Ofertas de empleo en Zoundream

• Nivel de experiencia---
• Tipo de contratoA tiempo completo
• PublicadaNueva

.

2 days ago Be among the first 25 applicants

Direct message the job poster from Zoundream

We are Zoundream, a dynamic, growing, and ambitious startup developing the world's most advanced technology for infant voice analysis, powered by Artificial Intelligence (AI) and sound recognition.

We are a passionate, multidisciplinary team of scientists, engineers, and product visionaries, and our mature core technology is the world leading solution for the analysis of infant voice, trusted and used by the major juvenile brands worldwide (e.g., Philips Avent, Maxi-Cosi, Motorola Nursery).

By analyzing newborn cries and vocalizations, Zoundream delivers powerful, actionable insights, not only interpreting infants' real-time needs or emotions, but also flagging critical risk patterns that serve as early indicators for health assessments.

The Role

Currently, we are expanding our team to reinforce a groundbreaking project aimed at supporting early detection of pathologies and neurodevelopmental conditions through infant voice analysis.

With ongoing projects in collaboration with multiple large corporate customers and hospitals worldwide, we are seeking a proactive, versatile, autonomous, and motivated Clinical Lead to champion our clinical strategy and regulatory landscape in order to bring our technology to market as a medical device, providing innovative digital health to every home.

This is a leadership role that requires a unique combination of deep clinical expertise, scientific rigor, and a startup mindset.

As a core member of the executive team, you will shape the clinical roadmap alongside Product, R&D, and Engineering, ensuring our technology is safe, effective, and addresses a critical unmet need; making it a must-have solution for families.

What You Will Do

Engaging in proactive collaboration with hospitals, research institutions, healthcare providers, consultants, and regulatory bodies (e.g., FDA, MDR/CE, notified bodies) to promote research initiatives, define the clinical roadmap strategy, and ensure clinical validation, regulatory approval and market adoption.

Ensuring all clinical and software development activities comply with relevant medical, ethical, and data-protection standards (e.g., MDR, ISO *****, IEC *****, HIPAA, HL7/FHIR).

Leading or supporting the creation, implementation, and continuous improvement of the company's Quality Management System (QMS), including drafting SOPs, coordinating internal audits, and implementing ISO ***** certification.

Designing and managing clinical trials in collaboration with clinical sites, academic collaborators, and Contract Research Organizations (CROs), including the preparation and oversight of associated documentation, requests, and processes (e.g., protocols, informed consent forms, contracts, budgets, patient safety measures and logistics, IRB guidelines, ethical committees submissions).

Overseeing and monitoring the progress, quality and data collection of multicentric clinical trials using EDC tools such as Castor or REDCap.

Collaborating cross-functionally with data scientists, engineers, software developers, and external partners to align clinical and research objectives with product development goals.

Working closely with the R&D team on the clinical strategy, hypothesis definition, statistical analysis plans and interpretation of clinical results with scientific rigor.

Contributing to the establishment and management of the Scientific Advisory Board, including recruiting members, organizing events, and facilitating meetings to drive collaboration.

Building strategic partnerships with hospitals, Key Opinion Leaders (KOLs), and healthcare networks to expand validation, visibility, and market trust.

Representing the company in scientific and industry events, aimed at identifying emerging trends, fostering collaborations, and enhancing the visibility and adoption of our technology within the healthcare ecosystem (e.g., hospitals, telemedicine platforms, and insurance providers).

Which Skills Are We Looking For (Must-Haves)

Qualifications & Experience

Doctoral degree (PhD) and/or Medical Degree (MD) in Biomedical Sciences, Bioengineering, Biotechnology, Health Sciences, Epidemiology, Statistics, Neuroscience, Neuropsychology or related field.

Specialization and clinical experience in Pediatrics, Neonatology, Developmental Psychology, or Pediatric Neurology is a strong plus.

Proven experience (= 10 years) in clinical research and medical technology validation, ideally involving digital health and Software as a Medical Device (SaMD).

Experience with a successfully approved SaMD already in the market is a plus.

Fluency in English (both written and spoken) is required, as you will be part of an international and multicultural team.

Required solid background in regulatory frameworks (MDR/CE and FDA) and quality systems (e.g., ISO *****, ISO *****) in the clinical validation and medical device ecosystem.

Demonstrated experience in designing, managing, and executing ambitious research projects, multicentric clinical trials or observational studies, including collaboration with CROs and hospital research units.

Proven ability to manage relationships with external stakeholders: hospitals, investigators, advisors, KOLs, notified bodies, regulatory consultants, CROs, ensuring alignment and quality in execution.

Experience preparing regulatory and clinical documentation, protocols, informed consents, statistical analysis plans, and reports ; with a strong attention to scientific rigor and compliance standards.

Innovative thinking able to propose and execute new strategic ideas in digital health and medical device integration, identifying research trends and partnerships aligned with the company's long-term goals.

Track record of identifying and pursuing funding opportunities (e.g., grants, go-to-market, alliances, reimbursement programs) is a plus.

What Type of Person You Are

Highly self-motivated and proactive, always looking for new tasks and challenges, bringing enthusiasm and inspiration with a solution-driven approach.

A "player-coach" mentality, capable of high-level strategy and hands-on execution.

Autonomous, organized and able to work with minimal guidance, ensuring deadlines and prioritization, with strong attention to detail and a structured mindset.

Ambition attitude with effective multitasking and time management skills.

Adaptable to change, versatile and excited to embrace risks and disruption in a dynamic environment.

Eager to embrace startup culture and thrilled to contribute to the success of innovative, high-impact technology changing the world.

Driven by a passion to make a meaningful impact, committed to advancing science and improving healthcare and society.

Most importantly: you are a great team player and networker who thrives in a collaborative, vibrant environment.

What We Offer

The opportunity to be part of a high-tech, mission-driven startup at the forefront of global infant voice analysis technology using advanced AI and sound recognition.

Work with a passionate, ambitious, and diverse team dedicated to redefine infant care through technology.

A collaborative, innovative and dynamic environment with direct influence on product development and company direction.

Opportunities to grow professionally contributing your ideas and innovations while taking on new challenges and responsibilities.

Play an impactful key role in developing and improving products that directly impact patients' lives and drive advancements in healthcare.

Flexibility to maintain a healthy work-life balance.

A Highly Competitive Compensation Package

Salary range: €65,000–€85,000, aligned with your experience and expertise.

Generous stock options plan, to share in the company's success and growth.

Do not hesitate.

Join us and let's revolutionize the future of infant care together!

To Apply: Please submit your CV detailing your relevant experience to ******

#J-*****-Ljbffr