MEDICAL MONITOR

Job description

Details:
ViiV Healthcare is an independent, global specialist HIV company combining the HIV expertise of GSK, Pfizer and Shionogi, with a broad portfolio of antiretroviral medicines, an industry-leading pipeline, and several first-of-their-kind programmes to improve access to medicines and support novel on-the-ground community initiatives. ViiV Healthcare has established a presence in 16 countries and we are uniquely positioned to be at the forefront of advancing HIV treatment and care because we are the only pharmaceutical company 100% focused on HIV.

Through our focus on patient-centred innovation we have developed a strong portfolio of medicines that are advancing treatment and care for people living with HIV around the world. Our broad product portfolio includes a range of therapeutic options throughout the treatment spectrum. The primary focus is on the growth portfolio namely dolutegravir and cabotegravir based regimens as well as the newly acquired (Ex-BMS) assets, which includes asset combinations from phase IIb through to in-market such as Tivicay, Triumeq as well as DORI, D3, CAB/RPV, CAB prevention, fostemsavir, Maturation Inhibitors and other novel agents early in development pipeline

Job Purpose and Key Responsibilities:

• Contribute to study protocol development and provides technical approval of final protocol.
• Review and approve for the core subject Informed Consent Form (ICF).
• Contribute to the development of the annex documents, including but not limited to study procedures manual (SPM), reporting and analysis pal (RAP), protocol deviation management plan (PDMP)
• Contribute to the development of responses to regulatory authorities queries
• Support the Clinical Investigation Lead (CIL) in the preparation of answers to local Institute Review Board (IRB)/Ethic Review Committee (ERC) questions
• Address medical issues and concerns that arise during the study feasibility assessment
• Provide medical perspective on overall study conduct, procedures and management of safety events to with clinical study team
• Liaise, within 24 hours of receiving serious adverse event (SAE)/death notification/alert, with the site and/or investigator to obtain all necessary documentation to assist the Safety Review Team (SRT) and/or safety physician/scientist with establishment of causality/expectedness of SAE/death
• Liaise with the study laboratory regarding laboratory abnormalities of interest
• Report SAE/death and laboratory abnormalities to central study team , safety physician/scientist, the safety review team, Project Physician Lead (PPL) and the ViiV Safety and Labelling Committee (VSLC)
• Contribute to the SAE case narratives
• Contribute to the safety/clinical sections of the Clinical Study Report (CSR)

Accountability:
• Evaluation of safety event reports, including SAE, adverse events (AE) and laboratory values of concern
• Escalate safety event reports in a timely manner
• Present SAE information and evaluations to the relevant safety oversight boards such as but not limited to SRT and VSLC
• Communicate output of safety oversight board to sites and/or CRO, if applicable. i.e. restart after liver-stopping criteria
• Provide guidance regarding protocol-related medical issues to sites and/or CRO in a timely manner
• Provide review and approval of study protocol and ICF
• Ensure electronic protocol inquiry platform (ePIP) files inclusive of safety events and other study-related matters are filed in the study Trial Master File (TMF) or electronic TMF (eTMF)
• Provide training in subject protocol-defined safety parameters and toxicity management

Please apply via the online application system.

Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

Applications closing date 1st September 2017

*LI-VIIV
*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
• Physician ( MD or equivalent), with clinical fellowship in Infectious Diseases and/or experience in clinical development and/or clinical trials execution in Infectious Diseases
• Significant drug development or clinical trials experience
• Understanding of running clinical trial from concept study idea to publication

Preferred qualifications:
• Expertise in HIV drug development
• Excellent leadership experience in a matrix environment
• Effective communication skills
• Good interpersonal relationship building/maintenance