Clinical Development Lead (Manager or Director) US

Boston, MA /
Clinical Affairs /
At Cardiologs, our mission is to make tomorrow’s medical diagnosis efficient and accessible to everyone, anywhere, anytime. We leverage machine learning (AI) and cloud computing technologies to fulfill this vision. Our first product is a SaaS application to help physicians diagnose cardiac diseases, already deployed worldwide.

We are a small Boston based team conveniently located off of the Charles/MGH Red Line station. We nurture our company culture with biweekly all-hands meetings and various office events that include lunch, dinner, and drinks. Most importantly, we believe that a good atmosphere at work makes people more efficient in what they are best at, so we hope you'll bring your own energy to our office.

What you’ll do

The Clinical Development Lead provides clinical leadership and acts as an expert to develop the clinical strategy for new and existing products.

The position will lead the regulatory clinical testing activity. You will design clinical studies towards product development and registration, drive medical value innovation and clinical differentiation of Cardiologs products.
You will act as a cross-functional advisor across Cardiologs functions and will partner with internal and external experts in clinical operations, R&D, data science, biostatistics, regulatory affairs, product, and marketing.

This person will report to the VP of Clinical affairs.

Also, you will:

- Create evidence generation plans, including clinical trials and design/implementation of protocols to satisfy Cardiologs clinical program plans
- Lead FDA GCP activities and guide strategy for regulatory clinical testing
- Develop the clinical parts of regulatory file submission including Clinical Protocol, Clinical evaluation Report, Investigator brochure
- Be responsible to write US, EU (and global) clinical plans and clinical reports
- Develop acceptance criteria for FDA analysis and performance validation
- Be the point of contact for clinical questions raised by the FDA
- Design clinical studies towards product development, enabling a successful Clinical Evaluation Plan which meets the requirements of regulatory authorities
- Support R&D teams with establishing product benefits and ensuring adequate Risk Analysis 
- Review proposals for Investigator-Initiated Study (IIS) and make Go/ No Go recommendations. Develop IIS plans with KOLs and research center. Ensure IIS execution timing.
- Partner with KOLs, Research Centers, and Marketing to drive clinical evidence generation activities that address value proposition.
- Lead clinical evidence dissemination and presentation to Marketing and other teams. Review and edit manuscripts and abstracts in collaboration with the broader team and KOLs
- Participate in global HCP advisory board meetings, leading clinical/medical discussions. 

Who you are

- An autonomous, enthusiastic, and reliable holder of a master's degree or Ph.D. in biomedical science
- You have a minimum of 8 years of experience in clinical research.
- You already have extensive experience in designing and executing clinical studies- You have solid experience in FDA studies.
- You already have experience in developing and implementing clinical evidence strategies to support regulatory approvals in the US (and EU): protocol, report writing, clinical rationale, acceptance criteria …
- You have some knowledge of industry standards and best practices in clinical evidence generation, US Code of Federal Regulations, ISO 14155, ICH GCP, ISO 14971, EU MDR.
- You have experience of interaction with regulators (e.g. FDA, Notified Bodies, Competent Authorities…)
- Knowledge of statistical methods will be helpful
- You're able to present scientific content to diverse audiences required
- Fluent in spoken and written English. French would be a plus.

+ An experience in digital health will be preferred
+ A digital health experience would be helpful

Our Recruiting Process
Being authorised to work in the US is a precondition of employment.

- Quick introductory HR phone call
- Technical interview in our office or by Zoom
- Performance interview in our office or by Zoom
- Culture interview (with lunch or drinks with the team if possible!)
- Quick call with our CEO, Yann (only if you did not have the opportunity to meet him in one of the previous interviews)
- Reference calls