Vice President Medical Affairs at ProQR Therapeutics
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 eye 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.
ProQR Therapeutics is currently looking for a Vice President Medical Affairs to join our team.
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.
Reports to: Chief Medical Officer
Location: Leiden (Netherlands) or Boston (USA), with some travel involved.
- Oversee the management of all aspects of Medical Affairs, including Medical Strategy, Phase 3b, Phase 4 and Investigator Initiated Trials, KOL Management, Medical Education, Medical Communication, Medical Information, Publication Management and Scientific Services (future MSL organization).
- Support the clinical-stage programs, such as in LCA10 and Usher Syndrome, and help support to bring forward other pipeline programmes into the clinic
- Provide scientific and medical input necessary to support the company's commercial strategy
- Ensure strong coordination and alignment of agreed plans between clinical development and commercial strategy
- Interacting with key opinion leaders (KOLs) and KOL strategy development
- Oversee all aspects of medical communications, education and publications strategy
- Provide training and support to the commercial organization related to clinical aspects of disease areas of interest to the Company and ensure high quality scientific and core message integrity
- Establish and oversee a team of field-based Medical Science Liaisons
- Develop a strategy and execution of phase 3b, phase 4 and post-marketing trials
- Develop lifecycle management strategy for each compound
- Review the scientific and medical value of proposals of Investigator Initiated Studies
- Draft and review materials for medical accuracy
- Oversee all aspects of medical information services
- Support any due diligence and business development activities
- Establish and monitor adherence to departmental processes, procedures and SOPs
- To ensure compliance with ethical and regulatory standards in all Medical Affairs activities
Education and experience required:
- Professional credentials as a physician (MBChB or MD) or equivalent (e.g. PhD, PharmD, OD)
- Minimum of 8 years in the pharmaceutical industry
- Significant experience (minimum of 5 years) in a leadership role in Medical Affairs
- Experience in ophthalmology preferred
- Experience working in small biotech/start-up and/or rare diseases an advantage
- Experience in leading and managing teams and managing multiple projects concurrently
- Thorough knowledge of compliance rules and clinical trial approval processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP)
- Excellent oral and written communication skills
- 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 medical affairs
- 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 email@example.com if you have any questions.