Clinical Development Strategy and Study & Program Design

• Provide effective and experienced 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.
• Lead the design of 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), with an emphasis on early development.
• 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. You will be accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

Clinical Leadership

• Accountable for leading the clinical matrix team (CMT) for a program. Serve as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study, and represent the CMT at early/medicine development teams.
• Actively lead 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.
• Lead clinical evaluation of business development opportunities.
• Remain abreast of advancements in research, clinical trial methodologies, competitive environment and regulatory space in the relevant disease area to maintain GSK’s competitive edge, and disseminate information about recent advances to the relevant GSK colleagues.
• Identify and highlight transformational opportunities for GSK program, for example where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
• Oversee the gathering and support the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the medicine profile.
• Consistently contribute to solving study and overall clinical development challenges, including leading through others.
• Demonstrate ability to lead and 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 Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Medical degree
• Board registration /certification /eligibility in cardiovascular medicine disease, vascular medicine or related specialty.
• Minimum of 5 years of experience in clinical research and development
• Knowledge of and experience in the execution of translational studies including both generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems
• Robust knowledge of cardiovascular medicine research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
• Experience working with global regulatory agencies and managing global clinical trials in relevant disease area.
• Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.
• Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.

Preferred Qualifications:

• PhD in addition to medical degree
• Experience in contributing to IND/CTA, NDA, BLA, or MAA submissions prefe

What we value in you

We value people who put patients first, act with integrity and work collaboratively. We want colleagues who apply clear clinical judgement, communicate honestly, and focus on delivering high-quality results. You will join a team that supports your development and gives you space to grow professionally while making a tangible difference to patient care.

How to apply

If this role speaks to you, please apply with your CV and a short note describing a clinical development or safety activity you led and the impact it delivered. If you need reasonable adjustments to apply or interview, tell us and we will support you. We welcome candidates from many backgrounds and encourage you to apply.

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

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