Vice President Clinical Affairs
hace 2 días
Uxbridge
Job Title: Vice President, Clinical Affairs Location: London, UK (Hybrid – 2 days per week onsite) Job Type: Permanent About the Role We are seeking a seasoned and strategically minded Vice President of Clinical Affairs to lead the global clinical development function for an innovative Class III cardiovascular medical device portfolio. This is a critical executive role, operating at both board and operational levels, responsible for shaping clinical strategy, advising senior leadership, and ensuring the successful design and execution of complex clinical programs—from first-in-human through pivotal trials. This position requires a highly experienced clinical leader who can confidently navigate the nuances of early feasibility studies, first-in-human trials, and pivotal study design, particularly within cardiovascular and implantable device environments. Key Responsibilities • Define and lead global clinical strategy aligned with regulatory and commercial objectives, • Act as a trusted advisor to the Board and Executive Leadership Team on clinical development pathways, risk, and opportunity, • Design innovative and efficient clinical development plans, including feasibility, first-in-human, and pivotal trials, • Assess and advise on optimal geographies for early-stage trials (e.g., Netherlands, Australia), including regulatory, ethical, and operational considerations, • Evaluate opportunities to streamline development timelines, including combining or sequencing early-phase studies where appropriate, • Provide expert guidance on study design, endpoints, patient selection, and statistical methodologies for Class III cardiovascular devices, • Oversee clinical trial execution, ensuring quality, compliance, and timely delivery, • Collaborate closely with Regulatory Affairs to align clinical evidence generation with MDR, FDA, and global requirements, • Engage with investigators, key opinion leaders (KOLs), and clinical partners to build strong study networks, • Lead interactions with regulatory bodies and ethics committees as needed, • Build and lead a high-performing clinical affairs team and external partnerships (CROs, consultants), • Extensive experience in Clinical Affairs within the medical device industry, with a focus on Class III cardiovascular or implantable devices, • Proven track record designing and executing first-in-human, early feasibility, and pivotal clinical trials, • Deep understanding of global clinical and regulatory frameworks, including EU MDR and US FDA requirements, • Demonstrated experience advising executive leadership and Boards on clinical strategy and development pathways, • Strong expertise in trial design, including adaptive designs and efficient study sequencing, • Experience working with international trial sites, particularly in Europe and Australia, • Ability to critically assess and optimise clinical development order, timelines, and evidence generation strategies, • Experience in start-up or scale-up environments, • Familiarity with combining early-phase studies or innovative trial methodologies, • Strong network of cardiovascular investigators and clinical experts, • Competitive executive compensation and benefits package, • Opportunity to lead clinical strategy for groundbreaking cardiovascular technologies, • Direct influence at Board level and across global development strategy, • Collaborative, innovation-driven environment, • Hybrid working model with London office presence (2 days per week) If you are a visionary clinical leader with deep expertise in cardiovascular medical devices and a passion for bringing transformative therapies to patients efficiently and safely, we would love to hear from you.