Clinical Development Project Manager

Based in Gembloux at Créalys Science Park, Volition (https://volitionrx.com) is a multinational life-sciences company developing simple and easy tests for the accurate diagnosis of many forms of cancer. The tests are founded on the science of Nucleosomics®, detecting the presence of possible disease.

Volition’s research and development activities are currently centred in Belgium (approximately 40 staff), with additional offices in the United Kingdom, United States and Asia, while the company focuses on commercialising its diagnostic products primarily in Europe, then in the US and ultimately worldwide. Volition has just invested in a second building in Créalys Park, to set up its production activities. Its products will be distributed globally.

Volition is a world leader in circulating chromatin technology and is commencing clinical development of some of these technologies for diseases associated with NETosis. The clinical technologies include therapeutic antibody development as well as other technologies.

In the context of its expansion, Volition requires the services of a:

Clinical Development Project Manager for Novel Therapies in Sepsis, COVID-19 and other NETosis associated diseases

Role

You will be responsible for overseeing and guiding multiple clinical studies (phases I-III), for multiple products and disease areas, overseeing outsourced partners, as well as review and assessment of the work performed, compliance, risks and bottlenecks.

Specific tasks include :

• oversee and manage daily clinical operations, including management of timelines, budgets, deliverables and vendors;
• track and prepare study data utilizing clinical trial management systems, databases, spreadsheets, and other tools;
• accountable for meeting clinical trial objectives, milestones, and deliverables, as well as reporting trial progress to management;
• assists in the identification, qualification, and management of third-party vendors, to include development of Request for Proposals (RFPs), Scope of Work (SOW), and vendor specifications documents.

Profile  

• You hold a PhD degree and 5+ years of clinical research experience in Pharma or Biotech.
• You are from biotech or pharma who has previously guided these functions.
• Experience working on Oncology, Immunology or Immunotherapy trials is needed.
• The company employs CROs for most of the manufacturing and performing the clinical studies. Therefore, experience in coordinating and overseeing the work done by CROs will be key.
• Other priorities include :

• experience managing Phases I-III clinical trials, timelines and deliverables;
• experience overseeing vendors, including CROs;
• experience monitoring managing Oncology, immunotherapy of antibody based trials is required.

• You have an excellent English verbal and written communication.
• You are open to frequent travel within Europe (especially in England).

Offer

• A building/innovative environment and one who will bring the resourcefulness and initiatives to be successful.
• A Belgian company with real potential for international development.
• A friendly and dynamic work ambience.
• An open-ended contract and attractive salary package.

Your application will be processed quickly and in confidence. habeas is managing this assignment exclusively.