Executive Medical Director / Medical Affairs Experte für Strategieentwicklung & Umsetzung, >20 Jahre Erfahrung

9/2019 – 10/2020

Development and leadership of the global Medical Affairs plan for incorporation into regional and in country medical affairs plans Leadership of

o Global SWOT and strategic imperatives for metreleptin and the global medical affairs plan for activities to be supported at an above country level
o Global medical advisory boards to gather expert advice and incorporate into strategies and plans
o Company planned activities such as key congresses including speaker selection, lecture topics, briefing and key message delivery

F&E Management, Klinische Forschung, Drug Discovery, Medizinische Versorgung, Gute Klinische Praxis, Humanmedizin, Kindermedizin, Medizin, Swot-Analyse

4/2019 – 8/2019

Leadership of the EMEA Medical Affairs plan for metreleptin
Line management of Medical Directors / medical staff within Europe, Middle East and Africa
Preparation and execution of the lipodystrophy disease awareness campaign to position lipodystrophy as a complex and potentially life-threatening disease and to position Myalepta® as the first approved and the only causal therapeutic option for lipodystrophy
Leadership of EMEA SWOT and strategic imperatives for metreleptin in collaboration with commercial, marketing and market access
Medical leadership and operational support for European Medicines Agency (EMA) post approval commitments
Drug registry in collaboration with the ECLip registry (establish partnership with academia) o Immunogenicity program o Partial lipodystrophy study
Generation of supportive data for metreleptin to ensure positioning of the drug  Leadership of patient advocacy activities / support of establishment of new patient advocacy groups within EMEA
Establishment and leadership of the lifecycle management plan for metreleptin (non-alcoholic liver disease (NASH), congenital leptin deficiency (CLD; NHS England Clinical Commissioning Policy), hyperactive anorexia nervosa, new application routes/devices, etc.)

Betriebliches Gesundheitsmanagement

1/2017 – 8/2020

Targeting based on the patient journey and including KOL selection, development, and management with special focus on Germany
Key medical specialties: endocrinologists and paediatricians
Additional medical specialties important for the diagnose of the disease: dermatologists, gynaecologists, hepatologists, diabetologists, lipidologists
Establishment of a lipodystrophy centre of excellence structure in Germany (national and regional centres) and strengthening of the referral process
Establishment of medical affairs structure including field support by medical scientific liaison managers (MSLs)
Increase disease awareness for lipodystrophy, a rare disease (development of medical / scientific materials for media, conferences, and MSLs; development of a disease website for lipodystrophy; presentations / development of product website / trainings (disease and product) for HCPs)
Launch preparation for Myalepta®, a leptin replacement therapy in Germany (launch symposium, new detail aid, PR activities, scientific publications)  Approval of Myalepta by EMA
Successful G-BA (federal joint committee, gemeinsamer Bundesauschuss) scientific advice
Favourable G-BA benefit assessment for metreleptin o Non-quantifiable benefit for both indications, partial and generalized lipodystrophy
Launch of Myalepta (metreleptin) in Germany as the first country in Europe  Prosperous outcome (<18% price reduction) of the pricing negotiation with the national association of statutory health insurance funds (GKV-SV, Spitzenverband der gesetzlichen Krankenversicherungen)
Meeting with the Austrian Hauptverband to discuss launch in Austria / preparation of value dossier for Austria
Support global organization especially in market access including preparation of the global metreleptin value dossier and scientific advise meetings with key regulatory and HTA bodies

Drug Discovery, Humanmedizin, Kindermedizin, Markteintrittsstrategien

1/2017 – 8/2020

Targeting based on the patient journey and including KOL selection, development, and management with special focus on Germany
Key medical specialties: endocrinologists and paediatricians
Additional medical specialties important for the diagnose of the disease: dermatologists, gynaecologists, hepatologists, diabetologists, lipidologists
Establishment of a lipodystrophy centre of excellence structure in Germany (national and regional centres) and strengthening of the referral process
Establishment of medical affairs structure including field support by medical scientific liaison managers (MSLs)
Increase disease awareness for lipodystrophy, a rare disease (development of medical / scientific materials for media, conferences, and MSLs; development of a disease website for lipodystrophy; presentations / development of product website / trainings (disease and product) for HCPs)
Launch preparation for Myalepta®, a leptin replacement therapy in Germany (launch symposium, new detail aid, PR activities, scientific publications)  Approval of Myalepta by EMA
Successful G-BA (federal joint committee, gemeinsamer Bundesauschuss) scientific advice
Favourable G-BA benefit assessment for metreleptin o Non-quantifiable benefit for both indications, partial and generalized lipodystrophy
Launch of Myalepta (metreleptin) in Germany as the first country in Europe  Prosperous outcome (<18% price reduction) of the pricing negotiation with the national association of statutory health insurance funds (GKV-SV, Spitzenverband der gesetzlichen Krankenversicherungen)
Meeting with the Austrian Hauptverband to discuss launch in Austria / preparation of value dossier for Austria
Support global organization especially in market access including preparation of the global metreleptin value dossier and scientific advise meetings with key regulatory and HTA bodies

