freiberufler Drug Development Consultant (Program Management, Clinical Trial Management) auf freelance.de

Drug Development Consultant (Program Management, Clinical Trial Management)

offline
  • auf Anfrage
  • 79219 Staufen im Breisgau
  • Weltweit
  • de  |  en
  • 02.04.2020

Kurzvorstellung

25 years experience in the pharmaceutical/biotech industry and CRO in clinical drug development in a broad range of indications/therapeutic areas
Expertise in strategic planning of global drug development programs and operational execution.

Qualifikationen

  • Compliance management
  • F&E Management
  • GxP
  • Klinische Studie
  • Krisenmanagement
  • Medizinforschung
  • Pharmaforschung
  • Projektleitung / Teamleitung
  • Projektmanagement
  • Qualitätsmanagement (allg.)

Projekt‐ & Berufserfahrung

Managing Director & Head of Clinical Development (Festanstellung)
IgNova GmbH, Oberursel/Taunus
1/2015 – 12/2019 (5 Jahre)
Life Sciences
Tätigkeitszeitraum

1/2015 – 12/2019

Tätigkeitsbeschreibung

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)

Eingesetzte Qualifikationen

Budgetierung, Controlling, Finanzplanung, Regulatory Affairs Management, F&E Management, Klinische Studie, Medizinforschung, Pharmaforschung, GxP, Personalentwicklung, Personalführung, Programm Management, Projektmanagement, Projektsteuerung (Projektcontrolling), Qualitätsmanagement (allg.), Qualitätsrichtlinien, Qualitätssicherungssysteme, Business Plan, Mergers / Acquisitions, Unternehmensphilosophie, Unternehmensstrategie, Unternehmensstruktur, Unternehmenszielsetzung

Head of Global Clinical Research (Festanstellung)
Biologische Heilmittel Heel, Baden-Baden
7/2009 – 12/2014 (5 Jahre, 6 Monate)
Life Sciences
Tätigkeitszeitraum

7/2009 – 12/2014

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

F&E Management, Klinische Studie, Pharmaforschung, Naturheilkunde, Risikomanagement, Personalführung, Qualitätsmanagement (allg.), Unternehmensstrategie, Vertragsmanagement

Director Clinical Development (Festanstellung)
Newron Pharmaceuticals SA, Basel
1/2008 – 6/2009 (1 Jahr, 6 Monate)
Life Sciences
Tätigkeitszeitraum

1/2008 – 6/2009

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

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

Quality Improvement Manager (Festanstellung)
UCB, Belgien
9/2007 – 12/2007 (4 Monate)
Life Sciences
Tätigkeitszeitraum

9/2007 – 12/2007

Tätigkeitsbeschreibung

Scope
• Reduce compliance risk by managing cross-functional and/or multi-site large-scale improvement projects in full cooperation with the key stakeholders and the UCB Quality Council
• Perform crisis and change management after the merger in areas of high risk to stabilize the processes and structures within the organization
• This includes project management, planning and coordination, problem analysis, project solution design and implementation, tracking and debugging, drive communication and management of change

Major Accountabilities
• Work as an internal consultant to ensure successful on-time delivery of quality improvement projects and/or identified change management actions with significant business impact

Eingesetzte Qualifikationen

Supply-Chain-Management (SCM), Kostensenkungs-Programm, GxP, Change Management, Compliance management, Projektmanagement - Audits, Projektmanagement - Kommunikation, Projektmanagement - Krisenmanagement, Projektmanagement - Risikomanagement, Qualitätsmanagement (allg.)

