Core purpose of the job
Supporting quality and timely execution of pre-clinical and clinical studies through operational management.
Management of all operational aspects related to the study conduct.
Coordinate and supervise activities of multi-functional study team members.
Reporting to the Chief Medical Officer.
- Degree in scientific disciplines (Medicine, Biology, Pharmacy or Chemistry)
- Deep knowledge and understanding of drug development process, ICH/GCP guidelines
- Solid experience in study management (> 5 years) and ability to coordinate multi-functional study team members by regular tracking of activities to ensure timely and quality data delivery
- Experience in vendors’ selection, contacting and oversight is highly desired
- Budget optimization and cost control attitude
- Strategic support in countries/sites selection with deep understanding of operational implications such as recruitment timelines, site experience and ability to comply quality standards
- Contribute to the development of regulatory documents, responses to Health Authority, EC/IRB and DSMB questions
- Plan, organize and lead Investigator meeting and CRA training & review related material
- Perform ongoing ESP management, performance management and issue resolution Oversee monitoring activities and conduct co-monitoring visits to ensure data quality
- Coordinate pre-audit and CAPA resolution activities ensuring satisfactory outcome
- Adhere to personal development plan and maintain training records to ensure appropriate level of competence in compliance with this job description including GCP, etc
- Previous experience with clinical development of biologics
- Previous experience with GLP-preclinical studies is a big plus.
- Strong motivation and ability to achieve assigned objectives, timely and with high quality standards
- Organized and used to set KPIs to regularly track activities
- Excellent communication skills, verbal and written
- Ability to work in challenging and rapidly evolving situations
- Proactivity and problem-solving attitude
- Excellent team player
- Personal resilience, perseverance, energy and drive
Fluent in English (spoken and written).
Enthera is a biotech company building a pipeline of first-in-class biologics for several under-served autoimmune conditions, with a focus on Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD). Our aim is to develop disease-modifying treatments by preserving and re-establishing cell and organ function to revert the outcome of these conditions
Our pioneering approach is to target IGFBP3/TMEM219, a novel stem cell apoptosis pathway involved in the development and progression of several autoimmune conditions.
By targeting the IGFBP3/TMEM219 axis and its dysregulation, we aim to provide safe and effective therapeutics for autoimmune diseases with high unmet medical need.
Our current focus is the in-house development of two clinical candidates. Ent001, our lead program, is the only drug in development with the potential to preserve and restore the endogenous pancreatic beta cells compartment in T1D as well as the original intestine structure in IBD, in order to re-establish organ function.
Our passionate management team brings multi-disciplinary expertise and a proven track record in drug development and Investigational New Drug and Marketing Authorization approvals. Founded in 2016, we are funded by BiovelocITA, Sofinnova Partners, AbbVie, Roche, JDRF and a number of private investors.
Applications must address the selection criteria above and include a current CV and covering letter.
Send your application to firstname.lastname@example.org, message subject “Clinical Trial Leader”.