Drug Discovery

1/2015 – offen

Board Level Director with a broad base of research & development, medical affairs, marketing, and commercial experience, in large and medium sized pharmaceutical companies on a regional and global level, including many years of P&L responsibility

Board membership
Development and review of (global) company strategy
Interim management / marketing, medical, medical affairs, patient advocacy & scientific leadership


Clinical, medical affairs & regulatory strategy development and review on a global, regional and country level
Develop relationships especially in the rare disease space including key opinion leader, practicing clinicians, investigators, scientists, clinical societies and patient advocacy organizations
Establishment of disease awareness campaigns in rare diseases including drug & disease positioning
Selection and management of key congresses including symposia, scientific communication and medical education activities
Plan, execute and lead advisory boards to garner feedback on study design, clinical trial data, clinical experience, detail aids, positioning of the drug and the disease, disease awareness campaigns
Value dossier development & pricing/reimbursement negotiations focusing on key European markets
Restructuring of company organization

Strategische Unternehmensplanung, Unternehmensberatung, Strategisches Management, Unternehmensstrukturen

7/2013 – 12/2014

Establishment of the company in July 2013 in Wexham, UK
Architect / leader of the reorganization of the European R&D headquarters o Downsizing from slightly above 100 employees to 60 employees by focusing on key areas
All but one talent were retained o Execution according to plan (time and budget)
OEDC positioned as the key strategic partner for the marketing & sales organization (OFRI was a kind of an internal CRO mainly focusing on clinical development)
Ensured alignment with commercial Headquaters (Otsuka Pharmaceuticals Europe Ltd (OPEL))
Development & execution of European R&D strategy for the continuous success of Otsuka

Personalführung, Strategische Unternehmensplanung

10/2010 – 11/2014

Leader of the organizational changes  Approval of Abilify Maintena® (depot formulation) and Deltyba® (treatment of multi resistant tuberculosis)

Submission of Jinarc® (treatment of polycystic kidney disease

Provided European leadership in Otsuka’s global PV reform

Positive outcome of the Cilostazol referral (EMA)

Closure of MHRA PV inspection

Prepared – in line with the business reform of the European R&D headquarter - the liquidation of the company which started 01DEC-2014

Strategische Unternehmensplanung

10/2008 – 9/2010

Lead the global clinical development activities (mainly Phase II and III); main indications actinic keratosis, psoriasis, atopic dermatitis, rosacea, and onychomycosis

Selection, development and management of key opinion leaders

Establishment of contacts to Regulatory Authorities including scientific advise meetings

Development of clinical strategy for US market

Klinische Forschung, Medizinforschung

4/2005 – 9/2008

Head of the Medical Department (Clinical Operations, Medical Marketing, Training, and Drug Safety)
Qualified Person responsible for Pharmacovigilance in
Austria (Pharmakovigilanz-Verantwortlicher)
Germany (Stufenplanbeauftragter, §63a AMG)
Information Officer (Informationsbeauftragter, §74a AMG)

Main tasks and responsibilities:
Provide medical expertise in the therapeutic areas dermatology (main products: Daivobet®, Fucidine®), bone metabolism (EinsAlpha®), and clotting disorders (main products: Innohep® and ATryn®) to ensure that the overall medical team goals are coordinated with the medical, regulatory, and marketing strategy

Responsible for the clinical development strategy and the conduct of several clinical trials (Phase II – IV), mainly in the key dermatology areas psoriasis and atopic dermatitis but also in the indications disseminated intravascular coagulation (DIC) and thrombosis

Review and supervision of all aspects of clinical research and postmarketing clinical study programs. Organize and facilitate clinical results for regulatory submissions. Actively participate in and, as appropriate, lead development of strategies based on clinical data to maximize the commercial potential of the company’s products in adherence to both, company’s standards and government/industry regulations

Proactively identify and address potential medical issues and ensure implementation of risk management strategies

Direct the local publication strategy and supervise implementation.  Select, develop and manage key opinion leaders

Coordinate and lead scientific advisory boards

Oversee deployment and development of all managers in the medical department (9 direct reports)

Angewandte Forschung, Forschung & Entwicklung, Klinische Forschung

6/2002 – 4/2005

Launch preparation including generation of pre-licensing sales.
Set-up of the specific (scientific) sales force
Selection, development and management of key opinion leaders

Provide medical expertise in dermatology, oncology, immunology, transplantation, virology, hormone replacement therapy, asthma/allergy, and cardiovascular diseases
Project management of products/projects in development from the decision to develop in man to the submission decision point in the above mentioned therapeutic areas
Evaluation of in- and out-licensing opportunities
Representative of Germany in Region Europe

Medical input in the field of Dermatology and Asthma & Allergy in line with the marketing strategy and in close cooperation with clinical research & development
Lifecycle management activities, such as the initiation of phase IV studies and investigator initiated trials
Development and implementation of the generic defence strategy
Selection, development and management of key opinion leaders, leading the marketing advisory boards
Creation of new sales folders and other promotional material.
Organization of conferences and congresses including the briefing of scientific speakers, and contact to patient organizations, medical and scientific boards
Ad iterim product manager for a long-acting beta-2 agonist, a corticosteroid , and the Manager New Products for the Asthma & Allergy pipeline

Medical Writing, Medizinforschung