Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage
Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology

Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage

Stevenage Full-Time 72000 - 108000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead clinical development for innovative liver disease treatments and inspire teams to excel.
  • Company: Join GSK, a global biopharma leader dedicated to advancing health.
  • Benefits: Competitive salary, bonuses, comprehensive health benefits, and generous leave policies.
  • Why this job: Make a real impact on patients' lives through groundbreaking research in hepatology.
  • Qualifications: Medical degree with experience in clinical research and drug development.
  • Other info: Dynamic work environment with opportunities for professional growth and collaboration.

The predicted salary is between 72000 - 108000 £ per year.

GSK is seeking a highly skilled Medical Director, Clinical Development, for an Advanced Pipeline Unit (APU) Hepatology group to provide clinical and scientific leadership for potential new, established and emerging indications for assets in clinical development with a strong focus on steatotic liver disease (SLD), including alcohol-associated liver disease (ALD). You will work with project teams to plan and ensure delivery of clinical research and development activities and establish efficient collaboration throughout all stages of development. You will report to the Senior Director/Clinical Development Lead for an asset in the SLD therapeutic area. This role is pivotal in driving GSK's mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. The successful candidate will not only deliver results but also inspire and empower teams to achieve exceptional outcomes.

About RIIRU: The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies).

Please note: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK's US (PA or MA) or UK (Stevenage or London HQ) sites.

Key Responsibilities:

  • Contribute to the clinical development strategy for a drug or program.
  • Ensure execution of clinical development plans (CDP) for product(s) and/or indication(s) and provide strategic oversight and management of clinical trials.
  • Lead clinical development activities from a therapeutic area and clinical trial perspective, including:
  • Provide clinical and medical oversight of ongoing clinical trials
  • Lead clinical trials and asset-level activities in a matrix team structure
  • Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
  • Contribute to development of the Integrated Evidence Strategy (IES). Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and trials.
  • Contribute to clinical development discussions and teams at global regulatory interactions. Draft clinical components of global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
  • Promote innovative methodologies and processes including digital tools, encouraging others to think differently and adopt new ways of working.
  • Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK's competitive edge.
  • Qualifications

    Basic Qualifications:

    • Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Medical.
    • Experience in the global pharmaceutical/biotechnology industry.
    • Experience in clinical research and drug development.
    • Experience in medical monitoring activities and oversight.
    • Experience in leading regulatory submissions and managing global clinical trials.
    • Experience with ICH and GCP guidelines and regulatory requirements.
    • Matrix team experience within a clinical development setting.

    Preferred Qualifications:

    • Medical degree and clinical medical specialty training board qualification/registration in Hepatology/Gastroenterology, Endocrinology or Nephrology.
    • Thorough understanding of SLD, including ALD and MASH, the underlying biology and potential therapeutic targets.
    • Experience in late-stage Hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
    • Solid understanding of needs and priorities of regulators, payers and prescribers in relevant global market(s).
    • Track record of building and maintaining strong relationships with internal and external stakeholders.
    • Demonstrated strong problem-solving skills and innovative thinking. Anticipate potential challenges, develop strategic approaches, and effectively communicate uncertainty to stakeholders while guiding teams through unclear circumstances.
    • Have an enterprise mindset by identifying opportunities for synergy across the organization.
    • Ability to use strategic thinking to analyze, interpret, and critically evaluate complex data and information. Anticipate obstacles and identify innovative solutions to ensure timely delivery of evidence that supports regulatory approvals and patient benefit.
    • Navigate ambiguity by anticipating regulatory challenges and proactively addressing issues.
    • Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules.

    Salary placement and benefits are country/location dependent as described in the posting. For example, in the US, salary ranges are:

    • Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: $222,750 to $371,250
    • Other US locations: $202,500 to $337,500

    The US salary ranges take into account location, candidate skills, experience, education level and market rate. The position offers an annual bonus and eligibility to participate in a long-term incentive program. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed for a specific country, compensation will be discussed during recruitment.

    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 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.

    Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

    GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

    Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage employer: WISE Campaign

    GSK is an exceptional employer that fosters a culture of innovation and collaboration, particularly within its Advanced Pipeline Unit focused on Hepatology. Employees benefit from comprehensive health and retirement plans, generous paid leave, and opportunities for professional growth in a dynamic environment dedicated to advancing transformative medicines. With a commitment to making a positive impact on global health, GSK empowers its team members to thrive while contributing to meaningful advancements in patient care.
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    Contact Detail:

    WISE Campaign Recruiting Team

    StudySmarter Expert Advice 🤫

    We think this is how you could land Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage

    ✨Tip Number 1

    Network like a pro! Reach out to your connections in the industry, especially those who work at GSK or in similar roles. A friendly chat can open doors and give you insider info that could help you stand out.

    ✨Tip Number 2

    Prepare for interviews by diving deep into GSK's recent projects and advancements in hepatology. Show us you’re not just familiar with the basics but are genuinely excited about what we do and how you can contribute.

    ✨Tip Number 3

    Practice your pitch! Be ready to articulate your experience and how it aligns with the role of Medical Director. We want to hear how your background in clinical development can drive our mission forward.

    ✨Tip Number 4

    Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, it shows us you’re serious about joining the GSK team.

    We think you need these skills to ace Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage

    Clinical Development Strategy
    Medical Oversight
    Regulatory Submissions
    Clinical Trial Management
    Experience with ICH and GCP Guidelines
    Matrix Team Leadership
    Understanding of Steatotic Liver Disease (SLD)
    Late-Stage Drug Development
    Strong Problem-Solving Skills
    Strategic Thinking
    Clinical Research Methodology
    Biostatistics Principles
    Stakeholder Relationship Management
    Innovative Thinking
    Data Analysis

    Some tips for your application 🫡

    Tailor Your Application: Make sure to customise your CV and cover letter for the Medical Director role. Highlight your experience in clinical development, especially in Hepatology, and showcase how your skills align with GSK's mission to deliver transformative medicines.

    Showcase Your Leadership Skills: In your application, emphasise your ability to inspire and empower teams. Share examples of how you've led clinical trials or managed cross-functional teams, as this is key for the role at GSK.

    Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to describe your experiences and achievements, making it easy for the hiring team to see your fit for the position.

    Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application is received properly and gives you access to all the latest updates about the role and GSK.

    How to prepare for a job interview at WISE Campaign

    ✨Know Your Stuff

    Make sure you brush up on the latest research and developments in hepatology, especially around steatotic liver disease. Being able to discuss recent advancements or clinical trials will show that you're not just knowledgeable but also passionate about the field.

    ✨Showcase Your Leadership Skills

    As a Medical Director, you'll need to inspire and empower teams. Prepare examples of how you've successfully led projects or teams in the past, particularly in a matrix structure. Highlight your ability to navigate challenges and drive results.

    ✨Understand Regulatory Requirements

    Familiarise yourself with ICH and GCP guidelines, as well as the regulatory landscape for drug development. Be ready to discuss how you've managed regulatory submissions and what strategies you've used to ensure compliance in previous roles.

    ✨Ask Insightful Questions

    Prepare thoughtful questions that demonstrate your understanding of GSK's mission and the role's responsibilities. Inquire about their approach to integrating scientific rationale with commercial goals, or how they envision the future of hepatology treatments. This shows your genuine interest in the position and the company.

    Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage
    WISE Campaign
    Location: Stevenage
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    • Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology in Stevenage

      Stevenage
      Full-Time
      72000 - 108000 £ / year (est.)
    • W

      WISE Campaign

      50-100
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