Director Clinical Operations
Director Clinical Operations
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1 Vacancy
Job Description
ProQR Therapeutics is a biotechnology company listed on NASDAQ with offices in Leiden the Netherlands and Cambridge Massachusetts USA. ProQR is focused on the development of life changing RNA therapies to meet the unmet need of individuals and families with common and rare diseases. A team of 150 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 communities we serve. Our proprietary Axiomer RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA) which is machinery present in all human cells to repair GtoA mutations modulate protein and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases.
We have several programs in earlystage development as part of our Axiomer RNA editing platform. Our way of working involves a combined approach of inhouse expertise and fully outsourced GxP Activities. We are currently looking for a Director Clinical Operations (DCO Fulltime) to build our clinical operations capacity. The aim of the position is to structure the clinical operations department and managing the team of clinical operations leaders. The DCO will provide strategic and technical leadership to ensure that clinical trials are properly planned and executed to ascertain appropriate selection of clinical CROs and other clinical vendors and to drive engagement development retention and adequate resourcing of the Clinical Operations team.
The DCO will be a key member of the cross functional project teams to support definition of the clinical development strategies with a high chance of successful outcomes and good quality results in a highly dynamic and complex environment and in accordance with the appropriate quality standards including GCP/ICH requirements and applicable international and local regulations.
As the DCO is the founder of this department within the ProQR organization we expect the DCO to lead the firstinhuman study for the first clinical target from the proprietary Axiomer Platform in a fully outsourced model.
Key Responsibilities:
Strategic planning and execution of clinical trials
- Develop strategic plans for clinical trials and ensure alignment with corporate goals GCP regulatory requirements quality standards.
- Clinical study planning including site selection vendor selection patient recruitment and site engagement
- Report on status and risks to key stakeholders
Clinical study oversight
- Lead the operational execution of the first in human clinical study
- Oversee & manage operational execution of development clinical trials and ensure execution in line with strategic plans and budget
- Manage timelines budgets CRO partnerships and key stakeholder communications to ensure efficient trial execution
Strategic Team Building
- Develop and execute a plan to build and scale the clinical operations team in line with the companys objectives.
- Recruit and mentor the clinical operations staff to support future clinical programs
Operational Excellence
- Build on processes tools and systems to enhance operational efficiency and data quality
- Collaborate crossfunctionally with regulatory CMC and preclinical teams to advance clinical programs seamlessly
Leadership Development
- Act as a handson leader initially gradually transitioning into a broader strategic leadership role as the team grows
- Contribute to longterm development planning
Requirements:
Experience:
- 10 years of experience in clinical operations including a proven track record in managing (earlyphase) clinical trials
- Excellent understanding of GCP clinical trial methodology clinical trial execution and ICH and regulatory requirements
- Experience in biotechnology and/or pharmaceutical setting with expertise across all stages of Clinical Development
Leadership Skills:
- Demonstrated ability to lead crossfunctional teams and manage external partners (e.g. CROs)
- Able to recognize needs find solutions and take initiative in a proactive manner
- Selfstarter with a strong strategic vision and handson operational expertise
Education:
- Bachelors degree in life sciences or a related field (advanced degree preferred).
Other:
- Excellent organizational project management and problemsolving skills
- Effective verbal and written communication skills (in English) with colleagues leadership with external stakeholders
Location: Leiden NL
Skills and competencies that are required for making the difference:
- Analytical and accurate
- Creative thinker
- Flexible and resistant to change
- Handson mentality
- Proactive attitude
- Teamplayer
- Patientoriented attitude
- Autonomous and coachable
- Being able to work in a fastpace environment
- Strong project planning and management skills
- Being able to prioritize multiple tasks
- Critical thinking decision making and problem solving skills
- Excellent communication skills
- Proactive and pragmatic selfstarter with a resultoriented mindset
- Excellent knowledge of spoken and written English (and Dutch)
- 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 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:
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premiumfree pension plan
- A commuting allowance
- A subsidized staff restaurant
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp Rebel Caf and other social events)
Do you think you can contribute to achieving our mission If so were looking forward to receiving your application by filling out our application form.
You can contact Silvia Catellani via if you have any questions.
Employment Type
Full Time
