EndereçoDESCRIÇÃO DA VAGA
JCR Pharmaceuticals Co., Ltd. is a global Japanese multinational specializing in pharmaceuticals that is redefining expectations and expanding possibilities for people with rare and genetic diseases worldwide.
It has developed and obtained approval in Japan for the drug indicated for MPS II - Mucopolysaccharidoses - better known as Hunter Syndrome. It is a rare disease resulting from the lack of an enzyme, leading to the accumulation of complex molecules in the body, hindering the patient's development from early years and can lead to death in the first decade of life.
JCR's treatment is capable of acting both in the body and in the central nervous system, relying on the technology called J-Brain Cargo®. This allows the medication to cross the blood-brain barrier and penetrate the central nervous system, as well as acting on other organs of the body through an innovative mechanism of action never seen before in current medications.
Present in Brazil since 2020, JCR do Brasil Farmacêuticos has already submitted the drug for analysis by ANVISA, as a pioneering product in overcoming the blood-brain barrier to treat the neurological degeneration that occurs in 70% of patients with MPS type II, as well as having efficacy for treating the somatic part of the disease.
They are currently looking for a Clinical Operations Manager, who will be accountable for managing and/or supporting the clinical operation activities for clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.
RESPONSABILIDADES E ATRIBUIÇÕES
- Lead, manage and/or support and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP.
- Oversees the quality of the Clinical Operations for the studies he/she is in charge of.
- Ensure that study is Inspection ready through the study lifecycle and partake in CAPAs when needed.
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables.
- Collaborates with Clinical Science, data management and statisticians ensuring data base maintenance, interim and final database locks.
- Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies), lab supplies, lab tracking of samples.
- Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
- Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
- Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
- Collaborating closely with data management for the study activities.
- Ensures accurate maintenance and archiving of study records.
- Oversees TMF Management and/or support of study budget and timelines.
- Management of vendors, including a CRO, to the required standards.
REQUISITOS E QUALIFICAÇÕES
- Complete BsC in life sciences.
- Msc/PhD in life sciences is a plus.
- Fluent in English and Advanced in Spanish (mandatory).
- Minimum of 5 years’ experience in clinical Operations management within biotech or pharma setting.
- Experience & knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH, Inspection readiness
- Experience working in an orphan disease field is a plus
- Strong communication and interpersonal skills, with the ability to collaborate effectively across diverse functional areas.
INFORMAÇÕES ADICIONAIS
- Hybrid position, 1x/week on site at the office.
- Must have availability for eventual travel.
