Madorra is a growing medical device and consumer health company addressing a critical unmet need for breast cancer survivors and postmenopausal women: vaginal dryness. We have developed the first non-hormonal, non-invasive medical device to treat this condition, which affects tens of millions of women. The best treatment options today are all hormone-based, which many women cannot or refuse to use because of the serious side effects and long-term risks. Join an exciting, fast-paced and motivated team to usher in a new era of women’s health!
Position Summary
The individual in this role will lead Madorra’s clinical research activities in support of the FDA approval of the company’s flagship product. This role will work closely with the CEO, R&D team, and collaborating research sites (locally, around the US, and overseas) to meet the clinical research and business objectives.
Core Responsibilities
Work with a cross-functional team to design the company’s next-stage clinical strategy and clinical studies, in close collaboration with the Madorra Scientific Advisory Board
Manage clinical trial execution and compliance (both inside the company and with Contract Research Organizations)
Cooperate with the Principal Investigators and site research staff to manage efficient study operations
Implement local clinical stud visits and manage internal data collection
Create and maintain compliance and regulatory dossiers to meet US and international requirements
Support regulatory filings with the FDA and other notified bodies
Provide scientific interpretation of safety and efficacy data and provide recommendations for clinical strategy
Desired Education, Experience, and Capabilities
Bachelors in a life sciecne or other scientific discipline (e.g. Biology, Chemistry, …)
5 – 10 years of clinical or pre-clinical research experience in medical devices
Scientific acumen and literature synthesis skills
Attention to detail
Excellent written and verbal communication
Experience in women’s health or start ups a plus!
If you’re interested in applying, please send your resume and an email describing why you’re a good fit for the position to info@madorra.com.
