Clinical Operations Manager

LAVA Therapeutics searches a new team member:

Clinical Operations Manager

Lava Therapeutics (LAVA) is a start-up company that creates and develops next generation γδ T cell engaging bispecific antibodies for the curative treatment of cancer.

LAVA started its operations in 2017 and is advancing its proprietary platform and pipeline of bispecific therapeutic antibodies, building on cutting-edge research originating from Dr. Hans van der Vliet’s group at the VU University Medical Center and Cancer Center Amsterdam. In 2018, LAVA raised EUR 16 million in its first major institutional financing round that will allow LAVA to develop a lead candidate for clinical testing and broaden its pipeline and bispecific γδ T cell engager platform. In the coming two years, two compounds will be brought to the clinic. Expanding our team with new, talented, employees is key to LAVA’s future success. The company is based in Utrecht in The Netherlands.

LAVA offers an attractive set of labor conditions, recognizing and rewarding its highly talented and motivated employees. This includes the ability to work together with a group of highly experienced leaders and professionals who all have a track-record of success in their field of business and in Life Science industry, we offer flexible working hours, a premium-free pension plan, 30 paid vacation days, opportunities for growth and development and a professional working environment in which hard working is balanced with fun.

The position

  • We are searching for candidates with a proven knowledge of all aspects of clinical operations, preferably in oncology or auto-immune/anti-inflammatory studies. We are seeking a self-motivated, energetic and detail-oriented professional with evident affinity for project management of vendors and CROs
  • He/she will be responsible for initiating, execution and closure of clinical studies and will be working with experts responsible for PK/PD, medical writing, data management, statistics, regulatory affairs, clinical supplies, medical oversight, etc.
  • He/she develops the study protocol based on approved study outline together with CRO and clinical experts
  • Contributes to other study documents e.g. eCRF, IC, monitoring plan, data management plan, etc
  • Arranges for submission and approvals by ECs and competent authorities together with regulatory affairs staff
  • Primary contact for CROs, other vendors and clinical sites for operational execution of the plan and leading the contract negotiations with these external parties
  • Monitor and optimize clinical supplies availabilities and patient recruitment plans
  • On time/on budget project management while adhering to regulatory guidelines (ICH/GCP)
  • Writes and submits adverse event safety monitoring reports and clinical study report together with CRO
  • Clinical operations representative in overall project team

Qualifications

  • MSc in (bio-)medical, biological, biotechnology sciences or equivalent by experience
  • Auto-immune and/or oncology clinical study experience is a plus
  • Industry experience: ~5-15 years in clinical operations and managing CROs and vendors
  • Demonstrated ability to collaborate with a diverse group of scientific professionals by maintaining good internal and external working relationships
  • Must be able to work on multiple simultaneous tasks with limited supervision

Offer

  • Full time position, flexibility in the initial year regarding number of days
  • Permanent position after one year temporary contract and a positive appraisal
  • Salary and benefits according to biotech industry standards

How to apply

Please send your CV together with a cover letter to info@lavatherapeutics.com referring to the Clinical Operations Manager vacancy.

Your application and related information will remain strictly confidential.