Stephen Wright

About Stephen Wright

Guiding the transfer of scientific innovation from the laboratory to the patient is my passion, and I have led internationally dispersed, cross-functional teams in the delivery of new treatment therapies to patients across the globe.I have a wealth of experience leading across the entire product lifecycle from manufacturing, development, and commercialization of products and have paved the path for multiple global approvals for Actemra across immunology and also as a viable treatment of patients with severe COVID-19. I’ve worked with scientific experts and senior leadership in steering teams toward the achievement of short- and long-range goals, stepping up to accelerate the study of therapies to address and meet the needs of an emerging pandemic.Since my early career days as a Clinical Scientist (Medical Director), I’ve worked hard to lead teams in global product development and acted as clinical lead for FDA, EMA30%. Tactics included creating and executing the strategy needed to meet the demand triggered by a global pandemic.PEOPLE LEADERSHIP: An expert at building and synergizing high-performance teams, I set the course for excellence and then lead, coach, and mentor team members –ensuring everyone has the information, support, and tools necessary to succeed.PROJECT MANAGEMENT: Throughout my career, I have powered international teams, directing high value projects and programs. In addition, I have a reputation for delivering global development programs for both pediatric and adult diseases, including device development with multiple interactions with global regulatory agencies and filing submissions for original BLA, supplemental BLA and Type II variations and gaining biologic license and market authorization applications.

Experience

1. Lifecycle Leader Global Product Strategy Role

   Roche

   Jan 2020 — Present · San Francisco, CA, US

   Stepped into a new role at Roche/GNE in response to COVID-19 and evolving data, revealing globally approved biologic therapy (Actemra) could help patients with severe COVID-19 pneumonia. Took the lead of an Executive level team to help steer a cross-functional team of ~500 people globally to progress novel studies through approval and market delivery in record time. Recipient of 2 Roche Rethink Development Awards. Scientific + Strategic Leadership: Outpaced competitors, breaking all previous records for study startup, conduct, and analysis of 3 global phase 3 studies of Actemra and earned emergency use authorization (EUA) for COVID-19 and EMA approval- Steered delivery of first submission to WHO (2021) for a Roche medicine product qualification and earned placement in WHO guidelines for viable treatment of COVID-19- Partnered with WHO, devising a plan for Actemra availability in developing countries. Build Relationships with Key Scientific Experts: Engaged with and supported >15 globally initiated studies, including the largest clinical study of severe COVID-19 led by the UK (The RECOVERY study). Champion Solutions to Complex Challenges: Provided leadership necessary to nearly triple Actemra product supply, positioning company, and capability to treat >1M patients experiencing severe COVID-19 with 60% of those affected from developing countries- Ensured continuity of product + equitable distribution, managing central allocation of supply and meeting unprecedented demand- Minimized country-level stock-outs, collaborating with multiple NGOs and Governmental organizations on sustainable strategies to enhance supply and meet demand.

Education

• Royal College of Physicians London

  MRCP(UK), Medicine

  2002

• Queen's University Belfast

  Bachelor of Medicine, MB(Hons) BCh BAO, Medicine

  1993 — 1998

• Queen's University Belfast

  Doctor of Medicine MD, Medicine

  2004 — 2006

Skills

• Pharmaceutical Industry
• Life Sciences
• Medicine
• CRO
• Medical Affairs
• Biotechnology
• Clinical Research
• Clinical Development
• Translational Medicine
• Clinical Trials
• Infectious Diseases
• Drug Development
• Gcp
• Therapeutic Areas
• Ctms
• Oncology
• Rheumatology
• Clinical Trial Management