Clinical Scientist Opthalmology at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 140 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Ophthalmology Department is currently looking for a Clinical Scientist (full-time) to join our team.
The Clinical Scientist is responsible for providing clinical development direction and guidance at the project and study level in support of studies within the Ophthalmology Franchise. He/she will collaborate with internal and external stakeholders to plan, implement and manage clinical research studies to ensure trial integrity and success. Responsibilities include providing scientific input to support clinical development, including evaluating and interpreting clinical data, reviewing and authoring study-related documents, delivering protocol-related training to CROs and clinical trial sites, supporting external development meetings, and maintaining knowledge of therapeutic areas of interest. The clinical scientist will be a key contributor to cross-functional project teams focused on development of rare ophthalmic diseases.
Location: Leiden, Netherlands or Boston, US.
Line Manager: Dr Aniz Girach, Chief Medical Officer
- Work on the scientific content on all aspects of clinical trial design and preparation, as well as analyses of data generated.
- Lead/contribute to the authorship of clinical trial protocols, protocol amendments and informed consents, lead/contribute to clinical study reports, publications and presentations, coordinate advisory boards; lead/contribute to regulatory filings including investigator’s brochures, briefing books and responses to questions from regulatory agencies
- Review clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from a clinical perspective
- Participate and/or lead team meetings as required
- Work closely with the Clinical Research Physician to interface with project team members including clinical operations, data management, statistics, drug safety, regulatory and project management
- Be the key contact for relationships to external experts and key opinion leaders, and provide regular scientific-medical disease state updates
- Monitor activities related to the clinical development program, including achievement of key program milestones within the planned time lines and budget
- Demonstrate a working knowledge with company standard operational procedures (SOPs), ICH/GCP guidelines, FDA regulations and regulatory requirements
- Communicate clinical research strategy, plans or results (e.g. abstract preparation, manuscript preparation and presentations at scientific congresses or advisory boards)
- Perform ongoing review of study data and support of the Medical Monitor in the analysis and reporting of clinical trial data
- Develop and present protocol training for CROs and trial sites
- Engage with trial sites and CROs on an on-going basis to monitor patient data and data collection status, ensure adherence to the protocol, and evaluate consistency of data
- Maintain knowledge of the therapeutic area, current medical practice and pharmaceutical regulations to help ensure best practices
- Prepare literature reviews as needed
- Bachelor required; MS, MD, PhD or PharmD preferred
- 5+ years related clinical experience in the Biomedical or Pharma industry
- Extensive clinical research knowledge and understanding of clinical trial methodology
- Excellent verbal and written skills
- Analytical thinking with ability to present data to a variety of audience
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Therapeutic area experience in Ophthalmology preferred
- Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data, and ability to identify discrepancies in clinical trial data and to write queries from a medical perspective
- Experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure and patient narrative
- Ability to understand clinical trial publications and understanding of disease
We offer an exciting and innovative working environment in a very committed organization, with competitive benefits, including an annual performance bonus, stock options, flexible working arrangements and unlimited (un)healthy snacks and drinks.
In hiring new ProQRians, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Do you want to be part of our devoted team of enthusiastic professionals? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible but before 25 February 2019 if you are interested in this position.
You can contact Laura Faber if you have any questions.
Please note that a screening is part of our selection procedure.