Associate Director, Clinical Delivery Capabilities - EMP

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.

Eli Lilly Cork, is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies and on-site parking.  Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself.

Purpose:

The purpose of the Associate Director role is to provide operational leadership to support exploratory and biopharmaceutics clinical development. The role works across the organization including with functional and organizational partner groups to deliver knowledge, expertise, standard templates, and technology to identify various clinical development scenarios and provide functional expertise to ensure successes of portfolio delivery.

This role continually provides expertise in process and methodologies of EMP whilst looking for advancements and improvements. Key areas of responsibility of the role include: a) leading activities supporting study development and execution, b) cross-functional systems and processes, and c) systems, metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the Associate Director possesses the business acumen, process knowledge, and influence required to lead in process and quality improvement efforts.

The Associate Director will seek knowledge from internal and external sources and use this information to drive strategic discussions with clinical and functional counterparts make recommendations to gain efficiencies and speed to shape development plans and continuous improvement opportunities.

Primary Responsibilities:

1. Study Development and Execution Support:

• Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies. The team will support study development by owning updates to corporate systems and processes e.g. CT Registry, Vault Clinical, trial and compound level documentation management e.g. eTMF and the contracting elements for a study.

• Provide leadership in business interactions with TPO partners; helping to execute the exploratory and biopharmaceutics clinical development portfolio. Lead and partner in the issue escalation and relationship management processes, vendor and clinical research unit assessments as appropriate.

• Maintain awareness of regulatory issues and trends relevant to assigned portfolio.

2. Cross-Functional Systems and Processes:

• Provide leadership in business processes supporting early phase development.

• Established expertise on key business systems that support exploratory and biopharmaceutics clinical development.

• Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized. Contribute to the overall strategic direction of cross-functional systems and process.

• Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when necessary, sponsor improvement initiatives to increase business efficiency and