Medical Monitor

ProQR is one of the most exciting and successful biotech companies in the world today. Less than a decade after it’s inception in 2012 the company is NASDAQ listed with a growing market capitalization and an exceptionally strong cash position. ProQR is funded to support its mission to bring new medicines to patients for many years ahead. Fueled by the experiences of the CEO and leadership team ProQR are striving to treat previously untreatable and blinding rare diseases of the eye in both children and adults. The company’s drive to help patients is absolute and resonates throughout the company at all levels, creating a uniquely positive, passionate culture. Over 160 ProQRians from all walks of life and over 30 different nationalities across Europe and US/north America are working tirelessly to achieve these goals.

In 2012 CEO Daniel De Boer assembled a team of experienced industry leaders and began creating RNA therapies for various rare diseases. In the early years it emerged that the company’s scientific platform was most effective in producing ground-breaking treatments for diseases of the eye, specifically inherited retinal diseases. In trials ProQR’s compounds have shown startling results, at times restoring the vision of patients who have lived most of their lives virtually blind. Increasingly the company’s R&D teams, based in the Netherlands/EU, UK and the United States/Canada, are developing programs to treat a range of retinal conditions. With numerous, highly promising treatments in progress it is no exaggeration to say that ProQR has one of the richest, most promising pipelines in the world of Ophthalmology today.

Our clinical Development department is currently looking for a Medical Monitor (Full-time) to join our team.

Responsibilities include:

  • Be ultimately responsible for all aspects of Medical Monitoring for the clinical-staged trials
  • Supervising the CRO Medical Monitoring activities
  • Providing input into the creation of the protocol and other study-related documents
  • Participating in discussions with regulators, key opinion leaders, senior management and other vendors
  • Delivering protocol-specific or therapeutic training to internal/external project teams and colleagues
  • Reviewing medical data on the indication, inclusion / exclusion criteria and other medical issues to ensure our overall project deliverables are achieved
  • Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,)
  • Be responsible for medical input for investigator meetings, kick-off meetings, Data Monitoring Committee Meetings
  • Working closely with our Drug Safety teams to evaluate Serious Adverse Events and to develop Safety Management Plans, Pharmacovigilance Plans and Risk Management Plans
  • Maintains working knowledge of GCP and regulatory requirements relating to clinical development and safety
  • Assuring compliance with ethical, legal and regulatory standards
  • Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.

Qualifications/Experience:

  • Successful candidates for the Medical Director role will be licensed physicians (MD) with at least 2yrs minimum experience in a similar position in pharma/biotech industry or CRO
  • Familiarity with phase II/III projects (either in industry or as an Investigator) along with project management and leadership skills are required. 
  • Strong experience in Ophthalmology is mandatory, experience also in Rare Disease or Gene Therapy is appreciated
  • Strong communication skills in English and a genuine desire to contribute to drug development and patient wellbeing in a commercial environment are necessary. 
  • Excellent leadership abilities
  • 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
  • Capacity to thrive in a dynamic and fast-paced environment
  • Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
  • As we continue to expand, there will be career opportunities on a truly global scale. 

Reports to: VP Clinical Development or designee

Location: Leiden, NL, or Cambridge, Massachusetts, US, or other remote based working.

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
  • 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 on our website: www.proqr.com

Please apply as soon as possible if you are interested in this position.

You can contact Silvia Catellani via recruitment@proqr.com if you have any questions.

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