Drug Development Consultant (Program Management, Clinical Trial Management)

1/2015 – 12/2019

Scope
• Establishment of an effective and target oriented bio-pharmaceutical company
• Product development (galenic formulation, manufacturing, preclinical & clinical development) and market authorization in EU and USA
• Create concepts for strategic advancement and further business development and partnering

Major Accountabilities
• Prepare the business plan, determine and execute the overall company strategy
• Strategic planning (goals, milestones and decision points, budget, human resourcing)
• Preparation of the annual budget and budget tracking to monitor cost and investments
• Promote product development, patentability, market authorization and commercialization of the key development project IGN-ES-001(polyclonal IgY antibodies) and other pipeline projects based on the IgNova immunoglobulin technology platform
• As “Head of Clinical Development”: Elaboration and implementation of the Clinical Development Plan (CDP) and monitoring of all operational clinical activities to ensure Sponsor Oversight
• Define the regulatory strategy to obtain market authorization for IGN-ES-001 drug development project in EU and USA
• Establish the quality management system (QMS) with a cGMP-compliant manufacturing process to receive the manufacturing license
• Realization of an own IgNova manufacturing facility in close collaboration with a design office, plant constructors and CMOs to produce investigational medicinal products (IMPs) for clinical trials and later trading goods
• Exploration of patent opportunities based on the IgNova technology platform
• Perform merger & acquisition activities in the US and EU to gain a strategic partner from the pharmaceutical industry for late stage clinical development and subsequent commercialization of IgNova products
• Represent IgNova in professional associations and expert groups (networking & lobbying, e.g. BPI)

Budgetierung, Controlling, Finanzielle Planung, Regulatory Affairs, F&E Management, Klinische Forschung, Medizinforschung, Drug Discovery, GXP, Personalentwicklung, Personalführung, Programm-Management, Projektmanagement, Projektsteuerung (Projektcontrolling), Qualitätsmanagement (allg.), Qualitätsrichtlinien, Qualitätssicherungssysteme, Business Plan, Fusionen und Übernahmen, Unternehmensphilosophie, Strategisches Management, Unternehmensstrukturen, Unternehmenszielsetzung

7/2009 – 12/2014

Scope
• Overall responsibility for all clinical R&D and life-cycle management projects
• Shape the strategy of the department and lead the strategic planning of clinical R&D activities in close alignment with internal key stakeholders
• Budget planning and tracking

Major Accountabilities
• Elaborate the clinical research strategy, including timelines, budgets and proposed go/no-go decision criteria for specific projects
• Accountable for the state-of the-art planning, implementation and reporting of all clinical research projects
• Endorse a “quality culture” within the department and stimulate the development or improvement of business processes to obtain operational excellence with respect to proper clinical research project management
• Acting as line manger for all clinical project managers – solely responsible for allocation, supervision, coaching and mentoring, including definitions of annual goals and performance appraisal

F&E Management, Klinische Forschung, Drug Discovery, Naturheilkunde, Risikomanagement, Personalführung, Qualitätsmanagement (allg.), Strategisches Management, Vertragsmanagement

1/2008 – 6/2009

Scope
• Responsibility for all products from first dose in man to dossier approval and marketing (Phases I-IV)
• Oversee and manage one global clinical development program with one or more indications, or multiple regional development programs, from early development to regulatory approval and beyond, in order to achieve a high-quality product for the marketplace and business success for Newron

Major Accountabilities
• Accountable for implementation of the Clinical Development Plan (CDP) and clinical trial processes from inception to completion for one or more clinical programs
• Provide clinical expertise and help elaborate the clinical development strategy, budgets and proposed go/no-go decision criteria for clinical development programs
• Preparation and periodical update of the clinical development plans with the appropriate timelines and phase transitions
• Participate in IND and NDA/sNDA submission activities
• Managing and supervising of trial teams, interfacing with other departments, external consultants, scientific experts, and vendors as appropriate
• Play a key role in all outsourcing activities (definition of service requirements, CRO pre-selection, proposal assessment and bid defence meetings, CRO selection)
• Responsible for scope of work (SoW) and definition of CRO key performance indicators, contract and budget negotiations with CROs, including oversight and monitoring of CRO performances and budget tracking
• Acting as line manger for a team of clinical trial managers and clinical research scientists

F&E Management, Forschung & Entwicklung, Klinische Forschung, Medizinforschung, Drug Discovery, Programm-Management, Projektleitung / Teamleitung, Projektmanagement, Projektplanung / -vorbereitung, Projektsteuerung (Projektcontrolling), Qualitätsmanagement (allg.)