Senior Director Clinical Research Ophthalmology

Location
Leiden
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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 recruitment@proqr.com if you have any questions. 
Please note that a screening is part of our selection procedure.