Kiadis Pharma’s cell-based immunotherapy products can make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective, for an annual target population of 27,800 patients in the US/EU. Single dose Phase 2 data with lead product ATIR101™ in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol, with for example relapse 9% with ATIR versus 29% for Baltimore, chronic Graft Versus Host Disease (GVHD) 4% with ATIR versus 24%, and GVHD and Relapse Free Survival 57% with ATIR versus 31%.
Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the EU as an adjunctive treatment in HSCT for malignant disease. Kiadis Pharma received Day 120 questions in September 2017 and is on track for potential (conditional) approval in H2 2018 and launch in 2019.
In September 2017 the US Food and Drug Administration (FDA) granted ATIR101™ the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
In addition, Kiadis Pharma has received regulatory approval in various countries to start dosing patients in a Phase 3 trial with ATIR101™ that will be performed across Europe and North America (195 patients, 40-50 sites, US/EU/Canada, head to head against the Baltimore protocol).
Kiadis Pharma was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the EMA.
The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels under the ticker KDS.
In this role, you will:
· Define the market access strategy, activities and timing for the EU launch of ATIR in 2019
· Select, contract and manage (a network of) market access consultants and service providers
· Be responsible for interactions and negotiations with health reimbursement agencies, payors and providers
· Write, review and approve applicable controlled documentation
The ideal candidate
Holds minimal a MSc. You have at least 12 years of experience in the pharmaceutical industry in market access, including with end responsibility for successfully completed market access projects across the EU. Preferably you have experience with cell-based ATMP’s, orphan drugs and/or oncology. To be successful, you are a strategic thought leader and innovator on the subject. Intelligent and creative. You can work fully independently with minimal guidance. A team player who will bring result-orientedness, integrity, drive, tenacity and communication and collaboration skills.
A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.
You will be rewarded a competitive remuneration package, the opportunity for personal development and to contribute to make a huge difference for patients.
For further information, please contact Jeroen Elderhorst, HR Manager, by phone at +31 (0)20 3140 250. You can e-mail your motivation letter and resume to HR@kiadis.com.