Job Description

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

🙋 Unlimited remote working environment, where you can choose to work from home and attend our Madrid office whenever you want to

📚Learning and development opportunities and training budget

💸 Flexible Remuneration

👩🏻‍⚕️ Health Insurance

🏋 Access to Wellhub (Gympass), empowering your physical and mental wellness!

🌴 23 holidays, your birthday off, and December 24th and 31st half days to celebrate!

😎 Regular team events and Thursday happy hours

And much more!

At IDOVEN, we believe in hiring top talented people like you - ambitious, forward thinkers who want to make a difference in the world and have an impact.