Sr. Director – Clinical Design Program Lead - Neuroscience

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Director for Clinical Design to lead innovative clinical trial designs. This role involves translating therapeutic strategies into actionable clinical programs while ensuring compliance with evolving regulatory standards. You will collaborate with cross-functional teams to enhance trial efficiency and effectiveness, focusing on patient-centered approaches and risk mitigation. This is a unique opportunity to impact the drug development landscape significantly, fostering a culture of continuous improvement and innovation. If you are passionate about making a difference in healthcare and possess strong leadership skills, we invite you to apply for this transformative role.

Qualifications

• 5+ years of clinical trial or pharmaceutical project management experience.
• Strong understanding of clinical drug development processes.

Responsibilities

• Lead Clinical Design team to create high-quality clinical development programs.
• Ensure trial design meets regulatory expectations and mitigates risks.

Skills

Clinical Trial Management

Project Management

Communication Skills

Regulatory Standards Knowledge

Education

Bachelor's Degree in Scientific or Health-related Field

Post-graduate Degree (Pharm D, M.S., or Ph.D.)

Tools

Project Management Tools

Job description

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.

Purpose:

Our Clinical Design function provides clinical program and trial design leadership and expertise within Eli Lilly – crafting novel clinical programs to answer scientific questions, align with the corporate and asset strategies, and enable delivery. The team leverages internal and external information within and across therapeutic areas to provide modern, innovative solutions to Lilly’s drug development needs!

In partnership with the Asset team, the Senior Director, Clinical Design Program Lead will lead a cross-functional group in the development of a high-quality design for a specified asset(s), including different design scenarios. This includes providing costs, timelines, and risks associated with the plan. In addition, the Program Lead is responsible for working with Clinical Capabilities and Clinical Development to enable accelerated delivery. This role integrates clinical design and best drug development practice with therapeutic and phase specific focus and expertise.

Primary Responsibilities: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. Optionality will address business and customer needs (patient, prescriber, payer, and/or regulator); be in alignment with phase of product lifecycle; and clearly articulate associated tradeoffs in value (data generated, risks created/discharged, cost, and time).
• 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). Adjust optionality in accordance with feedback from leadership.
• 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 (e.g. reference trials, design analytics, country identification/allocation)

Clinical Research/Trial Packages, Execution and Support

• Understand how design elements influence the ability to deliver on new regulatory expectations (e.g. decentralization of clinical trials, increase racial and ethnic diversity in clinical trials) and clinical capabilities (e.g. value-based, patient accessibility, patient burden).
• 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 (e.g. protocol, functional documents/plans) 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 within and outside the organization.
• Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup. Identify and participate in opportunities to analyze experience and improve approaches.
• Work closely with counterparts in Clinical Design 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 cultivates inclusion and innovation, continual improvement, and an external understanding and awareness

Basic Qualifications:

• 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 experience, or similar, of at least three (3) years that provides adequate background relevant to clinical trial design of Phase II to Phase IV studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).
• Strong communication skills

Additional Skills and Preferences:

• Post-graduate degree (e.g. Pharm D, M.S., or Ph.D.)
• A strong understanding of the clinical drug development processes and the interdependencies of the various tasks/functions
• Previous experience in the management of global trials
• Experience working at and/or with clinical research sites
• Ability to drive solutions affecting results within a business area