Associate Director, Clinical Scientist – Oncology
GSK
VP Clinical Development, Clinical Research Head – Hepatology
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- 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.
Requirements
- 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.
Benefits
- Health insurance
- 401(k)
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentfirst-in-human trialsproof of mechanismPhase 2 studiesPhase 3 studiesregulatory submissionsclinical strategiesclinical safetypharmacovigilancerisk management
Soft skills
leadershipmentoringaccountabilitystrategic thinkingcommunicationcollaborationproblem-solvingknowledge sharingtrainingcompliance
Certifications
medical degreeclinical medical specialty board qualification
