Study Responsible Physician

Job description

Job Description

Requisition ID: 000019NR

Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, uses heart, science & ingenuity to create transformational medicines to improve the health of humanity
is dedicated to bringing meaningful innovation to global health. [DM[1] 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.; primary point of contact medically for assigned studies
·  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
·  Contribute to Trial Team and Clinical Team Meetings on an agenda driven basis
·  Review SAEs in real-time and provide input of the assessment as needed
·  Contribute to the development and review of protocol amendments
·  Review trial specific ICF for updates based on CTP amendment, IB amendment or updated IB
Post-trial activities (or activities related to an upcoming analysis)
·  Review and approval of “AE coding” and “concomitant medication” lists.
·  Review and provide input to queries from SAE reconciliation, as needed
·  Assist in preparation of the safety part of Top Line Results presentation
·  Review narratives
·  Assist in creation and review of Clinical Study Report and approve if applicable
·  Assist in ADR review and adjudication
·  Assist in labeling process as applicable
·  Contribute to presentation of trial results as needed
2. Report regularly and work closely with Global Medical Leader
3. Interact with clinicians/experts (e.g. Advisory boards) as necessary
4. Act as a support to and resource for Medical Affairs.
5. Assist in the creation of regulatory/submission documents (e.g. clinical summaries, clinical overviews, ASR, IND update)
6. Assist in creation of Investigator Brochure.
7. Assist in writing/review of abstracts/manuscripts.
8. Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company's effort towards continuous quality improvement.
9. Participation and cooperation in Clinical Team and in other Cross-functional teams, ad hoc.

Required Certifications/Regular Training (e.g. IATA, GCP, CAP/CLIA, IAP)
·  Employee must follow the schedule for mandatory trainings required by Janssen/Johnson & Johnson for this position, within the specified time frame; including, but not limited to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and regulations, as well as other Standard Operating Procedures (SOPs)
·  It is expected that the employee will keep up-to-date with general medical topics and topics relevant to the therapeutic area

Desired profile

Qualifications

Qualifications
Education and experience
·  University degree - medical;
·  Preferably experience in vaccine development
·  Experience in the pharmaceutical /biotech industry
·  Preferably experience in clinical development (e.g. medical dept. or operations);
·  Experience in functioning in team structure
Skills
·  Good communication skills;
·  Ability to effectively work as part of a team.
·  Conflict handling skills;
·  Good knowledge of English (both written and spoken).
·  Presentation skills
·  Organizational skills
Knowledge
·  Therapeutic (ie disease-specific vaccine expertise or viral vector based vaccine expertise) domain preferred, but not required at entry
·  Working knowledge of guidelines and applicable SOPs regarding the development of new chemical entities and the conduct and medical supervision of clinical trials, preferred, but not required at entry
·  Computer literacy
The position is based in Leiden .

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
000019NR