VP Clinical Development, Clinical Research Head Hepatology

VP Clinical Development, Clinical Research Head Hepatology

Are you an exceptional clinical development leader in Hepatology, driven to advance cutting-edge science and deliver impactful medicines to patients? If so, this VP Clinical Development, Clinical Research Head Hepatology position offers a unique opportunity to lead and innovate within GSK's advanced portfolio.

GSK seeks an outstanding leader in clinical development to join as VP Clinical Development, Clinical Research Head Hepatology within the Advanced Portfolio. The Advanced Portfolio Unit works within the Respiratory, Immunology and Inflammation Research Unit (RIIRU).

This represents a critical and senior role at GSK, with an opportunity to provide leadership across the full discovery and development lifecycle of our hepatology portfolio. This will require close partnering with leaders from within RIIRU as well as key cross functional partners across the organization.

The role will report into the SVP & Head of the Advanced Portfolio Unit, and you will have direct line function responsibility for all Clinical Leads aligned to Hepatology medicines. As an individual with end-to-end clinical expertise, you will also be required to operate across the broader matrix at a leadership level, partnering with line heads in biology, asset / medicine leadership, commercial, precision medicine, biostatistics, regulatory and medical affairs, as well as contribute to project and above-project governance.

Your role will include the accountability of evolving disease area strategies within hepatology and potential adjacencies, ensuring the quality and robustness of the medicine vision, integrated evidence plan and innovative trials for programs to support the development, approval, commercialization, and patient access to differentiated medicines with proven value. You will also be accountable for Medical Governance for clinical programs.

This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK's US (Upper Providence, PA or Waltham, MA) sites.

Key responsibilities include :

• Lead building a portfolio of programs within the Hepatology TA that have clear potential for product differentiation, tractability in development and with associated technical success probabilities that can support clear investment decisions.
• Be accountable for the delivery of the full spectrum of advanced clinical development studies and submissions, Ph1b / 2a through filing in hepatology.
• Be the single point of accountability for disease area strategy developed with input from internal GSK leaders & external academic thought leaders, research leads, regulatory authorities, investigators, and patient groups.
• Lead milestone transitions from candidate selection to filing / launch, guiding Clinical Leads on optimized strategies and alternative pathways to enable informed, strategic risk-taking.
• Provide Medical Governance with specific accountability for managing and mentoring clinical staff in the disease area line and ensure proper training and compliance with internal and external policies, guidance, laws, and codes.
• Develop and maintain excellence in translational and clinical leadership in the disease area.
• Ensure the quality of clinical deliverables within the disease area including all documents and submissions including clinical data, through methods such as peer review, knowledge sharing / management, and standards and compliance.
• Function as Data Steward of the clinical data for the disease area (may include multiple assets), with oversight of breadth of disease data strategies and related data science efforts relevant to Hepatology TAs, to ensure activities are applied to benefit and impact of programs.
• Manage resourcing of clinical projects within the disease area across the assets in scope including portfolio projects and programs (encompassing early projects prior to candidate selection, through early and late-stage clinical development) and business development / due diligence activities).

Basic Qualifications : Medical degree and clinical medical specialty board qualification in Gastroenterology, Hepatology or Endocrinology. Experience in (bio-)pharmaceutical industry with experience in Hepatology or MASH clinical drug development. End-to-end clinical development experience including first-in-human trials & proof of mechanism, Ph2 (proof of concept), and Ph3 (registrational studies). Experience leading regulatory interactions and submissions (pre-IND / IND, scientific advice, end-of-phase 2, pre-NDA / BLA and files, advisory committee meetings). Experience in designing and executing clinical strategies. Experience leading projects that harness digital, technological, and statistical tools to support early-stage programs in Hepatology. Experience in clinical safety and pharmacovigilance, with expertise in evaluation of safety signals, and proactive risk management strategies. Experience with the local and global pharmaceutical industry, competitive landscape, how end-to-end life, and revenue cycles operate.

Preferred Qualifications : Experience in navigating, influencing, and championing change in a large, complex, matrixed organization. Knowledge of advanced trial designs (adaptive and platform trials). Energized by delivering ambitious standards through collaboration and motivating others across the organization. Passionate about developing others into future leaders. Ability to think outside of conventional classifications of disease, where appropriate, and utilize cutting-edge translational data (genetic, cellular, or systems biology) to support innovative translational strategies. Experience in leveraging expert knowledge for scientific, technical, clinical, and regulatory forward looking strategic thinking, problem solving and decision making in the evolving healthcare and digital data environments. Ability to balance short-term needs with long-term objectives to lead, resource and inspire teams and strategy according to portfolio priorities. Experienced and skilled people manager, influencer and disease visionary. Experienced in stakeholder management skills, across scientific, academic, regulatory, and political communities to identify and achieve mutual goals for the well-being of patients and our communities.

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.