The pharmaceutical and biotechnology sectors have undergone a significant reshuffling of leadership positions during the first two months of 2025, with several high-profile executives changing roles across major companies and regulatory bodies.
FDA Regulator Moves to Pfizer, Sparking Controversy
In a move that has generated considerable discussion within the industry, Patricia Cavazzoni has joined Pfizer as Chief Medical Officer after resigning from her position as head of the FDA's Center for Drug Evaluation and Research (CDER). The transition has prompted criticism regarding the "revolving door" between regulatory agencies and the pharmaceutical industry.
At Pfizer, Cavazzoni will oversee regulatory affairs, pharmacovigilance, safety, epidemiology, and medical information functions, reporting directly to R&D chief Chris Boshoff. She succeeds Aida Habtezion, who is departing the company.
Major Leadership Changes at Global Pharma Companies
Boehringer Ingelheim has appointed Brian Hilberdink as president of US human pharma. Hilberdink brings substantial experience from his 26-year tenure at Novo Nordisk, where he successfully launched multiple blockbuster products and rare disease biologics, following a brief stint as Executive Vice President at LEO Pharma.
In the UK, two major pharmaceutical companies have strengthened their leadership teams. Dr. Stevan Shaw, a researcher at UCB since 1993, has been named head of UK research at the company, succeeding Dr. Alistair Henry who became Chief Scientific Officer in October. Meanwhile, Novo Nordisk appointed Sebnem Avsar Tuna, a two-decade veteran of the company, as UK general manager after she most recently led the company's Asia-Pacific operations.
Takeda is preparing for a significant transition as CEO Christophe Weber announced his planned departure in June 2026 after 11 years at the helm of Japan's largest pharmaceutical company. Julie Kim, who joined Takeda in 2019, has been named as Weber's successor in what appears to be a carefully orchestrated leadership transition.
New Leadership in Specialty Pharma
Indivior, a US-based global specialty pharmaceutical company focused on treatments for opioid use disorder, has appointed Joe Ciaffoni as CEO. Ciaffoni brings over 30 years of industry experience, having most recently served as president and CEO of Collegium Pharmaceutical. His background includes senior positions at Endo International, Biogen, and Shionogi.
Biotech Firms Strengthen Clinical Development Teams
Several biotechnology companies have made strategic appointments to enhance their clinical development capabilities:
FreeOx Biotech, developing treatments for acute ischemic stroke, has expanded its leadership team with three key appointments. Pat Nasshorn joined as Chief Business Development Officer, bringing experience from Merck, Johnson & Johnson, and Bristol-Myers Squibb. Dr. Ian Hitchcock was named Chief Development Officer, with a 25-year career including roles at Abbott, Bristol-Myers Squibb, and Celgene. Dr. Jina Swartz, with experience in academic neurology and global clinical development at companies including Merck and GSK, was appointed Chief Medical Officer.
Ona Therapeutics, a Barcelona-based biotech working on novel antibody-drug conjugates, named Stéphane Durant des Aulnois as Chief Financial Officer after nine years in finance roles at Ipsen. Additionally, Dr. Jutta Amersdorffer joined as Chief Medical Officer, bringing experience from Sandoz, MorphoSys, and Otsuka Novel Products.
Business Development and Regulatory Expertise
LB Pharma, a New York clinical-stage biopharma developing therapies for neuropsychiatric diseases including schizophrenia, appointed Gad Soffer as Chief Business Officer. In a previous role at Rheos, Soffer secured a $700 million strategic collaboration with Roche.
Dr. Matthew Norkunas joined Tubulis, a Munich and Cambridge, MA-based innovator in antibody-drug conjugates, as Chief Financial Officer and President, bringing extensive financial leadership experience from Generation Bio and SomaLogic.
Aspargo Labs, a New York specialty pharma and med tech company converting existing medications to liquid oral suspensions, named Mario Guralnik as Chief Regulatory Officer, bringing regulatory affairs experience from Amgen and extensive involvement with FDA advisory boards.
Scientific Leadership Transitions
January saw several significant appointments of Chief Scientific Officers across the industry:
Dr. Jacques Dumas joined AiCuris from Arrakis Therapeutics, where he had led R&D activities and managed collaborations with Roche and Amgen. AiCuris focuses on developing therapies for immunocompromised patients requiring effective infection treatments.
Dr. Margit Janat-Amsbury moved to the CSO position at Halia Therapeutics after serving as CMO at the same company, which is developing therapeutics for chronic inflammatory disorders and neurodegenerative diseases.
Matthew Fyfe became CSO at Outrun Therapeutics following his role as senior vice president of therapeutics at Storm Therapeutics, bringing experience delivering clinical candidates that have reached Phase 2 and beyond in several disease areas.
Prof. Dr. Uli Brödl joined Grünenthal from Boehringer Ingelheim, where he served as corporate senior vice president and head of global clinical development and operations.
RNA specialist Dr. Katie Warner became CSO at Ribometrix, the company she co-founded. Warner was an early pioneer of RNA SHAPE technologies and demonstrated the first structure-based proof-of-principle that RNA is targetable by fragments.
Expanding Commercial Leadership
Multiple companies bolstered their business and commercial teams with strategic hires:
Charlotte Newman, former chief business officer of Agios Pharmaceuticals, joined Cardurion Pharmaceuticals as CBO, bringing experience from strategic product and portfolio roles at Biogen.
Hannah Seitz became CBO at LabGenius, a drug discovery company pioneering machine learning for therapeutic antibody discovery, after serving as VP global business development at Evotec.
Jamie Coleman took the chief commercial officer position at Kailera Therapeutics after holding key roles at Eli Lilly, most recently serving as vice president, US brand leader for Zepbound.
Dan Monahan joined Amylyx Pharmaceuticals as CCO from Otsuka Pharmaceuticals, where he led the US commercialization efforts for the company's CNS franchise, including REXULTI and ABILIFY MAINTENA.
Implications for Industry Direction
These leadership changes reflect the dynamic nature of the pharmaceutical and biotechnology sectors, with companies strategically positioning themselves by acquiring executives with specialized expertise in areas of growing importance, including RNA therapeutics, antibody-drug conjugates, and treatments for neurological and psychiatric conditions.
The movement of talent between regulatory agencies and industry continues to raise questions about potential conflicts of interest, while also highlighting the value of regulatory expertise in navigating increasingly complex approval pathways.
As these new leaders settle into their roles, their influence will likely shape research priorities, business development strategies, and regulatory approaches across the industry throughout 2025 and beyond.
