Study Responsible Scientist

Job description

Job Description

Requisition ID: 8106190221

Janssen Vaccines & Prevention B.V., previously Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.

In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.

For upcoming positions, we are recruiting for a Trial Physician (m/f)

General description of tasks/activities

1. Member of Clinical Trial Team

Pre-trial activities:
·  Contribute to the design of the trial through creation of the Protocol Elements Document (PED)
·  Contribute to the development of the Clinical Trial Protocol and its review within the specified timelines.
·  Contribute to the development and review of the trial specific risk benefit document, as applicable
·  Contribute to investigator meeting presentations/site initiation visits (SIV) as applicable
·  Contribute to the development and review of the compound specific risk language for Master Informed Consent Form
·  Review the Trial specific Master Informed Consent Form within the specified timelines.
·  Contribute to responses to trial related questions from IECs/IRBs
·  Review the Statistical Analysis plan (SAP) within the specified timelines.
·  Review the Data Monitoring Committee (DMC) or Data Review Committee (DRC) charters, as applicable.
·  Review and approve Safety Monitoring Plan and SAE Reconciliation Guidelines
·  Develop & obtain approval of the Medical Review Plan (agree on the frequency, format and content of the data provided to the Medical Reviewer)
·  Contribute to insourcing/outsourcing decision and selection of CRO (if applicable)
·  Input in SOW for CRO, central lab, central ECG and other vendors as applicable
·  Review of (e)CRF and other data collection tools
·  Review and approve major & minor protocol deviation (PD) criteria
·  Review and approve Site IP Procedures Manual if applicable
·  Give input in site selection
·  Provide trial/compound specific training to monitors and vendors, as applicable
During trial activities:
·  Answer trial related medical questions and interact with investigators/sites, CROs, etc.
·  Review medical aspects of screening and ascertain suitability of subjects as needed
·  Review of the Data Monitoring Committee (DMC) or Data Review Committee (DRC) reports as applicable.
·  Lead Protocol Safety Review Team if applicable
·  Conduct medical review as per trial-specific Medical Review Plan including completion of the Medical Review Form (FRM‐10977) to document the medical review outcome.
·  Interacting with Safety Management Team (SMT) assist in the determination whether new safety information requires an Amendment to the CTP and/or ICF
·  Review and approval of “AE coding” and “concomitant medication” lists.
·  Review AEs of Special Interest
·  Assess Protocol Deviations

Desired profile

Qualifications

·  An advance degree is required.
·  Experience in vaccine development is required.
·  Experience in the pharmaceutical /biotech industry in required.
·  Preferably experience in drug development (e.g. Project Management, Pharmacovigilance, Medical Affairs, Pharmacokinetics)
·  Preferably experience in clinical development (e.g. medical dept. or operations);
·  Experience in functioning in team structure.
Primary Location
United States-Maryland-Rockville-
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
8106190221