🎶 About Poppins 🎶

Poppins mission is to unlock the potential of children with learning difficulties by developing medical devices for children with neurodevelopmental disorders.

On a daily basis, families of children with learning difficulties (dyslexia, dyspraxia, dysphasia, ADHD, etc.) are faced with a shortage of healthcare professionals, resulting in an average waiting list of 18 months and an insufficient frequency of therapeutic exercise. It is also an educational issue as these disorders have such an impact on these children's schooling and self-esteem.

We developed Poppins' Musical Adventure, a CE-marked medical device software that uses rhythmic stimulation to provide early support and improve continuity of care. On the child's side, thanks to the support of our strategic investors and partners (Warner Music Group, Sony, Concord, Disney), the product is a video game based on a strong use of music to create a rich, non-medical and non-stigmatising experience for the child. On the parent's side, the product provides close support to make this obstacle course easier and more fluid.

Poppins is a team of 33 diverse backgrounds in medicine, video games and patient experience, committed to achieving universal access to care for pediatrics. Since its inception in late 2018, we have built a product that has been CE marked, evaluated in 3 scientific studies with 7000 families and a double-blind placebo-controlled pivotal clinical trial, endorsed by 5 large insurers in the market, and earned a reputation as a reliable partner in the ecosystem. Backed by leading healthcare and digital funds, we strive to be the trusted reference for children's neurodevelopmental disorders.

🎶 Your mission 🎶

We are seeking a Director of Clinical Affairs to manage our clinical strategy demonstrating strong evidence for the Poppins' product enabling better market access. The successful candidate will be responsible for designing and implementing clinical studies as a sponsor or as a vendor, providing leadership to the clinical team, ensuring seamless clinical trial operations, while ensuring compliance with all regulatory requirements.

Essential Duties and Responsibilities

1. Responsible for developing and overseeing the clinical strategy in accordance with the company’s strategy
2. Responsible for overseeing the clinical operations from design, implementation to reporting of clinical trials that meet the highest standards of excellence for ethics, scientific merit, and regulatory compliance. You will manage the following (non-exhaustive list):
   • Supervises the development of protocol, implementation, and management of the process.
   • Plan and execute clinical trials while ensuring compliance with applicable regulations, standards and procedures, company SOPs, project plans and timelines.
   • Full management for clinical trials - data analysis, monitoring, in person management, manuscript writing.
3. Support market access strategy by being the POC for all clinical questions from the payers or regulators to introduce Poppins' products on the market (UE, US, others). You will work with RAQA and Market Access teams.

Requirements

• At least 5 years of experience in managing clinical activities for innovative digital products in a start-up environment.
• Proven track record of delivering successful trials that meet regulator and payers needs and drive business growth.
• Strong leadership and management skills, with the ability to inspire and motivate a team.
• Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Interested in cutting-edge technology, software and in the medical device industry
• Strong experience in the US and UE markets
• First experience on European and US medical devices markets and on the main regulatory and reimbursement pathways for US and EU market

🎶 As for you 🎶

Beyond your skills, training or experience, we are looking for a personality.

It would be a good match between you and Poppins' mission if:

• You are curious, like to learn and try new things, even if you fail;
• You are able to take on a project or goal and see it through to completion quickly;
• You are enthusiastic about working in a team and value transparency above all else;
• You care deeply about people.

Benefits

🎶 Poppins offers a challenging and fulfilling work environment. 🎶

That is why we offer:

• The opportunity to be part of a team of around twenty passionate people with a triple aim: social, medical and educational. We're motivated by the testimonies of the parents and the children we're privileged to work with on a daily basis.
• A team with a strong sense of community.
• A flexible and remote-friendly working environment, with regular face-to-face rituals to nurture our collective dynamism.
• Excellent health insurance with Alan fully covering you and your family; an unlimited Gymlib subscription for physical activity; and a budget for coaching and psychological support through Moka.Care to take care of your mental health.
• BSPCE for all
• Meal vouchers (Swile), transport and the necessary equipment to enable you to do your best work.

🎶 The application process 🎶

Applications are processed as they come in. Estimated time for the whole process less than 3 weeks:

1st call (20mn) → 2 short individual interviews with team members (1h to 1h30 in total) → Technical test & debrief (45mn) → Interview with founders (45mn) → Welcome onboard! 🎶

🎶 Before applying 🎶

You can read this (beautiful) visual presentation on our company 😊