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 160 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 Clinical Development Department is looking for a Senior Director Clinical Research
Purpose of the job: To ensure that scientific/medical direction and guidance is provided at the project level and study level in support of clinical trials/programs, in close cooperation with the responsible medical monitor. Lead/coordinate/contribute to all clinical development activities.
Roles and Responsibilities:
• Lead development of clinical study designs
• Lead development of essential documents (incl. protocol, IB, study reports etc.)
• Ensure development of (interim) statistical analysis plan/process
• Lead data analysis and interpretation activities for interim data reviews, interim analysis and main (primary) analyses and prepare data presentation to internal and external stakeholders.
• Support translational activities: interpret preclinical data and apply to clinical program (incl. clinical design development/ clinical monitoring etc.)
• Support in ongoing medical review and interpretation of clinical data
• Validation of novel clinical outcome measures as clinical endpoints
• Liase with collaborators, external experts etc. to accumulate clinical and scientific knowledge necessary to support the clinical development plans
• Coordinate advisory boards on matters related to clinical development
• Maintain knowledge of therapeutic area and current medical practice
• Collaborate in CRO selection and feasibility assessment
• Communication of clinical research strategy, plans or results internally and externally (e.g. clinical data support of abstract preparation, manuscript preparation, presentations at scientific congresses or advisory boards)
• Develop and present protocol training for CROs and sites
• Prepare literature reviews as needed
We expect our new Director to have:
• MSc/MD or PhD with >5 years’ experience in clinical development, preferably in Ophthalmology
• Excellent communication skills - verbal, presentation, and written (English is a must,)
• Demonstrated ability to work in a cross-functional global environment
• Knowledge of clinical trial design, basic statistics, and data review tools
• Strong data review and interpretation skills
• Experience in protocol design and development, study report preparation, Investigator´s Brochure preparation, and preparation and review of other study related documents
• Full understanding GCP and ICH Guidelines
• Aptitude for teaching
• Strategic, able to promptly identify issues and proactively propose solutions
• Able to work with remote colleague
Skills and competencies that are required for making the difference:
• Flexible and resistant to change
• Hands-on mentality
• Autonomous and coachable
• Strong project planning and management skills
• Being able to prioritize multiple tasks
• Excellent communication skills
• Pro-active and pragmatic self-starter, with a result-oriented mindset
• Excellent knowledge of spoken and written English
• A nice person :-)
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
• A competitive salary
• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible but before September 30th if you are interested in this position.
You can contact Femke Hekelaar via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.