VP Clinical Development, Clinical Research Head Hepatology

Role Summary

Role: VP Clinical Development, Clinical Research Head Hepatology. Location: USA – Massachusetts (Waltham) or Pennsylvania (Upper Providence). On-site presence is required (minimum two days per week). This senior leadership role oversees hepatology clinical development within GSK's Advanced Portfolio Unit (RIIRU), providing end-to-end leadership across discovery and development and partnering with cross-functional teams to shape disease-area strategy and governance.

Responsibilities

• 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.

Qualifications

• Required: Experience in (bio-)pharmaceutical industry with experience in Hepatology or MASH clinical drug development.
• Required: End-to-end clinical development experience including first-in-human trials & proof of mechanism, Ph2 (proof of concept), and Ph3 (registrational studies).
• Required: Experience leading regulatory interactions and submissions (pre-IND/IND, scientific advice, end-of-phase 2, pre-NDA/BLA and files, advisory committee meetings).
• Required: Experience in designing and executing clinical strategies.
• Required: Experience leading projects that harness digital, technological, and statistical tools to support early-stage programs in Hepatology.
• Required: Experience in clinical safety and pharmacovigilance, with expertise in evaluation of safety signals, and proactive risk management strategies.
• Required: Experience with the local and global pharmaceutical industry, competitive landscape, how end-to-end life, and revenue cycles operate.
• Preferred: Experience in navigating, influencing, and championing change in a large, complex, matrixed organization.
• Preferred: Knowledge of advanced trial designs (adaptive and platform trials).
• Preferred: Energized by delivering ambitious standards through collaboration and motivating others across the organization.
• Preferred: Passionate about developing others into future leaders.
• Preferred: 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.
• Preferred: 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.
• Preferred: Ability to balance short-term needs with long-term objectives to lead, resource and inspire teams and strategy according to portfolio priorities.
• Preferred: Experienced and skilled people manager, influencer and disease visionary.
• Preferred: 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.

Education

• Medical degree and clinical medical specialty board qualification in Gastroenterology, Hepatology or Endocrinology.

Skills

• Strategic, end-to-end clinical development leadership across discovery and development lifecycles.
• Medical governance, training, and compliance with internal and external policies, guidance, laws, and codes.
• Excellence in translational and clinical leadership within hepatology.
• Data stewardship for clinical data and related data science efforts, across hepatology programs.
• Cross-functional leadership and collaboration with biology, asset leadership, commercial, precision medicine, biostatistics, regulatory, and medical affairs.
• Resource planning, staffing, and mentoring of clinical staff within the disease area.
• Evidence planning and oversight of innovative trials to support development, approval, commercialization, and patient access.

Additional Requirements

• On-site office presence (minimum of two days per week) at one of GSK’s US sites (Upper Providence, PA or Waltham, MA).