About Us: Ownmed Innovation is a pioneering medical device spin-off dedicated to revolutionizing the quality of life for patients with ostomy conditions. Our flagship product, Ostofix, is set to revolutionize ostomy care, providing enhanced comfort, functionality, and quality of life for patients. We are committed to advancing healthcare through cutting-edge research, development, and collaboration.

Job description: Ownmed Innovation is seeking a highly skilled and innovative Chief Scientific Officer (CSO) to lead the scientific and clinical development of Ostofix. The ideal candidate will be responsible for coordinating and overseeing all aspects of clinical trials. This includes study planning, managing participating centers, and supervising patient recruitment and monitoring. This position requires knowledge of clinical trials, and regulatory affairs.

Responsibilities:

Ensure the ethical and efficient execution of the clinical trial, guaranteeing compliance with protocols and the quality of collected data. She will provide comprehensive coordination of the clinical trial alongside the CRO, from planning to implementation. This includes designing the trial protocol to align with ethical and regulatory standards, directly supervising technical tasks related to the evaluation of the device's safety and functionality and analyzing and presenting the results accurately and comprehensibly.

• Oversee the design and implementation of preclinical and clinical studies to ensure robust and reliable results.
• Design and oversee clinical trials to assess the safety, efficacy, and cost-effectiveness of Ostofix, ensuring alignment with ethical and regulatory standards. 
• Review and coordinate the approval of clinical trial protocols and their amendments.
• Analyze clinical trial data and present findings to internal and external stakeholders.
• Participate in the selection of CROs and oversee the activities of contracted CROs.
• Supervise the quality of participating centers in the studies.
• Review documentation related to the development and monitoring of trials.
• Ensure the integrity and scientific rigor of all clinical studies.
• Collaborate with cross-functional teams, including engineering, regulatory, and quality assurance, to drive product development.
• Ensure compliance with regulatory requirements, including CE marking, FDA approval, and other relevant certifications.
• Develop and maintain relationships with regulatory agencies and key opinion leaders.
• Oversee the preparation and submission of regulatory documents and filings.
• Support business development efforts by providing scientific expertise and insights.
• Collaborate with the commercial team to ensure alignment between scientific and business objectives.
• Represent Ownmed Innovation at scientific conferences, industry events, and with potential partners.

Requirements:

• Proven experience in a leadership role within medical device product development.
• PhD in a relevant scientific discipline (e.g., biomedical engineering, biochemistry, pharmacology).
• Experience in medical product development, with a focus on clinical and regulatory affairs.
• Comprehensive knowledge of regulatory requirements (CE, FDA) and clinical trial design.
• Excellent leadership, communication, and interpersonal skills.
• Ability to think strategically and execute with precision.
• Strong analytical and problem-solving abilities.
• Excellent English and Spanish written and verbal communication skills.

Preferred Qualifications:

• Experience managing Phase II and III clinical projects is preferred.
• Experience in ostomy care or related medical fields.
• Previous experience as a CSO or similar leadership role in a medical device company.
• MSc in Medical Affairs.
• Demonstrated ability to build and lead high-performing teams.

What we offer:

• Competitive salary.
• Full-time position with a hybrid in-person and remote work format.
• Opportunity for professional growth and development.
• Dynamic and collaborative work environment fostering innovation and creativity.
• The chance to contribute to pioneering medical device technology impacting patients' lives.

Application Process: if you are passionate about making a difference in patients' lives through innovative medical devices and possess the skills and qualifications mentioned above, we invite you to apply and become a valuable part of our team at Ownmed Innovation.

Interested candidates should submit their resume, a cover letter outlining their qualifications and vision for the Ostofix project to [email protected] with the subject line "CSO Application - [Your Name]." Shortlisted candidates will be contacted for interviews. 

Application Deadline: 30^th of September of 2024 

Join Ownmed Innovation and be part of a team dedicated to transforming healthcare and improving the lives of patients with ostomies.