Clinical Development Medical Director- Hepatology

For candidates seeking to be located at our Stevenage site this role will temporarily be based at Stevenage. However the Company plans to relocate its offices to Cambridge. The location of this role will therefore subsequently change to Cambridge in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

At GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.

We are seeking an experienced Medical Director for the role of Medical Director Clinical Development- Hepatology within GSKs Respiratory Immunology & Inflammation Research Unit. If appointed to this role you will have key responsibility for the identification of next generation targets for liver disease and the progression of assets directed towards them into the clinic to demonstrate proof of concept. To do this you will provide medical and scientific expertise and leadership to clinical and translational studies at and above asset-level; contribute to assessment of the therapeutic potential of novel mechanisms and targets collaborate in the design of target validation programs identify and drive life-cycle expansion and innovative clinical development opportunities. You will work cross-functionally to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data and translational and biomarker capabilities within a department that prioritizes understanding mechanism and unmet need alongside innovative clinical development helping us deliver differentiated medicines that change the course of disease and improve patients lives.

In the Respiratory Immunology and Inflammation Research Unit (RIIRU) our enduring purpose is to leverage science to identify novel treatments to address underlying organ dysfunction and disease. We are trailblazing a pipeline of medicines to dramatically improve how we cure and care for patients. We are a diverse team of industry-leading experts who channel our passion for scientific exploration into true value for patients and GSK. We drive the end-to-end R&D journey fueling early discovery and our mid-stage pipeline while also advancing our late-stage medicines to launch. We are combining field-leading data sets capabilities and methods with decades of knowledge to transform our success in how we innovate new medicines.

Working model:

This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

Position Summary:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Clinical Development Strategy and Study & Program Design

• Provide effective support and oversight of R&D evidence generation strategy plan and activities to ensure patient safety and on-time in-full study delivery. Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific clinical commercial regulatory stats etc.) to contribute to vital deliverables including early medicine profile target validation translational plans candidate selection.
• Design clinical development plans study protocols and associated documents across all phases of development reflecting internal and external stakeholder input (e.g. patients evidence generation regulators payors pharmacovigilance).
• Bring clinical expertise to regulatory interactions and documents including briefing documents presentations addressing questions and responses for assigned studies and programs.
• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study together with Pharmacovigilance Physician.
• Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
• Define and deliver the clinical pillars of the translational table.
• Deliver clinical development and study timelines and endpoints including pharmacology mechanism and clinical efficacy endpoints enabling key decision points and Go/No Go criteria for the CDP.

Clinical Leadership

• Accountable for leading the Clinical Matrix Team (CMT) for a program. Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study. Represents the CMT at Early/Medicine Development Teams or clinical study at CMT.
• Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages.
• Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders including regulatory agencies key opinion leaders and clinical investigators and with the relevant internal review boards (e.g. Technical Review or Governance) and/or Protocol Review Board.
• Assist with clinical evaluation of business development opportunities
• Stay abreast of advancements in research clinical trial methodologies competitive environment and regulatory space in the relevant disease area to maintain GSKs competitive edge.
• Identify and highlights transformational opportunities; where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
• Gather and supports the integration of inputs from across disciplines (scientific clinical commercial regulatory) to contribute to clinical components of the Medicine Profile (MP).
• Consistently contribute to solving study and overall clinical development challenges.
• Demonstrate ability to influence others at project departmental and inter-departmental levels as appropriate

Creating Innovative Scientific and Technical Solutions

• Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions.
• Promote an environment for others to generate ideas for improvement and proactively drives innovation beyond taking advantage of opportunities that arise.

Influencing and Inspiring Others and Managing Conflict

• Consistently achieves desired outcomes through strong influencing skills including understanding others perspectives building trust tailoring communications depending on the audience and using persuasive arguments to gain support.
• Able to consistently inspire others by setting a positive example communicating a compelling vision and creating an environment where team members feel valued and motivated.
• Manage conflicts effectively and independently negotiating mutually acceptable solutions.

Enterprise Mindset Strategic Thinking and Navigating Ambiguity

• Demonstrate enterprise mindset with effective collaboration across the matrix able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.
• Analyses interprets and critically evaluates data information and digital content to interpret complex information anticipate obstacles and identify potential solutions.
• Demonstrate flexibility and adaptability in changing environments able to analyze incomplete information identify potential risks and implications and make informed decisions.

Why You

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals

• Medical Degree
• Completion of a formal postgraduate clinical training clinical residency or specialty training in Internal Medicine Pathology etc.
• Demonstrated experience in clinical trial conduct including medical monitoring safety review and clinical data interpretation
• Strong working knowledge of clinical development processes including GCP ICH guidelines and global regulatory frameworks
• Ability to apply clinical judgement to support study design patient safety and real-time medical decision-making within a structured clinical development framework
• Experience operating effectively within cross-functional matrix teams in a pharmaceutical biotechnology or academic clinical trial environment
• Strong scientific communication skills with the ability to translate clinical data into clear insights for internal and external audiences

Preferred Qualifications:

In addition to the above you will stand out if you bring the following

• Completion of advanced specialty training fellowship or country-equivalent higher-level qualification in Hepatology (or Gastroenterology) leading to recognition as a medical specialist through formal certification board certification or country specific professional designation
• Experience in pharmaceutical or biotechnology clinical development across early phase studies.
• Clinical experience in hepatology and/or relevant therapeutic areas with direct exposure to clinical research or drug development in industry or postgraduate work
• Robust knowledge of liver disease research priorities public health needs competitor landscape clinical practice trends and treatment guidelines evolution
• Knowledge of and experience in the execution of clinical and/or translational studies including generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems.
• Experience working with global regulatory agencies and managing global clinical trials in relevant disease area
• Prior experience contributing to regulatory interactions (e.g. IND submissions scientific advice NDA/MAA filings)
• Demonstrated experience engaging with Key External Experts (KEEs) investigators and scientific collaborators in Liver Disease
• Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.
• Experience in contributing to IND/CTA NDA BLA or MAA submissions

Skills

Clinical Development Communication Drug Regulatory Affairs Evidence Based Decision Making Good Clinical Practice (GCP) Influencing Without Authority Learning Agility People Management Project Management Scientific Presentations Strategic Thinking

If you are based in Cambridge MA; Waltham MA; Rockville MD; or San Francisco CA the annual base salary for new hires in this position ranges $222750 to $371250. If you are based in another US location the annual base salary range is $202500 to $337500. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the addition this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. 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 in the job posting for a specific country the relevant compensation will be discussed during the recruitment process.

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 were 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.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.

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Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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Director

Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 202500 - 337500