Associate Director - Clinical Design Trial Lead

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' well-being 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. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

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

Purpose:
Clinical Design provides clinical program and trial design leadership and expertise within Eli Lilly - designing novel clinical programs to answer scientific questions, align with the corporate and asset strategies, and enable delivery. The value proposition is achieved by applying design excellence competencies and principles related to value-based research, data-driven decisions, and accelerated delivery. Clinical Design leverages internal and external information within and across therapeutic areas to provide modern, innovative solutions to Lilly's drug development needs.
The Associate Director Clinical Design Trial Lead role leads a cross-functional team in the development of a high-quality design for a specified asset(s), including different design scenarios, in partnership with the Asset team. This includes providing to the Asset team transparent costs, timelines, and risks associated with the plan. In addition, the Clinical Design Trial Lead is responsible for working with Clinical Capabilities and Clinical Development to enable accelerated delivery.

Current openings in these therapeutic areas:

Cardiometabolic Health

Neuroscience

Immunology

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Plan and Trial Options and Clinical Trial Protocols

• Lead Clinical Design team in translating therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.
• Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s).
• Provides insight into impact of study/protocol design features to feasibility, value, patient and investigator burden, and execution speed/efficiency.
• Engages other functions as determined by the asset need (e. g. Safety Committees, Regulatory, Tox/PK/ADME, TTx, Bioethics)
• Utilizes external benchmark data in conjunction with the Clinical Design Capabilities in the development of clinical plans and clinical trial designs.

Clinical Research/Trial Packages, Execution and Support

• Understand how design elements influence the ability to deliver on new regulatory expectations and clinical capabilities.
• Lead the creation of risk profiles to ensure trial design has appropriate risk mitigation to enable robust data delivery.
• Collaborates with Clinical Development Sr. Director ensuring design options take into consideration the ability to enable accelerated delivery.
• Ensure consistent development and finalization of documents that support the complete trial package to enable smooth transition into delivery.

Shared Learning and continuous improvement

• Focus on organizational learning to proactively identify, apply, and share best practices and learnings related to program and protocol design.
• Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup.
• Work closely with counterparts in Clinical Design and therapeutic areas to generate ideas and continue to evolve Lilly standards, tools, and best practices that span drug development.

People Development

• Provide coaching within the organization that fosters inclusion and innovation.
• Model the Lilly leadership behaviors.
• Apply innovation and lessons learned in real time.

Minimum Qualification Requirements:

• Bachelor degree, preferably in a scientific or health-related field.
• Minimum 5 years of directly related clinical trial or pharmaceutical project management experience.
• Demonstrated knowledge and experience with project management tools and processes.
• Pharmaceutical Industry experience, or similar, that provides adequate background relevant to clinical trial design of Phase II to IV studies.
• Strong communication skills across diverse platforms and stakeholders.

Other Information/Additional Preferences:

• Post-graduate degree (e. g. Pharm D, M. S. , or Ph. D. ).
• A strong understanding of the clinical drug development processes.
• Experience working at and/or with clinical research sites.
• Previous experience in the management of global trials.
• Ability to anticipate and resolves key technical, operational, or business problems.

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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