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.
To join our team ProQR Therapeutics is currently looking for a
SENIOR DIRECTOR CLINICAL DEVELOPMENT
- Reports to: Chief Medical Officer, or designate
- Location: Leiden (Netherlands) or Boston (USA), with some travel involved.
This is an excellent opportunity to join a well-funded Biotech company that has attracted a world-class management team where you will be responsible for directing all aspects of the design of clinical studies, helping with implementation of clinical trials, and preparation of reports relating to clinical trial outcomes.
- Support the clinical-stage programs, such as in LCA10 and Usher Syndrome, and bring forward other pipeline programmes into the clinic
- Show awareness and ability to link the late stage preclinical programmes with what would be needed in the clinic
- Help formulate and provide input into early phase clinical development programmes, including recommendation of primary and secondary end points, biomarkers and inclusion/exclusion criteria with the view of gaining regulatory approval
- Direct all aspects of activities relating to preparation of protocols, clinical trials, data analyses, safety evaluation and clinical study reports, including being the medical monitor for clinical trials
- Execute medical review of individual case safety reports and aggregate safety data, and participate and contribute to safety surveillance activities, safety processes and safety development
- Show communication and ability to form strong relationships with Ophthalmology KOLs
- Collaborate with key stakeholders to ensure that the clinical aspects of protocol/trials are properly executed
- Provide guidance on feasibility assessment and investigator/site selection
- Interact with CRO and other vendor relationships
- Provide support for Competent Authority and Ethics Committee/IRB submissions
- Review periodically clinical data and present them to internal and external audience including DMC meetings and investigators’ meeting
Education and experience required
- Professional credentials as a physician (MBChB or MD) or equivalent (e.g. PhD, OD)
- Significant experience (minimum of 3 years) of clinical development
- Experience in ophthalmology preferred
- Experience working in small biotech/start-up and/or rare diseases an advantage
- Experience in leading and managing project teams and managing multiple projects concurrently
- Thorough knowledge of clinical trial approval processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP)
- Excellent oral and written communication skills as well as the ability to facilitate analysis and problem solving through the effective facilitation of group activities
- Strong organizational and time management skills including the ability to function effectively in a team environment
- Demonstrated professionalism and adherence to high ethical standards
- Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a “hands-on” fashion
- Demonstrated experience within the biotech/pharma industry in clinical development, including designing and executing clinical studies
- Experience or familiarity with innovative and adaptive trial designs is desired
- Capacity to thrive in a dynamic and fast-paced environment
We offer an exciting and innovative working environment in a very committed organization, with competitive benefits, including an annual performance bonus, stock options and flexible working arrangements. The salary and terms of employment will be discussed in detail at an appropriate stage of company interview.
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.
Please apply as soon as possible if you are interested in this position.
You can contact Laura Faber via firstname.lastname@example.org if you have any questions.
Keywords: Vacancy, Biotechnology, Physician, MBChB, MD, PhD, OD, MSc, Leiden, Zuid-Holland.