Senior Clinical Trial Manager (Festanstellung)
Schwarz BioSciences GmbH, Monheim
2/2001 – 8/2007 (6 Jahre, 7 Monate)
Life Sciences
Tätigkeitszeitraum

2/2001 – 8/2007

Tätigkeitsbeschreibung

Scope
• Responsible for assigned neurological projects (Clinical Sub-Team Leader) including
- a program of 2 global phase 2 trials in Epilepsy
- a program of 6 EU and US trials (Phase 2-3) in Restless Legs Syndrome
- a program of 2 Asian trials (Phase 3 & 3b) in Parkinson´s Disease

Major Accountabilities
• Develop, maintain and execute the Clinical Development Plan (CDP) and the respective clinical trials for phase II-IIIb together with Clinical Program Director and other members of the clinical sub-team
• Responsible for vendor selection (Master Service Agreement and work order negotiations, definition of scope of work, timelines, KPIs and milestone payments)
• Support the rotigotine (dopamine agonist) submission to the FDA (USA) and EMA (Europe) in the indications “Parkinson´s Disease and Restless Legs Syndrome”
• Planning of the RLS phase 3b program in close cooperation with Global Medical Affairs to support product launch in Europe & USA
• Line Management of clinical staff (Trial Managers, Clinical Research Associates, Clinical Trial Assistance)

Eingesetzte Qualifikationen

Forschung & Entwicklung (allg.), Klinische Studie, Medizinforschung, Pharmaforschung, Good clinical practice (GCP), Neurologie, Psychiatrie, Programm Management, Projektleitung / Teamleitung, Qualitätsmanagement (allg.)

Clinical Project Manager (Festanstellung)
Hoffmann-La Roche, Grenzach-Whylen
10/1999 – 1/2001 (1 Jahr, 4 Monate)
Life Sciences
Tätigkeitszeitraum

10/1999 – 1/2001

Tätigkeitsbeschreibung

Scope
• Responsible for planning, execution and reporting of oncology trials (Herceptin, Xeloda, Mabthera) in EU
• Local trial management of global IV trials and phase 3b/IV marketing studies

Major Accountabilities
• Responsible for outsourcing strategy, CRO selection and contract negotiations
• Coaching of Medical Managers with respect to clinical research methodology

Eingesetzte Qualifikationen

F&E Management, Klinische Studie, Medizinforschung, Pharmaforschung, Good clinical practice (GCP), Onkologie, Projektmanagement, Projektsteuerung (Projektcontrolling), Prozesscoaching, Projektmanagement - Projekt-Training

Clinical Project Leader (Festanstellung)
Arbeits- und Forschungsgemeinschaft für Arzneimitt, Köln
11/1991 – 9/1999 (7 Jahre, 11 Monate)
Life Sciences
Tätigkeitszeitraum

11/1991 – 9/1999

Tätigkeitsbeschreibung

Scope
• Responsible lead for EU clinical projects (phase 2-4) in psychiatric and neurology disorders (e.g. Major Depression, Anxiety Disorders, Dementia, Parkinson´s Disease) from planning to execution and reporting

Major Accountabilities
• Preparation of budget proposals, participation in bid defence meetings and negotiation of contract terms and conditions with the sponsor
• Acting as primary contact for clients for all scientific and operational aspects during the course of the study
• Responsible lead for clinical project team to provide training, timelines and budgets

Eingesetzte Qualifikationen

Architekturvisualisierung, Buchhaltung, Budgetierung, Klinische Studie, Medizinforschung, Pharmaforschung, GxP, Personalführung, Projektmanagement, Projektmanagement - Vertragsmanagement, Projektsteuerung (Projektcontrolling)

Ausbildung

Psychologie
Promotion
1987
Universität Köln

Über mich

• Long-standing (> 25 years) professional R&D experience in the pharmaceutical industry in different executive positions, gained in big pharma (Roche), midsize (Schwarz BioSciences, UCB), small biopharmaceutical companies (Newron, IgNova) and a Clinical Research Organisation (AFA)
• Proven global drug development expertise and experience in management of clinical trials (Phase I-IV)
• Expert knowledge in CNS indications, psychometric rating scales, questionnaires and patient reported outcomes

Weitere Kenntnisse

GxP mit Fokus auf ICH/GCP und GVP, MS Office, MS Project

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
1985
Alter
64
Berufserfahrung
32 Jahre und 4 Monate (seit 11/1991)
Projektleitung
25 Jahre

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden