Kiadis Pharma is a biopharmaceutical company based in Amsterdam, The Netherlands. We focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a risky procedure that is often the last hope for patients, safer and more efficient. This means we have a passionate team that is dedicated to make a huge difference for patients. If you are up to the challenge and would like to be part of our team, we are currently looking for a Project Manager Analytics.
As a Project Manager Analytics at Kiadis Pharma, you will:
- Support the Director Analytics and Validation by coordinating and tracking the progress of analytical (sub)-projects, preparing overviews and highlighting issues.
- Act as facilitator for a variety of work flows of the AD/QC department and be an important communication link to other departments of Kiadis as well as external vendors.
- Develop detailed project plans.
- Document and present project updates, decisions and stage summaries.
- Track progress of deliverables against timelines and specifications.
- Document lessons learned and suggest procedural improvements.
- Carry out risk assessments with project stakeholders.
The ideal candidate
- Holds an MSc in biologics, biomedicine or equivalent.
- Has at least 3 years of experience in a project management role in the pharmaceutical industry or biotech.
- Excellent knowledge of MS Office including MS Project.
- Is ideally PM-certified, e.g. PMP, IPMA, PRINCE2.
- Has experience with quality-related procedures.
- Has familiarity with the drug development process and associated departmental functions.
- Ideally is experienced in activities related to analytics, e.g. method transfer and/or validation.
- Ideally has experience in a GMP environment.
- Has excellent written and verbal communication 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)20 240 5250. You can e-mail your motivation letter and resume to email@example.com.
Kiadis Pharma’s allodepleted T-cell immunotherapy product candidate, given after a haploidentical hematopoietic stem cell transplantation (HSCT), is designed to reduce Graft versus Host Disease (GVHD). Single dose Phase 2 data with lead product candidate ATIR101 in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol, with reduced risk of GVHD. 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 submitted responses to the Day 120 List of Questions in March 2018 and is on track to potentially obtain a positive CHMP opinion for ATIR101 in Q4 2018 and (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101 across Europe and North America (head to head against the Baltimore protocol). The first patient was enrolled in December 2017.
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.