Management
Ten executives, including the Managing Director, constitute the executive management team of CLINUVEL.
As Managing Director, Dr Wolgen sees his role as the conductor of the orchestra – keeping rhythm and discipline while ensuring the best possible ensemble is in place to do justice to the ‘score’. As the complexity of the business increases, it is imperative to have the right people in place for the multitude of tasks ahead, and the executive team is expected to grow accordingly. The executive team has and will become more visible as they communicate their activities and outcomes to stakeholders.
“The investor relations team loves telling CLINUVEL's dynamic story to stakeholders, particularly assisting new shareholders to discover the long-term incremental value being built.”
Malcolm Bull
- Head of Australian Operations and Investor Relations, Australia
- Joined 2019
- BEc (Hons, University of Adelaide)
- MEc (Monash University)
Mr Malcolm Bull joined CLINUVEL in January 2019 and initially built out the Company's investor relations program with a focus on analyst and Australian institutional engagement. Recognising the need for greater operational support in Australia amidst the COVID-19 pandemic, Mr Bull's role with CLINUVEL evolved in 2021 to the remit of Head of Australian Operations and Investor Relations. Previously an economist within the Australian Federal Government and private sector, Mr Bull then spent more than two decades in banking across credit, business development and strategy, and relationship management, working with Commonwealth Bank of Australia, Bank of Western Australia, National Australia Bank, and ANZ. This included time in general management for ANZ in the Philippines and as part of the Victorian state management team for CBA Corporate. Mr Bull has managed to attract six sell-side analysts since his arrival and increased institutional ownership of CLINUVEL from 25% to 35% of issued capital.
“The positive impact of SCENESSE® on the lives of EPP patients spurs my team every day to work to extend its use to new patients.”
Antonella Colucci
- VP, Commercial Affairs, Switzerland
- Joined 2011
- MA (European Studies and Global Affairs, Catholic University of the Sacred Heart)
- MA (Modern Languages, IULM Milan)
- Executive education: Harvard Business School, London Business School
Mrs Antonella Colucci is responsible for commercial matters ex-North America while working closely with the US team to ensure continuity of business. Having spent many years working within the medical industry in Italy, Mrs Colucci was instrumental in the expansion of CLINUVEL's Italian 648/96 program and subsequent Swiss special access scheme. These two programs – which facilitated subsidised reimbursement of the drug prior to its marketing authorisation – provided CLINUVEL with commercial proof-of-concept for SCENESSE® and laid the foundations for Mrs Colucci to lead the Company's successful commercial activities since 2016. With responsibilities across pricing, compliance, and distribution, Mrs Colucci is currently focused on expanding the Company's commercial reach in both new and existing regions.
“We pride ourselves on vigilance to quality and the standards that are essential to ensure the smooth performance of the business.”
Dr Azza Hamila
- Head of Quality Assurance and Drug Safety, UK
- Joined 2015
- BPharm (University Claude Bernard)
- MPharm (University Paris Descartes)
Dr Azza Hamila has played a central role in CLINUVEL's commercial scale-up, establishing new internal standards in GxP, with a focus on manufacturing, distribution, and pharmacovigilance. Her work has enabled the Company to achieve long-standing compliance, giving authorities comfort that CLINUVEL conforms to strict international regulations and can maintain the licences necessary to perform critical manufacturing and distribution functions in-house. Dr Hamila's position encompasses both Responsible Person and Qualified Person roles in various jurisdictions within the quality management system, as well as being responsible for supplier management and patient safety. She has previously held quality assurance roles with Orphan Europe (Recordati), Sanofi Aventis, and Roche before joining CLINUVEL in 2015.
“Managing the strategic expansion and daily operations of this international biopharmaceutical group provides our teams an ongoing professional challenge.”
Lachlan Hay
- Director of Global Operations, Singapore
- Joined 2007
- BA (Media Comms, University of Melbourne)
- MA (International Relations, Freie Universität Berlin)
- Executive education: INSEAD, Harvard Business School, NYU Stern, London Business School
As Director of Global Operations, Mr Lachlan Hay supports the executive and senior management teams as well as maintaining responsibility for the delivery of key business objectives. Having joined the business in a corporate communications role in Australia, Mr Hay then assumed roles in Europe and Asia. He was the first General Manager of the UK business, overseeing the introduction of SCENESSE® into European markets since 2016, and assumed a broader operational position in response to the needs of the business. On 1 July 2024, Mr Hay assumed the position of Chief Operations Officer, providing him more responsibilities. He is also completing his law degree (LLM).
“I am proud to have played a leading role as CFO and Company Secretary, in CLINUVEL's progression from an R&D based enterprise to a profitable commercial operation, expanding for the future.”
Darren Keamy
- CFO & Company Secretary, Australia
- Joined 2005 – to 1 July 2024
- BComm (Accounting, La Trobe University)
- CPA
- GradDip Applied Corporate Governance (Governance Institute of Australia)
Mr Keamy held the dual role of Chief Financial Officer and Company Secretary from 2005 to 1 July 2024. For 19 years, he ensured the Company operated with a high level of financial discipline while maintaining a strong focus on governance and compliance. From early in his time with CLINUVEL, Mr Keamy was responsible for maintaining strict controls to enable the Company to achieve profitability and reinvest in long-term growth. As the business evolved, Mr Keamy oversaw the addition of new entities and structures to both enable commercial sales as well as maintain tax efficiencies. Mr Keamy provided counsel to the Board across his role as well as maintaining corporate governance structures for the Group and leading global compliance. A qualified CPA, Mr Keamy previously held roles with global packaging specialists Amcor in Australia, as well as Salomon Smith Barney (now part of Citigroup) and Superdrug Stores in the UK.
