Current position and relevant professional experience:
Highly respected within the pharmaceutical industry and over the last three decades I have worked across a broad range of disciplines including process engineering, quality assurance, regulatory affairs, business development, and commercial operations management.
A graduate (BSc (Hons) Process Biotechnology) of the University of Teesside, I recently passed (with distinction) the Global Executive MBA at the Henley Business School. The EMBA involved consulting projects with established businesses, a technology start-up, and an NGO in Cape Town, South Africa.
Summary of professional experience:
August 2021 – Present
Vice President Advisory Practice, G&L Healthcare Advisors
Management consultancy and strategic advisory services including business transformation, organisational design/development, operational excellence, process/system mapping.
April 2021 – July 2021
Freelance Management Consultant, Reward 360 Consulting
May 2019 – April 2021
Vice President Global Geographic Expansion & General Manager, UK
BLUEREG Pharma Consulting
Commercial strategy for the organisation focused on global expansion of the business, marketing and communications and sales / business development.
General Manager UK, including Companies House Director for UK legal entity, HR strategy and day to day support, facilities, vendor management, legal and financial compliance for UK business (e.g. GDPR) including payroll, pensions, and benefits.
Aug 2017 – May 2019
Vice President Global BD & Marketing, GM UK - Voisin Consulting Life Sciences
Ownership of commercial function, with routine representation at Board level.
Restructured and developed commercial function, and set strategy to deliver twice the value of global contract sales across two financial cycles. Implemented commercial reporting structure including marketing, pipeline, and contract sales. Directed and focused marketing function towards commercial lead generation using mix of inbound and outbound, offline and digital strategies. Member of the VCLS Strategic Advisory Board.
General Manager UK, HR strategy focusing on recruitment, employment relations issues and GDPR within UK region, managed complete office refurbishment within budget and on time.
Jun 2015 - May 2017
GENPACT Pharmalink - Vice President Business Development
Commercial strategy design: go-to-market, account penetration and development. Business development primarily with European HQ pharma region (some US clients), delivered target $10 million bookings in first year, increased pipeline by 300%. Genpact’s Leadership Excellence Acceleration Program (LEAP), in top 10% of peer group. Genpact’s Global Business Leader Award in Consumer Goods, Retail and Life Sciences vertical.
3
Dec 2013 - Jun 2015
Head of UK (& European Ops) GENPACT Pharmalink (formerly Pharmalink)
Responsible for 65+ permanent staff and 50+ freelance consultants; Overall responsibility for projects and personnel with European Operations; Business development across a range of subject areas; Defining strategy and direction for the region within Global business plan; Training management, preparation and delivery on specific technical areas; Restructuring of Operations group in the UK; redefined job family architecture.
Oct 2008 – Dec 2013
Pharmalink Consulting Limited - Associate Director, UK Operations
Budget responsibility for projects to both Clients and Board of Directors; Technical expert for resource planning and costing within project tenders; Establishing service levels for individual regulatory projects; Lead advisor for client projects involving clinical trials and biotechnology; Oversight of remote regulatory projects including staff utilisation, profitability, workload smoothing; Technical training (and budget) within operations team.
Oct 2006 – Oct 2008
Pharmalink Consulting Inc - General Manager, North American Operations
Created start-up operation, structure and organisation - set-up and management of local operations as well as developing a new business and client base in a completely new market; Management of the day-to-day operations including project/staff recruitment, financial and contracts management, facilities and business development.
Mar 2004 – Sep 2006
Pharmalink Consulting Limited - Regulatory Affairs Manager, Operations
Direct line management; Implemented formalised annual appraisal system and monthly reporting for regulatory staff; Technical input to client proposals.
Aug 1999- Mar 2004
Senior Regulatory Project Manager - Janssen-Cilag Limited (J&J)
Manipulation of all aspects of MA through MRP/ National procedures with the UK / Irish Affiliate; Responsibility and line management CMC team; Product responsibilities include anti-fungals, EPO, leukaemia, and female health; Quality Assurance.
Current or previous involvement in TOPRA activities:
Biotech SPIN group committee, including organizing committee for Module 9 (Biotech) of the MSc Regulatory Affairs
Editorial Board Regulatory Rapporteur
Commercial support for the organization through sponsorship in multiple organizations
Contribution to Regulatory Rapporteur articles, published in the past 6 months.
Personal statement:
My varied experience within pharmaceuticals worldwide, over three decades, offers practical support for the business challenges TOPRA faces. A combination of regulatory, business and commercial management, and consulting presents something unique to this candidacy.
I am a Company Director, legal Trustee, FTOPRA, and member of the IOD, and RAPS. I have held legally accountable positions in the voluntary sector, and exposure to different member organizations, provides insight to practices and ideas benefitting TOPRA’s work and its members.
I have built a relationship with TOPRA staff, including Kevin Pay, over a long period of time so can hit the ground running.
Nomination information
Proposer: Lisa Toner; Seconders: Sandra Maguire, Rachel O’Kane