Innovative boutique consultancy offering bespoke services to the Pharma, Biotech, Medtech and Venture Capital sectors

Profile

I have worked in the pharmaceutical industry for over 35 years, undertaking global strategic and operational leadership roles supporting product development, launch, and life cycle management activities for a variety of small molecules, biologics, medical devices and medical technologies. Key strengths include: combining scientific product knowledge and clinical development expertise with commercial acumen; de-risking clinical development strategy and expediting operational delivery and study execution; identifying novel treatment approaches; procuring best-in-class clinical research resources to deliver accelerated clinical research programs in compliance with ICH-GCP and Regulatory Agency requirements; positioning data effectively for potential licensing partners; and nurturing relationships with in- and out-licensing partner companies, key opinion leaders and stakeholders to deliver returns on investment and to provide maximum value to shareholders.

Key skillsets & experience

  • Clinical Research & Development (phases I-IV)
  • Alliance Partnering
  • Business Development
  • Due Diligence
  • Change Management
  • Budgetary Management
  • Commercial Acumen
  • Negotiation
  • Procurement
  • Project Management
  • Strategic Planning
  • Regulatory Compliance
  • Publication Planning
  • Commercial launch planning
  • Medical Affairs and Life Cycle Management
  • Capital raising and investor relations

Selective highlights

  • Clinical Lead for Successful regulatory submissions, regulatory inspection hosting, label expansions and development of new indications.
  • Development and validation of novel FDA required patient reported outcome measurements
  • Participated in Advisory Committee meetings for first in class products
  • Business Development including due diligence reviews
  • Participated in investor and analyst meetings to raise capital
  • Clinical and development lead for Alliance partner governance activities
  • Orphan drug and medical device experience
  • Senior leadership positions held in global Pharma/Biotech and CRO organisations with line management, program management and enterprise wide responsibility

  • Professional Indemnity (PI) Insurance coverage available.

Therapeutic experience

Having spent the formative years of my career in the contract research sector I gained experience across all phases of clinical development and with a broad foundation of therapeutic experience including:

  • Oncology
  • CNS (neurology and psychiatry)
  • Cardiovascular
  • Anti-infectives (antibiotics, antivirals and antifungals)
  • Urology and men’s health
  • Women’s health
  • Endocrinology and metabolic disorders
  • Musculoskeletal and pain
  • Respiratory
  • Dermatology
  • Ophthalmology
  • Gastrointestinal
  • Anaesthesiology and ICU medicine
Since moving to a Sponsor company role in 2001, my therapeutic experience has become more specialized but again across all phases of clinical development and including life cycle management and line extension planning:

  • Orphan and rare diseases
  • Paediatrics
  • Anti-infectives
  • Urology
  • Endocrinology
  • Orthopedics including shoulder, hand, knee and podiatry
  • Dermatology and aesthetics
  • Pain management
  • Post surgical adhesions
  • Cardiovascular
  • Sexual medicine
  • Circadian neuroscience and sleep medicine
  • Medical devices

Curriculum Vitae

If you would like a copy of my CV, please enter your name and email address below and tap/click on ‘Send request’. Your copy will be automatically emailed to you. 

    Image: LinkedIn You’ll also find my LinkedIn profile here.

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