Associate Director

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 Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house 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.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all.

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

The Associate Director, Clinical Trial Foundations (CTF), will serve as the subject matter expert for clinical systems supporting clinical development. In this role, you will define and execute implementation plans to deliver on the system strategies, integrations and improvements. The Associate Director is responsible for collaborating with business partners to enable development, implementation and support of streamlined, clear and compliant systems to support clinical development. This role will also work closely with external parties including vendors, industry authorities and related organizations to optimize Lilly’s capabilities to support business and customer-focused, efficient clinical development. This role will specifically be focused on the Patient Engagement space, and a further program of work relating to Digital Schedule of Activities, but not limited to these and may involve further projects and programs.

Primary Responsibilities:

Clinical Information Systems Expertise

- Understand business strategies, processes and technology as it relates to clinical development.

- Serve as domain expert to ensure data, process and/or technology interfaces are optimized across other clinical information systems that are integrated with these systems.

- Support internal audits and external inspections.

- Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays.

Project Management

- Maintain a deep understanding of assigned area processes, workflows, responsibilities, and integration points across the end-to-end clinical development process.

- Drive the application and integration of key program management processes and tools to deliver results in assigned area, ensuring the scope is achieved while managing the tradeoffs between budget, time and quality effectively.

- Lead and successfully deliver large-scale, highly complex portfolios, programs or projects.

- Partner and communicate effectively across CTF, the CDDA, and other functional areas to support regular operations and process improvement.

- Be a leader of complex conversations with the ability to influence others to adapt a differing point of view or understand a new concept or way of working.

- Build key relationships with internal and external stakeholders, such as regulators or customers, on specific business issues.

- Independently create and manage operations and project plans as needed for assigned areas; ensure realistic timelines for deliverables.

- Ensure a change control process is in place to gain alignment with peers and leaders in managing modifications to plan timelines, deliverables, milestones, resourcing needs.

- Lead OCM activities for systems including communications to end users.

- Develop and implement communication plans and drive communication of key decisions to stakeholders up-ward and cross-functionally.

- Manage governance and documentation needs for assigned area.

- Ensure quality and operational excellence of teams, support performance of processes, and create and/or manage operational metrics.

- Anticipate and resolve key technical, operational, or business risks/issues.

- In partnership with team members, collect needed data, complete analyses, and provide summaries for assigned area.

- Lead the creation, integration, and maintenance of process and business documentation for assigned area, including maintenance of team collaboration sites.

Partnership

- Partner with process owners, leadership, Quality and Information Technology to ensure capable, integrated and efficient system usage across the portfolio.

- Actively participate in shared learning across the team.

- Work with vendors to improve customer experience and efficiencies.

Minimum Requirements:

- Bachelor’s degree preferably in science, IT or health related field, or equivalent work experience preferred.

- 5 – 8 years experience with at least 3 years in medical, clinical data management, clinical drug development, or clinical information flow.

- A minimum of 10 years’ experience, with a minimum of 5 years in a project/program management preferred, ideally in a drug development or pharmaceutical setting.

- Experience of a global system rollout, including implementation, migration, testing, OCM etc.

- Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership.

- Strong problem-solving skills; able to anticipate and recognise problems, diagnose root causes and take corrective action to prevent recurrence within the team.

- Excellent self-management and organisational skills; able to manage workload, set personal priorities and adjust as needed.

- Strong interpersonal skills.

- Flexibility to adjust quickly and effectively to frequent change and altered priorities.

Additional Preferences:

- Experience in clinical development systems as well as current and evolving technologies to support clinical development and clinical data management.

- Knowledge and/or experience in project management and organizational change with Lilly staff and external parties including vendors, industry experts and related organizations.

- Good interpersonal and leadership skills.

- Excellent oral and written communication skills.

- Strong business insight.

- Demonstrated strength in logical thought, problem solving ability and critical thinking.

- Ability to communicate and influence across functional boundaries.

- Ability and experience in positively handling and resolving conflict.

- Flexibility in approach; able to adjust to unexpected business opportunities while also being a catalyst for change.

- Knowledge of regulatory and quality requirements governing clinical development.

- 10% or less travel.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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