Clinical Trial Manager

LAVA Therapeutics searches for a new team member:

Clinical Trial Manager

Lava Therapeutics (LAVA) is a start-up company that creates and develops next generation Vγ9Vδ2 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/ 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 testing and broaden its pipeline and bispecific Vg9Vd2 T cell engager platform. In the ccoming two years, two compounds will be brought to the clinic. Expanding our team with talented, employees is key to LAVA’s future success. The company is based in Utrecht, The Netherlands.

LAVA offers an attractive set of labour conditions, recognizing and rewarding its high 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 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 grow 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 trials. We are seeking for

  • A self-motivated, energetic and detail-oriented professional with an affinity for project management
  • She/he is proficient in on time/on budget/on quality project management while adhering to regulatory guidelines (ICH/GCP)
  • She/he participates in CRO and vendor selection for the clinical trials
  • She/he will be responsible for initiation, execution and closure of clinical trials and will be working with experts responsible for PK/PD, data management, statistics, medical writing, regulatory affairs, clinical supplies, medical oversight
  • She/he is primary contact for CROs, other vendors and clinical sites for operational execution of the trials and leading the contract negotiations with these external parties
  • She/he develops the clinical trial protocol based on the approved clinical trial protocol synopsis together with clinical experts and CRO
  • She/he contributes to other study documents like PIF/IC, eCRF, monitoring plan, data management plan,
  • She/he arranges for submission and approvals by ethics committees and competent authorities together with regulatory affairs staff
  • She/he monitors and optimizes clinical supply availabilities and patient recruitment
  • She/he writes and submits all relevant trial related reports together with CRO
  • She/he represents clinical operations in the overall LAVA project team.

Qualifications

  • MSc in (bio-)medical, biological, biotechnology sciences or equivalent by experience
  • Auto-immune and/or oncology clinical trial experience
  • Industry experience: 5-15 years’ experience in clinical operations and managing CRO’s 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

  • A full time position
  • A permanent position after one year of temporary contract and a positive appraisal
  • Salary and benefits according to biotech industry standards
  • A set of excellent labor conditions

How to apply

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

Your application and related information will remain strictly confidential.