Clinical Development Senior Medical Director - Vascular

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 285,000 - 474,000; Full time

Job summary

GlaxoSmithKline seeks an experienced Clinical Development Senior Medical Director to lead the Cardiovascular Medicine group within RIIRU. The role focuses on translation and early clinical development of heart failure and atherosclerotic disease programs, with cross-functional leadership across biology, translational sciences, regulatory, and medical affairs.

You will guide CDPs, study design, and evidence generation, ensuring safety and scientific integrity while driving innovative clinical

Qualifications

• Medical degree and board registration or eligibility in cardiovascular medicine.
• Minimum of 5 years of experience in clinical research and development.
• Knowledge of translational studies and generation/analysis of human translational data.
• Robust knowledge of cardiovascular medicine research priorities and regulatory landscape.
• Experience with global regulatory agencies and managing global clinical trials.
• Knowledge of GCP and ethical guidelines for clinical research.
• Ability to work in a cross-functional matrix environment.

Responsibilities

• Lead translational and clinical plan formulation and study designs.
• Generate data to determine target efficacy, safety, and differentiation.
• Define clinical pillars and timelines including endpoints and go/no-go criteria.
• Maintain relationships with biology, translational sciences, regulatory, and commercial teams.
• Lead end-to-end clinical development strategy for early programs.
• Provide medical monitoring and governance for participant safety.

Skills

Cross-functional collaboration

Clinical trial design

Regulatory strategy

Medical writing

Leadership in Clinical Development

Education

Medical degree

Board certification / eligibility in cardiovascular medicine

PhD (preferred)

Job description

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, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

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.

Business Introduction

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 people's 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. We're uniting science, technology, and talent to get ahead of disease together.

In the Respiratory, Immunology, and Inflammation Research Unit (RIIRU), our enduring purpose is to leverage immune science 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, fuelling 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.

We are seeking experienced a Clinical Development Senior Medical Director to join the Cardiovascular Medicine group in GSK's Respiratory, Immunology & Inflammation Research Unit. The group focusses on translation and early clinical development of programmes in heart failure and atherosclerotic disease, particularly in people with comorbid chronic inflammatory disease. In addition to providing clinical and scientific leadership to clinical and translational studies or programmes for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, 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.

What you'll do

• Lead the formulation of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP. Develop sections of core regulatory documents.
• Generate the data and evidence required to determine a target's potential efficacy, safety profile, key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
• 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.
• Establish and maintain relationships with program counterparts in biology, translational sciences, commercial, regulatory, clinical operations, market access, medical affairs and statistics.
• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

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.

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 $284,625 to $474,375. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In 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
• 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 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.

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.