Lava Therapeutics (LAVA) is a clinical stage immuno-oncology company that generates and develops next-generation γδ T cell engaging bispecific antibodies for the treatment of cancer. LAVA started its operations in 2016 and is advancing its proprietary platform and pipeline of bispecific therapeutic antibodies, building on cutting-edge research originating from the VU University Medical Center / Cancer Center Amsterdam.
R&D Laboratories and offices are located in The Netherlands at the Science Park in Utrecht and the Agrifood Plaza building in Den Bosch. Our U.S. office is located in old city Philadelphia, Pennsylvania.
We are expanding our team and are looking for talented individuals to support LAVA’s future success. We are currently looking for a Sr. Clinical Trial Manager.
Reporting to the Director, Clinical Operations, the Sr. Clinical Trial Manager is responsible for “end-to-end” global clinical studies, managing the overall operation of clinical studies and programs including clinical trial management, study timelines, budget, and external vendors/CROs. This hybrid position will be based in Philadelphia (1-2 days per week in the office as required).
- Clinical trial execution;
- Leads and motivates the cross-functional team and clinical trial team meetings;
- Schedules, supervises, and delivers project(s) in accordance with, ICH-GCP, LAVA’s policies and SOPs;
- Ensures projects are conducted within timelines, budget, scope and quality;
- Conducts risk and issues management and applies proper issue escalation;
- Responsible for preparation, startup, coordination and closure of Clinical Trial activities and deliverables;
- Uses metrics and reporting for managing the project;
- Serves as the primary project contact for communication and coordination for LAVA, third-party vendor(s) and project needs;
- Informs and manages stakeholders with the appropriate Clinical Trial information;
- Manages and Drives processes for outsourcing to CROs, and other third-party vendors (s);
- Interacts frequently with external partners, including expert panels, physicians and investigators, CROs, contract laboratories, advisory committees and clinical trial consultants;
- Contributes to the development of study protocols and eCRFs;
- Ensures the development of clinical trial-related documents, e.g. patient informed consent forms (ICFs), case report forms (CRFs);
- Conducts Study feasibility and ensures proper site selection and setup;
- Ensures that the TMF and ISFs are completed and meet regulatory standards;
- Arranges for the proper archiving of the clinical trial documents.
- BSc in a relevant field;
- Minimum of 4-8 years of experience in clinical operations;
- Prior oncology therapy experience;
- Experience in complex clinical research projects and early drug development is very desirable;
- Prior experience in the financial and/or Budget and Forecasting management of clinical trials is preferred;
- Understanding of early phase trials and dose escalation;
- Ability to manage multiple clinical studies simultaneously;
- Knowledge of clinical project management;
- Ability to work independently and within a group with minimal supervision.
LAVA offers a full-time position working with a highly motivated team, where high performance is recognized and rewarded. We offer the opportunity to work with a group of highly experienced leaders and professionals with a proven track record of success in the Life Science industry.
LAVA offers excellent salaries and benefits in accordance with the biotech/pharmaceutical industry. We offer flexible working hours, growth and development opportunities and a professional working environment, where hard work is balanced with fun.
This position requires up to 20% travel including to our facilities in The Netherlands.
Our Core Values
Our company culture is built on five important Core Values: Innovation, Teamwork, Results-oriented, Flexibility and Fun. We understand that innovation is at the heart of what we do. We drive the ability to innovate and we all have a strong awareness of emerging scientific and business opportunities. We work closely as a team, have a constructive and collaborative mindset and put the common interest of the company above our own individual interest. We have a strong orientation on results, we meet agreed goals in a timely and efficient manner and we deliver on our promises. We are flexible, adapt well to changing circumstances and work well under pressure. Finally, we all contribute to a safe, professional and enjoyable workplace in which people are treated respectfully and diversity is embraced.
How to Apply
Please send your CV together with a cover letter to firstname.lastname@example.org with “Sr. Clinical Trial Manager” in the subject line.
All applications and related information will remain strictly confidential.
LAVA is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
No agencies, please.