Clinical Director

il y a 4 semaines


SoisysurSeine, Île-de-France EndoGene Temps plein

Company Overview:

At EndoGene.Bio, we are committed to revolutionizing women's health by developing innovative diagnostic solutions. Our mission is to reduce the time for endometriosis diagnosis from years to weeks, leveraging proprietary biomarkers found in menstrual blood.

Position Overview:

As a Clinical Manager at EndoGene.Bio, you will play a pivotal role in driving our diagnostic solutions to market. This position requires close collaboration with patient advocacy groups, liaising with doctors and hospital teams, developing clinical protocols, and overseeing sample sourcing. Your expertise will contribute directly to the success and growth of our organisation.

Key Responsibilities:

Clinical Trials & Protocols:

Lead the development and writing of clinical protocols for our diagnostic tests. Oversee clinical studies and trials' execution ensuring adherence to timelines, budgets, and regulatory requirements. Monitor progress of trials and identify potential risks, implementing strategies to mitigate these risks.

Hospital Recruitment:

Cultivate strong relationships with key opinion leaders, physicians, and hospital administrative staff. Recruit and onboard hospitals for clinical trials, ensuring they meet all research criteria. Provide training and resources to hospital teams participating in our studies and trials.

Patient Advocacy Engagement:

Build and maintain relationships with key patient advocacy groups related to endometriosis. Collaborate with these groups to ensure the patient voice is central in our clinical trials and product development. Attend and represent the company at patient advocacy events, conferences, and other relevant forums.

Sample Sourcing Activities:

Manage the end-to-end process of sourcing, collecting, storing, and transporting diagnostic samples. Ensure the highest quality and integrity of samples, adhering to all regulatory and ethical standards. Coordinate with labs, storage facilities, and transportation providers.

Team Collaboration:

Work closely with cross-functional teams including R&D, Regulatory, Quality Assurance, and Marketing to ensure alignment on project objectives and deliverables. Provide periodic updates and presentations to senior management on the progress of clinical projects.

Qualifications:

Medical Doctor (MD) degree, or other degrees + experience in clinical studies in IVD. Experience in Gynaecology preferred. Experience in clinical research or clinical project management, preferably related to diagnostics and gynaecological conditions. Experience working with regulatory guidelines and ethical considerations in in-vitro diagnostic research. Exceptional interpersonal and communication skills, both written and verbal. Ability to travel as needed. Languages required: English, French and Spanish

Location:

Must be based in France or Spain.

Benefits:

Competitive salary. Comprehensive health benefits. Company perks (if on site): transport ticket, meal tickets. Opportunities for professional development. Collaborative and innovative work environment.


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