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Medical Program Manager

1 month ago

Montréal, Canada Noze Full time

**Who we are**:
Noze has digitized the sense of smell. We've done for the nose what the camera did for the eyes and the microphone did for the ears. It took six years and some help from NASA but we did it. Now it's time for us to bring it to the world.

Are you interested in working to help implement Noze's technology in the medical/clinical domain? People who succeed at Noze have a sense of urgency, a ton of initiative, infinite curiosity, strong internal drive, and an enthusiasm for bleeding edge tech. If you're bursting with fresh ideas and want to join a company in its journey to change the status quo, then this opportunity is for you

**Who you are**:
You are a highly motivated and experienced Medical Program Manager ready to join our team and lead the clinical trial and compliance initiatives for our breath-based diagnostic devices. You will play a critical role in ensuring the success of our clinical trials and the compliance of our products with regulatory requirements. You are capable of ensuring that our clinical studies are executed with rigor in terms of protocols, approach, conduct, data management, data processing, results reporting and oversight of core team activities. Finally, relationship management comes naturally to you in order to build and nurture relationships with our clinical study partners and other stakeholders.

**What You Will Do**:

- Lead a cross-functional team to design, develop and deliver medical/clinical projects, centered around our breath-based diagnostic devices, while adhering to statutory medical device requirements.
- Develop and manage clinical trial protocols, informed consent forms, study case report forms, and other trial-related documents in accordance
with regulatory requirements
- Develop and implement processes for monitoring the safety and efficacy of our devices during clinical trials.
- Ensure that clinical trial data is accurately recorded, analyzed, and reported in accordance with regulations.
- Prepare and participate in meetings with regulatory agencies, including pre-submission meetings, end-of-phase meetings, and pre-approval inspections.
- Create and own a medical project working group that includes your team and key stakeholders from Noze's technology team to build a medical product roadmap.

**What you need**:

- Advanced degree (e.g., Master degree, MD, PhD) in Biomedical sciences, Pharmacy, Pharmacology, RN or an equivalent combination of education, training and experience.
- 5 plus years of managerial experience in leading clinical study projects and teams using medical device technologies
- Independent On-site monitoring experience.
- Experience in the full life cycle of medical device based clinical trials including but not limited to data, project, team, stakeholder and delivery management.
- Strong understanding of the regulatory environment.
- Strong attention to details and organizational skills.
- Ability to plan, multitask and work in a dynamic team environment
- Communication, leadership, and problem-solving skills

**What we offer**:

- The opportunity to join a forward-thinking company surrounded by a collaborative team of innovative thinkers;
- A rewarding career path with diverse opportunities for professional growth;
- A competitive compensation and benefits package including employer paid health and dental benefits for eligible employees;
- A generous learning and development budget to attend conferences, classes and other professional development events;
- A bunch of other perks that involve food, fun and travel.

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