Clinical Project Manager

Vacature Clinical Project Manager

Your challenges are to successfully manage global, multi-center trials. You play an important role in the clinical trial process. You proactively plan all key events, coordinate all stakeholders and lead the team in an oncology clinical trial setting. You perform a wide variety of activities to support the start and completion of clinical research studies. You help to draft clinical trial protocols, informed consent forms and various other clinical documents. You manage multiple projects, negotiate budgets, timelines and responsibilities and monitor relevant regulations.

Bedrijfsprofiel

ISA Pharmaceuticals is a privately held company based in Leiden, the Netherlands. With a dedicated team of 25 professionals, ISA focuses on the development of immunotherapies for the treatment of cancer and persistent viral infections. ISA’s immunotherapy platform is based on its proprietary SLP® (synthetic long peptide) and AMPLIVANT® technologies. Various clinical trials up to completion of Phase 2 have demonstrated the safety, tolerability and clinical efficacy of SLP® immunotherapies. Recently, ISA has announced a strategic collaboration with Regeneron, Inc. to continue to develop our lead product ISA101 with their anti-PD1 cemiplimab targeting HPV16+ indications (cervical cancer and head & neck cancer) in two large late stage clinical trials which gives rise to new job openings.

Profiel Clinical Project Manager

You have a MSc degree in medicine, health care, life sciences or a related field with at least 5 years relevant experience in clinical research and proven CPM experience. CRA certification is preferred. You have in-depth knowledge of GCP, ICH guidelines and relevant regulations. Experience in leading cross-functional and multinational teams. You are flexible, have a can-do mentality and are able to multi-task. You possess good communication skills and computer skills and are fluent in written and spoken English. You are a self- starter.

Arbeidsvoorwaarden

We offer you a challenging position in the late stage clinical development of cutting edge therapeutic cancer vaccines and in a young and rapidly developing organization. Together with our strategic partner you will be part of an international team of top professionals in an inspiring environment. You will become part of the team that might enable one of the first synthetic , off-the-shelf, therapeutic cancer vaccines to reach registration. You will have plenty of opportunities for personal and professional growth with competitive benefits.

Contact

For further information on this job opening and related career opportunities, please contact Sonja Visscher at ecruitment@isa-pharma.com">recruitment@isa-pharma.com or +31 71 3322310. Acquisition based on this advertisement is not appreciated.

Locatie

Leiden

Opdrachtgever

ISA Pharmaceuticals BV

Publicatiedatum

04.01.2018

Publicatie eindigt

05.03.2018

ISA Pharmaceuticals BV
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