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Tubulis GmbH · 1 day ago

Clinical Scientist (Manager/Senior Manager)

Greater Boston

Full-time

Hybrid

Mid, Senior Level

1+ years exp

Tubulis GmbH is a fast-growing biotech company focused on developing novel therapies for cancer treatment. As a Clinical Scientist, you will support the planning and execution of global clinical trials for antibody-drug conjugates, working collaboratively with cross-functional teams to ensure timely and high-quality clinical study management.

BiotechnologyHealth CareLife SciencePharmaceuticalTherapeutics

Hiring Manager

Jennifer Metivier, MS

Responsibilities

Support the Medical Director in the oversight of clinical studies including review and interpretation of clinical trial data and timely execution of deliverables in collaboration with relevant internal and external partners

Take a lead role in writing protocol amendments, informed consents, and other protocol-related documents for the operational execution of clinical studies

Participate in the start-up of global clinical studies, working with Clinical Operations to ensure on schedule site activation and subject enrollment, monitoring, compliance with safety practices, policies, procedures as well as the day-to-day management of a clinical trial

Implement clinical study parameters, deliverables, policy compliance and resource needs

Actively identify areas of emerging risk for the execution of clinical studies and proposing solutions to minimize and mitigate risk. These may include meeting timelines in site activation, enrollment, identifying shortcomings or delays in data entry at clinical sites, and ensuring the timely execution of responses to regulatory interactions

Play a key role in the review of study data to ensure timely and high-quality data entry, including review of case report forms, assists in coding, analysis, and proper and complete documentation of clinical data

Participate in investigator meetings, investigator engagement, including assisting in the preparation of Advisory Board meetings

Support the Medical Director in managing sites to ensure study treatment discontinuation or other safety decisions are made per protocol and align with stakeholders within the study team

Support the Medical Director to coordinate relevant and timely data analyses and presentations in collaboration with safety, data management, Data Monitoring Committee, Biostatistics, Pharmacometrics and Biomarker teams to meet timelines for safety monitoring committee meetings, regulatory documents and to internal reviews to make timely program decisions regarding study objectives

Participate in the training of site and company staff on the study protocol, ensure the clinical staff have the necessary guidance

Qualification

Clinical development in OncologyClinical trial data analysisProtocol developmentClinical practice (GCP)Data integrityMicrosoft ExcelPresentationWritten communicationOral communicationPresentation skillsTeam playerSelf-motivated

Required

A minimum of 1 year of experience as a clinical scientist supporting interventional studies in oncology (biotech/pharma/CRO) is required

BS or BSN is minimally required

Strong knowledge in clinical development in Oncology development is required

Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring

Understanding of good clinical practice (GCP) for execution and evaluation of clinical trials

Significant experience with data integrity, exploration, analysis and presentation

High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to early disease clinical research and the highest personal and ethical standards

Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates

Requires capabilities to work on additional studies moving into operation in later years

Hold a strong understanding how these various functions work, the Clinical Scientist should be capable of implementing translational medicine approaches for clinical development

Proactive team player, results-oriented, and striving to find best solutions in a collegial team environment

Self-organized, self-motivated, and able to work independently

Excellent written communication, oral communication, and presentation skills are required