Andreas Ayukebi

Senior Medical Director

Morges, Switzerland

Experience

Jan 2023 - Present
2 years 7 months
Switzerland

Senior Medical Director

Biogen International

  • 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.
Mar 2022 - Dec 2022
10 months
Switzerland

Global Medical Lead (G&L - Freelancer)

Bayer Schweiz

  • Global Medical Affairs – Oncology-Prostate Cancer
  • Managed a team of medical writers and editors to deliver high-quality medical communications services to Oncology products.
  • Provided medical support and assisted in global development and Reg strategy for LCM of the marketed Product
  • Provided strategic guidance and medical leadership of the global clinical development activities
  • Provided medical advice for all study types, planned and conducted under the responsibility of GMA Organization
  • Provided Drug Safety, Pharmacovigilance (PV) activities, reviewed & provided the company's perspective related to product safety profile in DSUR, and medical Information.
  • Supported Global Medical Affairs for Prostate Cancer through participating in MCT and ensuring alignment with the Medical Affairs Oncology regional and global team
  • Reviewed protocol deviations specifications for major and minor issues, edit check & raise queries
  • Answering study sites' medical questions and procedures on safety-related concerns
  • Responsible for Medical data review and writing medical review reports
  • Collaborate with statistician to provide study-related medical inputs on SAPs, draft and final CSR
  • Ensures proper conduct for Investigators Initiated Studies (IISs) and Non-Interventional Studies (NISs) before submissions for Global review
  • Address medical questions on the Protocol and as well as the interpretation of the protocol
  • Reviewed potential data, table, listing/graph (TLFS) for interpretation and presentation of scientific data
  • Reviewed and provided inputs on medical review plan and medical monitoring plan development
  • Provided support for interaction with third parties involved in Clinical development activities and outsourced activities, such as KOLs, CROs, and medical writers, as required
  • Provided input and reviewed draft versions of eCRF
  • Attends Global Core Team Meetings and provides medical support
Mar 2019 - Feb 2022
3 years
Saint-Prex, Switzerland

Senior Medical Director

Ferring International

  • 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.
Apr 2016 - Feb 2019
2 years 11 months
Basel, Switzerland

Associate PD Medical Director

Hoffmann La Roche (FL-Hays)

  • Translational Medicine (Early Dev.– Phase I/II) – Paediatric Oncology/Haematology
  • Worked in a cross-functional Translational Medical team, with key member functions of Scientific and Development teams during preclinical and early clinical development, and contributed as a medical expert to the implementation of translational strategy for the projects.
  • Responsible for implementing studies during the Proof-of-Concept phase by providing medical and scientific leadership and expertise to all lines of therapies.
  • Provided medical consultation to team members and answered all study-related medical questions. To ensure that the medical content is accurate and complete
  • Worked as an integrated part of the Translational Medical team to develop the overall clinical strategy for pre-clinical pipeline products
  • Key responsible for the medical strategy related to First-in-Human (FiH)/Other phase I/II clinical programs
  • Provided medical expertise to the team’s translational capabilities through preclinical development to FiH/Phase I trials and efficacy proof-of-concept (ePOC)
  • Medical responsible for the development of new protocols and contributing to key documentation (including regulatory documents) and presentations for projects moving through internal review and regulatory submissions
  • As a Translational Medicine Physician, supported the path into clinical development and represented the medical department in the company’s early clinical phase Core teams
  • Collaborated with Corporate Drug Safety to ensure medical oversight in FiH/Phase I/II clinical trials
  • Selection and engagement of international, external collaborators/KOLs to guide the medical strategy across the discovery-development continuum
  • Integrate knowledge to inform translational hypothesis generation. Contribute to data analysis obtained in pre-clinical studies and perform risk evaluations
  • Involved in identifying and reviewing new target proposals
Sep 2013 - Apr 2016
2 years 8 months
Bern, Switzerland

Research Physician (PI/Sub-PI)

University Hospital (Inselspital)

  • 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
Oct 2009 - Aug 2013
3 years 11 months
Basel, Switzerland

Global Clinical Trial Head

Novartis Pharma

  • Translational Medicine Unit
  • Provided cross-functional leadership to establish an integrated view of respective translational functions and expertise
  • Led the translational strategies for the clinical development of oncology programs
  • Developed and executed the biomarker strategies from Phase 1/II to licensure in alignment with Novartis' clinical development objectives
  • Bridged preclinical experimental data to translational strategies in assigned programs to deeply integrate the mechanism of action into the clinical development plan (target engagement, pharmacodynamics endpoints, patient selection) and correlate with clinical outcomes
  • Provided scientific, technological, and strategic guidance, and hands-on contributions to biomarker programs accompanying clinical trials to drive the company´s R&D programs, including CDx development
  • Coordinated biomarker-related program activities with internal and external stakeholders and drove integration of services, technologies, and capabilities to ensure achievement of program goals
  • Provided state-of-the-art biomarker input in regulatory documents (clinical study reports, IND, BLA documentation) Analyzed, interpreted, and presented clinical biomarker data to draw scientifically valid conclusions that support and enable decision-making
  • Worked with cross-functional teams (clinical, regulatory, diagnostics, preclinical) to ensure the key definitions in clinical translational steps agree with clinical development and regulatory approvals
  • Accountable for strengthening the interfaces, processes, and approaches across functions and teams within Novartis and strives for continuous improvement and acceleration
Apr 2008 - Nov 2009
1 year 8 months
Munich, Germany

Manager Clinical Dev. and Drug Safety/PV

PARI Pharma

  • 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
May 2005 - Mar 2008
2 years 11 months
Mannheim, Germany

Senior Clinical Project Manager

PRA GmbA

  • Managed national and multinational clinical trials with innovative vaccines in the field of oncology, infectious diseases, Neurovascular (Alzheimer, Parkinson), and many others
  • Ensure adherence to timelines, quality, and regulatory requirements in cooperation with the Clinical Project Team
Apr 2004 - Apr 2005
1 year 1 month
Essen, Germany

Clinical Scientist / Medical Monitoring

IFE GmbH

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

Summary

As a highly experienced Medical Director, I bring over 18 years of successful experience in leading medical communications, providing medical and operational expertise to the teams to deliver impactful and competitive development and unmet therapeutic areas. With expertise in Oncology/Haematology/Immunology/Neurosciences/Cardiovascular/Infectious/Pulmonary diseases communications and publication strategies, with thorough engagements with KOLs and stakeholders, I have a proven track record of enhancing brand visibility and engagement within large-scale accounts. Recognized for my strategic thinking abilities, effective communication skills, and collaborative leadership style, I am committed to effectively translating complex medical information into clear and compelling communications.

Languages

English
Native
German
Advanced
French
Elementary

Education

Jan 2003 - Jan 2004

Mibeg-Institute of Medicine

Clinical and Epidemiological Studies · Cologne, Germany

Jan 2001 - Jan 2003

Bedford University

PhD · Environmental Biology and Diseases Control · United Kingdom

Jan 1990 - Jan 2000

University of Hertfordshire

Doctorate Degree in Medicine · Medicine · Hartfield, United Kingdom

Certifications & licenses

Leadership

Publication Planning

Management

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