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 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. Find out more: Our approach to R&D Position Summary 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: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following Be an expert in translational medicine and early clinical development in vascular & related disease: Provide scientific and clinical leadership to strengthen RIIRU 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. This includes designing and delivering the clinical elements of a translational strategy and designing and delivering 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 clinical development plan. 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 Contribute to clinical development strategy, program and study design: 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, incorporates 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. If you are a physician, this includes accountability for medical governance across the project to ensure scientific integrity and overall safety of the study participants. Be a clinical leader: 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. Represent the clinical matrix team at the early development team (EDT) or clinical study at CMT. 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. Consistently contribute to the solving of study and overall clinical development plan problems. Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate. Influence and inspire others, and manage conflict: 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. Consistently achieve 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. Have an enterprise mindset and navigate ambiguity: Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete or imprecise information, identify potential risks and implications, and make informed decisions. 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. 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 Why You? Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Medical degree from accredited medical school Completion of a clinical residency program Experience in clinical research and development Preferred Qualifications: If you have the following characteristics, it would be a plus: 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 • 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 $222,750 to $371,250. • If you are based in another US location, the annual base salary range is $202,500 to $337,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate 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, 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 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call. 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For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.