About Us
Idoven is dedicated to transforming the landscape of cardiology through innovative AI-powered solutions. Our technology is revolutionizing heart disease prevention, enabling timely diagnosis and treatment for patients around the globe.
We’re growing fast and looking for a talented Head of Clinical Ops to help shape the look and feel of our products. If you’re passionate about creating amazing user experiences and want to make a big impact, this is a great chance to work on something global, backed by top-notch investors and exciting achievements.
Your Role
As the Head of Clinical Operations, you will do:
- Lead the clinical affairs function, achieving stated goals and ensuring that clinical trials are conducted per protocol, in a timely fashion, and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and established study budgets
- Clinical study design and execution: Be responsible for the development and execution of multiple clinical trials and research efforts, including supporting start-up activities, enrollment, site management, data collection, data reviews, site feasibility, etc.
- Support data generation strategy and clinical evidence generation: Work closely with product, R&D and commercial team to identify the high-priority areas for data acquisition, clinical evidence generation, understand core medical and scientific literature and ensure the clinical development strategy is in line with the company's commercial positioning. Provide medical/scientific support and content expertise in the design and development of customer solutions, presentations, publications and other collaterals.
- Clinical lead on regulatory submissions: Guide medical and scientific direction in the preparation and submission of regulatory dossiers, as well as serve as the medical / scientific representative at regulatory meetings as appropriate.
- KOL engagement: Map out KOLs in the relevant areas, engage and consult to guide the drive the development of our clinical development strategy.
- Scientific Writing and Publication: support the publication strategy as well as the manuscript writing and publication process.
Requirements
- M.D. or Ph.D. in medical or biology related field
- 5+ years of work experience in driving cardiology-related clinical studies or clinical evidence development for diagnostics or medical device
- Extensive knowledge in clinical study design and protocol writing including IRB writing and biostatistics
- Strong project management skill with attention to detail and experience translating detail to execution of clinical strategies
- Experience in building and managing relationships with KOLs
- Excellent communication skill and ability to work collaboratively with cross-functional teams
- Excellent manuscript writing skills
- Experience in clinical software and medical device, preferred
- Strong knowledge of regulatory requirements governing clinical studies (HIPAA, GCP, FDA)
- A plus: Certification or coursework in clinical research/trial management
- You have excellent scientific written and oral communication skills, as well as interpersonal, organizational, and project management skills
Benefits
🚀 Be part of one of the most disruptive startups in HealthTech and AI and make a difference
🏆 Personal and professional growth as part of a fast-growing, international team
🎧 No corners cut in having the best tech equipment to do your job
🌍 Enjoy a dynamic remote work setup that allows you to connect with our Madrid office, giving you the freedom to work from home 70% of your week or more!
📚 Learning and development opportunities and training budget
💸 Flexible Remuneration
👩🏻⚕️ Health Insurance
🌴 23 holidays, your birthday off, and December 24th and 31st half days to celebrate!
😎 Regular team events and Thursday happy hours
And much more!