Reflecting the complexities of the business, the Chief Financial Officer and Company Secretary roles have now been separated.
“It is satisfying to meet the challenge to gain marketing authorisations and subsequently, to meet all of the regulatory reporting requirements to maintain them.”
Dr Rose Quadbeck-Diel
- Snr VP Regulatory Affairs, Switzerland
- Joined 2012
- BSc (Nutrition, Justus Liebig-Universität)
- PhD (Biochemistry, Johann-Wolfgang Goethe-University)
Having spent over 30 years in global regulatory affairs and quality assurance in large and mid-sized pharmaceutical entities in Germany and Switzerland – including Baxter Oncology, Asta Medica, and Mundipharma – Dr Rose Quadbeck-Diel ensures CLINUVEL is compliant with, and able to adapt to, a changing regulatory landscape. In her time with CLINUVEL this has included navigating marketing authorisation filings and compliance, shaping the Company's Brexit response, and implementing new European regulatory initiatives such as the falsified medicines regulations. In recent years Dr Quadbeck-Diel has worked to expand CLINUVEL's regulatory team to prepare long-term regulatory projects and new marketing filings.
“I am thrilled to re-join CLINUVEL and advance its expanded clinical programs, particularly in vitiligo.”
Dr Emilie Rodenburger
- Director, Global Clinical Affairs
- Joined April 2024
- PharmD (Paris Descartes University, France)
- MSc (Paris-Sud University, France)
Dr Emilie Rodenburger rejoined CLINUVEL in April 2024 as Director Clinical Affairs. Returning to CLINUVEL after four years with Roche in senior clinical roles, Dr Rodenburger oversees CLINUVEL's global clinical program, evaluating melanocortin based drugs for a range of disorders of the skin and brain. Her immediate focus will be to ensure full enrolment and analyses of the CUV105 study of SCENESSE® in vitiligo (loss of pigmentation). A pharmacist (PharmD) with a master's degree in cancer biology, Dr Rodenburger previously worked with the CLINUVEL Group for over a decade in clinical development roles in Australia, the USA and Europe. During this time, she led the Company's first vitiligo trials as well as being one of two clinical managers completing the EPP program resulting in the successful approval and commercialisation of SCENESSE® as the first systemic photoprotective therapy.
“Since April 2020, we’ve built a strong foundation with EPP in the US. Now, we’re excited to expand our treatment to vitiligo and other unmet needs.”
Dr Linda Teng
- Director of North American Operations, USA
- Joined 2007
- BPharm (National Taiwan University)
- Doctor of Health Administration (Medical University of South Carolina)
- Executive education: Columbia Business School
As Director of North American Operations, Dr Linda Teng has established the Company's commercial presence, building a network of Specialty Centers and commercial programs enabling EPP patients to receive treatment in both the USA and Canada. With a background in clinical pharmacy and clinical pharmaceutical development – at BioMarin and for more than 16 years at CLINUVEL – Dr Teng also heads the vitiligo program in North America. The US team has grown quickly over the past 18 months to incorporate new functions, including patient support and in-house counsel, adding complexity but greater bandwidth to the operations under Dr.Teng's purview.
“I’m excited to join the high performing CLINUVEL team, and lead the disciplined financial stewardship as we build the foundations of new revenue streams for future growth.”
Peter Vaughan
- Chief Financial Officer
- Joined April 2024
- BBus (Acc) (Swinburne University)
- Snr. Exec. MBA (Melbourne University – Business School)
- Member, Institute of Chartered Accountants ANZ
- GAICD, AGIA
- Cert. Climate Change: Financial Risks and Opportunities (Imperial College, London)
Mr Peter Vaughan joined CLINUVEL in April 2024 and assumed the Chief Financial Officer role on 1 July 2024. Mr Vaughan has over 20 years of experience in listed and unlisted companies in Australia, the USA, Europe, and Asia. Most recently with Toys “R” Us ANZ Limited as a strategic financial advisor, he has previously held CFO and Company Secretary roles at Titomic (ASX:TTT), Immuron (ASX:IMC, NASDAQ:IMRN), Amaero (ASX:A3D) and Respiri (ASX:RSH), among others. He has led capital raisings, M&A and licensing deals within life science companies, as well as the dual listing of two Australian companies on the Nasdaq (Immuron Limited and Prima Biomed Limited (now Immutep)). Mr Vaughan is a Chartered Accountant, with a BBus (Accounting) from the Swinburne University of Technology and a Senior Executive MBA from Melbourne Business School. He is also a member of Australian Institute of Company Directors and Governance Institute of Australia.
“Applying melanocortin products to treat indications of the skin and brain with unmet needs is exciting. This mission underlies everything we do in the clinical and scientific area of the business.”
Dr Dennis Wright
- Chief Scientific Officer, Australia
- Joined 2005
- BPharm (University of Sydney)
- MSc (University of Sydney)
- PhD (University of Sydney)
- GradCert Health Economics (Monash University)
Dr Dennis Wright has been at the core of the Company's clinical program and regulatory affairs for nearly two decades in the role of Chief Scientific Officer. A pharmacist with a PhD in xenobiotic metabolism, Dr Wright has a pharmaceutical career spanning more than 40 years with Nicholas Kiwi, Faulding/Mayne, CSL and CLINUVEL.
During this time, he worked across basic and clinical research, regulatory affairs, pharmacovigilance, business development, in-licensing, and marketing. It is from this diverse background that he has led CLINUVEL's late-stage clinical development program for EPP as well as steering successful regulatory filings for SCENESSE® in Europe, the USA, Australia, and Israel. His role has extended in recent years to facilitate new clinical programs for afamelanotide as well as overseeing new product development and scientific affairs.