The Trial Capabilities Director leads the clinical trial capabilities in support of clinical development. The Director is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. This includes submission of documents to regulatory authorities and Ethics Review Boards (ERB), serve as the point of contact for a site’s ERB and Competent Authority (CA) (where applicable), assist in budget and contract negotiation. The director is accountable for the prioritisation, planning and implementation of site initiation activities working closely with the site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritisation and timely execution to meet portfolio needs.
We are excited now to add another capability to the existing GBS team. The Clinical Trial Capabilities Team will focus on clinical research and, in particular, clinical study start-up activities across the EU and other regions, e.g. Middle East, Africa and Russia. The Clinical Trial Capabilities Centre will allow us to provide an unparalleled clinical trial experience for investigators and patients and ultimately achieve Lilly’s goal of speeding innovation and bringing our medicines to patients who need them.
If you want to contribute to this goal for our patients please apply to one of our new roles today. All current open positions are permanent roles.
Basic Qualifications
Requirements:
Bachelor’s degree preferably in a scientific or health related field
Minimum of 5-7 years of experience in the pharmaceutical industry and/or clinical research experience
Prior supervisory experience
Experience in, and/or leading different groups in drug development
Knowledgeable of clinical development compliance reporting requirements
Broad understanding of pharmaceutical drug development process and clinical research Prior experience supervising an organization
Prior experience managing/negotiating clinical trial budgets/contracts
Flexibility to adjust quickly and effectively to changing business priorities and needs while dealing with ambiguity
International or regional clinical development experience
Proven ability to influence cross functionally without direct authority
Proven ability to develop diverse organizational talent
Ability to represent positions on difficult business issues
Additional Information
The GBS focuses on the following foundational pillars across the full organisation to ensure a solid and consistent approach to running our business
Compliance
Demonstrate a strong compliance oriented mindset & help to build a strong compliance culture
Familiarize with & influence all applicable process documentation & training materials to ensure you operate in a fully compliant manner
People
Actively participate in the GBS senior management team to make the GBS a great place to work for all employees and influence the strategic direction of the center
Engage interpersonal, communication & relationship building skills to interact with all levels of an organization
Customer
Demonstrate excellence in all interactions with our GBS internal customers & business partners
Focus on measuring & improving our internal customer’s experience with the GBS
Continuous Improvement
Lead a culture of continuous improvement within the Clinical Development Organisation (CDO) and the broader GBS
Influence the Global process owners to champion continued process improvement
Additional Skills/Preferences
Key Objectives / Deliverables:
Clinical Trial Capabilities Leadership
Responsible for implementing the staffing strategy for trial capabilities (site activation, site contracting budgeting, payment and reporting, study training management, site maintenance and closeout, etc.) enabling global clinical trial delivery
Responsible for ensuring the utilization of technology and informatics to standardize and increase efficiency of clinical trial capabilities and resources
Support global solutions across geographic regions and in conjunction with other clinical development functions
Ensure activities are executed in a manner consistent with established guidelines, best practices and in compliance with GCP and all applicable regulations
Ensure flexibility of resources across therapeutic areas to manage changing portfolio staffing needs
Ensure inspection readiness through a complete, accurate and readily available Trial Master File (TMF) at all times.
Organizational Leadership
Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within Clinical Development
Enable a culture of continuous improvement to drive efficiency through process improvement, technology and automation, people skills, and shared learning
Engage in the external clinical development community to leverage environmental improvements and ensure external learnings are incorporated into continuous improvement efforts
People Management and Development
Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development
Effectively manage an agile organization that continuously meets the needs of a changing portfolio
Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision
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