Clinical Development Manager, ViiV

Your Responsibilities:
Clinical Investigation Lead (CIL) on cabotegravir clinical development team. The role operates within a matrix environment involving team members across the world. Cabotegravir is an HIV integrase inhibitor in global phase 3 development as a long-acting injectable agent for both HIV prevention and treatment.

JOB PURPOSE & KEY REPSONSIBILITIES

To have a single point of accountability for delivery study results that provide data to adequately address questions concerning efficacy, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are properly adhered to through:
• Leadership of the study teams in the design, development and delivery of high quality, timely studies ('end to end' from Commit to Study to reporting and publication which includes working with Region/LOC (Local Operating Company)
• Accountability for medical governance and regulatory reporting at the study level (through the physician CIL or a physician on the team) by providing leadership at study level to ensure accuracy, quality and timeliness of update of operational data maintained in systems used to track studies

JOB RESPONSIBILITIES

1. Leads the Study Team(s) in order to deliver high quality, timely studies
-Determine appropriate resources required throughout the study lifecycle
-Clearly delineates study objectives, required internal/external resource, budget, timelines and collaborates with Study team members and Medicine Development Center (MDC) & Center for Clinical Study Excellence (CCSE) where appropriate
-Ensures effective management of the study plan including all activities, budget and timelines
-Ensures effective communications with Staff in the regions/countries with regards to study plans, design, implementation and analysis
-Works with team members to identify, select and oversee third parties (e.g. CROs, central labs etc.)
-Understand Risk Mitigation Plans & Strategic and the GSK Clinical Research Pandemic Response program to ensure the study team has considered the patient safety and data integrity impact of a disaster (i.e. flu pandemic)
-Appropriately interacts with Key External Experts and alliance partners when needed
-Identifies appropriate Study Steward within the team

2. Ensures the high quality of protocol documents are developed and executed with the Clinical Development Plan (CDP) to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
-Ensures timely review and approval of key study documents
-Ensures study protocol, Clinical Study Report (CSR) and other documents reflect input from internal and external experts/thought leaders

ACCOUNTABILITY

1. Ensures completion of medical governance and regulatory reporting at the start to ensure overall safety of the study subjects
-Ensures safety of study subjects through sound study design and analysis, and appropriate medical monitoring of the study
-Ensures all regulatory reporting requirements are met
-Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), audit findings etc.
-Ensures prompt, quality communications with sites regarding protocol clarification and procedural queries
-If Internal Safety Review Committee (ISRC)/IDMC data review is required, participates in, or leads identification of internal or external ISRC/IDMC members, respectively and preparation of charter (if CIL is physician). Co-ordinates with Global Safety and Pharmacovigilance (GCSP) if CIL is not a physician
-Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objectives (Physician input required if CIL is not a physician)

2.With an appropriate sense of urgency, ensures delivery of quality design, execution, analysis and interpretation of data throughout the study
-Understands and anticipates questions from internal and/or external stakeholders regarding data results
-Working with the Physician Project Lead (PPL), clearly communicates results to internal and external stakeholders and regulators
-Liaises with PPL & commercial to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursability where possible
-Ensures effective cost management during the study
-Ensures delivery of target enrolment and high quality data at regional and individual locations to reflect development interests in selected or specialty countries

Why You?

Basic qualifications:
• Basic Life Science degree or equivalent
with a minimum of 5 years of experience running clinical trial from concept study idea to publication
• Clinical training and/or applicable clinical research experience
• Matrix management experience
• Effective communications skills
• Good interpersonal relationship building/maintenance

Preferred qualifications:
..

Why GSK?:
ViiV Healthcare is a pharmaceutical company specializing in the development of therapies for HIV infection that was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. At ViiV Healthcare our scientists are 100% dedicated to finding new ways to limit the impact of HIV on the 35 million people living with the virus.

Contact information:
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