05 nov
|
ITech Consult
|
España
05 nov
ITech Consult
España
Clinical Development Lead
- Cardiovascular Clinical Development Lead
- Cardiovascular: Clinical Strategy /Integral Clinical Trials / Medical Device study Background:
* Are you ready to shape the future of healthcare by leading the clinical development strategy for next generation diagnostic solutions? As a Clinical Development Lead, Cardiovascular and metabolic diseases (CVMD) within our Clinical and Medical Affairs organisation in Diagnostics, you will play a pivotal role in planning and implementing clinical development activities that bring medically-differentiated solutions to patients globally. In this role, you will act as a senior strategic voice and trusted advisor, fostering an environment where science and collaboration thrive.
Key Responsibilities
* Drive Clinical Strategy: Lead the clinical development strategy for large-scale studies and complex programs, in the CVMD area, defining clinical utility, intended use, and claim extensions across our portfolio.
* Lead Health Authority Interactions: Work closely with Global Regulatory Affairs in the completion and submission of global regulatory filings, authoring critical sections of meeting packages and reviewing clinical documents for international regulatory submissions.
* Forge Stakeholder Partnerships: Act as the medical lead in external interactions with health authorities, build strategic relationships with international Key Opinion Leaders (KOLs), and drive development partnerships across industry and academia.
* Foster Communication Excellence: Oversee the implementation of communication strategies for clinical studies, representing the organisation at major medical congresses, advisory boards, and in key publications.
* Champion Innovation & Excellence: Act as a key driver for competitive differentiation,
innovation, and early pipeline activities while developing intellectual property strategies and optimising clinical processes.
* Coach and Mentor: Act as a dedicated coach for team members, nurturing confidence and helping colleagues develop their skills and expertise. Must Haves:
* Medical degree (MD) or an advanced degree (PhD) in cardiology, metabolic diseases, obesity or related fields.
* Established experience within academia, diagnostics, or the pharmaceutical industry, in the CVMD area.
* Clinical Expertise: Proven track record in In Vitro Diagnostics (IVD) or Medical Device study management across all stages of global clinical trials, including protocol design and report writing.
* Program Leadership: Demonstrated experience leading large, complex development programs and guiding cross-functional, matrixed teams.
* Regulatory Knowledge: Deep understanding of applicable global standards and regulations, such as ICH-GCP, IVDD/IVDR, MDR, FDA, and NMPA.
* Inclusion & Collaboration: Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration.
* Travel: Willingness to travel up to 25% depending on project phases.
* Who You Are :You are an analytical, strategic thinker who thrives in a fast-paced, matrixed environment. You are passionate about customer and patient-centricity, and you excel at integrating multiple cross-functional perspectives into a unified clinical strategy. Referenz Nr.: 925235 Rolle: Clinical Development Lead
- Cardiovascular Industrie: Pharma Arbeitsort: Spain/Austria/UK Pensum: 100% Start Datum: ASAP Dauer: 12++ Months with a possibility of extension Bewerbungsfrist: 22/09/2026 attraktives Payroll-Only-Programm: +41 41 760 77 01. #J-18808-Ljbffr
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