Study Responsible Physician

Job description

Member of Clinical Trial Team

Pre-trial activities :
· Contribute to the design of the trial through creation of the Trial Information Form (TIF).
· 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
· 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 Safety Monitoring Board (DSMB) protocol.
· Review and approve protocol specific PV criteria list
· Develop & agree on the Safety Management Plan (frequency, format and content of reports provided)
· Input in SOW for central lab, central ECG and other vendors as applicable
· Review of (e)CRF and other data collection tools
· Give input in site selection
· Provide trial/compound specific training to monitors

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 Data and Safety Monitoring Board (DSMB) reports as applicable.
· Perform medical review and safety analysis of clinical trial subjects; including periodic completion of the Safety Management Plan for individual trials.
· 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 Violations
· Contribute to Trial Team Meeting 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 PV listings
· Assist in preparation of the safety part of Top Line Results presentation
· Review narratives
· Assist in creation and review of Clinical Research 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

Report regularly and work closely with Global Medical Leader
Interact with clinicians/experts (e.g. Advisory boards) as necessary
Act as a support to and resource for Medical Affairs.
Assist in the creation of regulatory/submission documents (e.g. clinical summaries, clinical overviews, ASR, IND update)
Assist in creation of Investigator Brochure.
Assist in writing/review of abstracts/manuscripts.
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.
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

Education and experience
·  University degree - medical;
·  Preferably experience in drug development (e.g. Project Management, Pharmacovigilance, Medical Affairs, Pharmacokinetics), and/or
·  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 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.