Clinical Development Senior Medical Director - Vascular

Das ist der Job

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage.

Darum lohnt es sich

You will work closely with colleagues in clinical operations, translational science, regulatory, safety, and commercial teams.

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. • 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.

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.

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.

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.

Basic Qualification • 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.

You will join a team that supports your development and gives you space to grow professionally while making a tangible difference to patient care., 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 This role is hybrid.

If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. 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.

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.

You will lead clinical development medical activities for vascular programmes across early and later phase studies. We value clear clinical judgement, collaborative leadership and a focus on patient impact.

You will shape clinical plans that accelerate safe, meaningful medicines to people with vascular disease while growing your career and influence at GSK. Join us to unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following: • 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.

You will be accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study. You will be accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

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.

Why You? 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 be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

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.

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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.

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. • 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.