Clinical Development Medical Director- Vascular

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.

The Clinical Development Medical Director provides clinical and scientific insights and leadership to clinical and translational studies or programs that modulate vascular biology and pathology within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will be a subject matter expert in disease driven by vascular pathology.

You will work within project teams to plan, execute, and deliver activities including translational and clinical development strategies and clinical studies across a range of therapy areas with a focus on disease driven by systemic inflammation and endothelial dysfunction. You will work cross-functionally to develop and execute clinical development plans up to and including proof-of-mechanism/proof-of-concept studies.

Key Accountabilities / Responsibilities:

• Be an expert in translational medicine and early clinical development in vascular & related disease.
• Provide scientific and clinical leadership to strengthen RIIRU’s capabilities in translation and early clinical development programs that modulate inflammation and endothelial dysfunction using a range of drug modalities, including oligonucleotides, biologics and small molecules.
• Act as a subject matter expert in clinical development drugs that modulate inflammation and endothelial dysfunction.
• Support the design of translational and clinical plans that support project strategy.
• Support the execution of high-quality evidence-gathering and clinical development plans that offer swift paths to new safe and effective medicines.
• Lead development of clinical sections of core regulatory documents.
• Contribute to the design and execution of clinical studies that generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
• Seek, build and maintain relationships with program counterparts in biology, translational, commercial, research technologies, regulatory affairs, clinical operations, market access, medical affairs and statistics.
• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in clinical development.
• Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
• Contribute to study team discussions on indication planning, incorporating input from across disciplines (e.g. biology, clinical, commercial, regulatory, statistics) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.
• Design clinical development plans and study protocols across all phases of development – with a focus on phases 1 and 2 – reflecting internal and external stakeholder input (e.g. patients, evidence generation, regulators, payors, pharmacovigilance).
• Develop other asset- and study-related documents, including protocol amendments, investigator brochures, clinical study reports.
• Provide clinical input to regulatory interactions and documents and responses to regulatory feedback 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.
• Be accountable for leading the clinical matrix team (CMT) on EPU programs.
• Serve as a clinical point of contact both internally and externally (e.g. regulatory agencies, academic collaborators, investigators, external experts) for one or more asset or indication, or for a clinical study.
• Actively collaborate to design and deliver the end-to-end clinical development strategy for one or more EPU programs and may contribute to later clinical development stages.
• Serve as the primary clinical interface with the relevant internal RIIRU/GSK governance review boards and protocol review board.
• Contribute to clinical evaluation of business development opportunities.
• Gather and support the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the medicine profile.
• Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate.
• Consistently inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
• Demonstrate experience in managing conflicts effectively and independently, negotiating mutually acceptable solutions.
• Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete or imprecise information, identify potential risks and implications, and make informed decisions.
• Embrace challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas.
• Proactively generate ideas for innovative improvement and takes advantage of opportunities that arise; promotes environment for others to generate ideas for improvement.

Basic Qualifications:

• Medical degree from accredited medical school.
• Completion of a clinical residency program.
• Experience in clinical research and development.

Preferred Qualifications:

• Board certification in internal medicine, cardiology, clinical pharmacology or a related specialty.
• Deep understanding of vascular medicine or vascular biology.
• Experience in translational and clinical research in vascular medicine allied to one or more internal medicine specialty (e.g. cardiology, metabolic medicine, nephrology, hepatology, neurology) either in a clinical academic setting or in a biotech or pharma organization.
• Involvement in cross-functional matrix teams designing and executing clinical trials to relevant regulatory standards.
• Experience in contributing to NDA, BLA or MAA submissions.
• Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.

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.

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.