and facilitated appropriate contacts across the region
• Developed, coordinated, and conducted external education and training for MDs, caregivers and patients, and customer support groups in line with the Medical Affairs plan
• Provided expertise in the evaluation of complaints and adverse events
• Worked closely with Public Affairs to align scientific and medical society support for patient advocacy initiatives
• Educate the internal Shire community through partnering on content development and delivery of medical training, and ensuring field teams have the clinical knowledge to effectively support the therapy at a local level
• Provided Medical input to Marketing and product launches
• Worked with International GBU and Therapy Advisory Board to develop the network of local country Shire MD`s in the therapeutic area /business, leveraging best practices and expertise across the region, and provided medical input into product launches
• Provide expertise on neurovascular protocol review to support global studies and programs.
• Developed medical strategies for the study protocol and supported medical affairs initiatives.
• Responsible for the promotional and scientific materials, review, and approval
• Lead CCSM team engagements with clinical sites for therapeutic programs.
• Conduct protocol training for CCSLs in assigned Phase II/III/IV studies.
• Integrate and align clinician engagement strategies with therapeutic programs.
• Serves as an escalation point for clinical/medical protocol issues.
• Collaborate on multi-year global medical strategy aligned with product/R&D strategies.
• Managed safety data review, signal detection, and communication across development phases.

• Global Medical Affairs – Oncology/Gastro-(IVDMD and IVDR)
• Executed and managed medical communications and provided clinical and scientific expertise to support all aspects of the international Lung Cancer and IBD business.
• Leads and supported international Medical Affairs activities before, during, and after product Launches
• Provided input and expertise to the Global Product Development team and Lifecycle strategy development
• Leads team to ensure delivery of key Medical Affairs activities for Launch readiness plans globally, scientific communication strategy, and content/SDD/Slide/Kits/FAQs, External Engagement, and medical review of promotional materials
• Leads medical peers and cross-functional support team to execute all key medical affairs deliverables in alignment with strategy
• Overseeing the planning of symposia, advisory board meetings, and other meetings with KOLs and healthcare professionals
• Supervised team`s attendance and scientific congress support
• Creates a collaborative, team-oriented environment and ensures appropriate development of team members
• Contributed to the development of scientific content for medical education programs and promotional materials.
• Managed global Medical Affairs for oncology and gastroenterology studies, including Phase IIIB-IV, PMS, and observational studies.
• Implemented strategic plans for medical education and data generation for publications and conferences.
• Developed and executed post-marketing clinical trials and real-world data studies to support evidence-based strategies.
• Collaborated with cross-functional teams to develop medical strategy, regulatory submissions, and scientific communication.
• Built high-quality relationships with stakeholders, ensuring medical inquiries received updated scientific information.

• Department of Visceral Surgery and Medicine – Gastro-Hepatology (IVDMD and IVDR)
• Provided expertise in medical and clinical insights to inform the effective development of the Gastroenterology and Hepatology medical strategy through internal and external engagements, while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives
• Led clinical research projects in gastroenterology and hepatology
• Developed and maintained CERs for Class III medical devices
• Ensured adherence to MDR and ISO13485:2016 standards
• Reviewed medical data and wrote review reports
• Provided GCP training and mentored study team members
• Managed resources, budgets, and ethics submissions
• Good understanding of EU Medical Device regulations for both Medical Device (MDD) and In-vitro diagnostic Medical Device (IVDMD)
• Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary by 21 CFR Part 803.
• Good understanding of Medical Device classifications

• Medical Device and Drug Development – Pulmonary Diseases (IVDMD and IVDR)
• Responsible for supporting the Pharmacovigilance (PV) and Medical Monitoring (MM) operations during clinical program implementation, clinical study start-up, execution, closeout, data collection and analysis, as well as reporting and supporting of regulatory filings of clinical trials in various pulmonary disease indications.
• Prepared and organized safety review meetings, presented relevant safety events, and compiled meeting minutes.
• Contributed to the development, maintenance, and implementation of controlled documents like SOPs and other process documents for clinical trials.
• Analysed safety-related data in the eCRF or listings extracted from databases to identify relevant safety events and to support data reconciliation.
• Developed and wrote narratives of significant adverse events by regulatory requirements.
• Ensure processes for PV and Safety Reporting are implemented and executed consistently throughout clinical studies.
• Supported the collection of safety reports from clinical trials and collaborated with other departments (Clinical Operations, Medical Department, Data Management, Medical Writing, Regulatory) to ensure consistency with regulations and departmental goals and objectives.
• Good understanding of EU Medical Device regulations for both Medical Device (MDD) and In-vitro diagnostic Medical Device (IVDMD)
• Evaluate complaints to determine whether an investigation in necessary and if Medical Device Reporting (MDR) is necessary by 21 CFR Part 803.
• Good understanding of Medical Device classifications

Led and supported different studies, depending on size/complexity. Led and was accountable for the clinical/scientific execution of the protocol.