Sr. Director - Cardiometabolic Health Clinical Design

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Organization Overview :

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives.

Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism

The Clinical Design Sr. Director is the single point of accountability for the design of the global clinical plan for a given asset or portfolio of assets and the complete trial package.

This person will be a key partner to the Asset Team. The Sr. Director will work with the Therapeutic Area Design Leader and Therapeutic Area Design Clinical Research Physician to ensure that the clinical design aligns with the asset strategy and profile and is optimized to deliver cost effective science and the best clinical development outcomes.

The role will work within the CDDA to ensure smooth transition to execution. The Sr. Director will integrate clinical design capabilities and best drug development practices with therapeutic and phase specific focus and expertise.

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.

Responsibilities : Clinical Design

Clinical Design

Collaborate with the Asset Team to develop asset strategies and profiles

Partners with the Asset Team and the CDDA to develop clinical scenarios and options that will efficiently deliver desired program / protocol outcomes while driving transparency of costs, timing, risks, etc.

Closely collaborate with execution teams to understand impact of design on speed to protocol approval and optimizing through standard approaches

Partners with the Asset Team to develop viable clinical scenarios and the clinical risk assessment and mitigation / contingency planning

Ensure consistent development and finalization of trial packages (e.g. protocol, IB, ICD, functional documents / plans) to enable smooth transition into Execution

Leads the real-time application of operational governance

Ensure feasibility via robust communications throughout the design and entry into the execution phase

Partners within CDDA on country, site, and patient allocation needs

Organizational Leadership

Support flexibility of resources across therapeutic areas while aligning to deliver on portfolio prioritization

Assesses competencies that are required as business models evolve and address implications to overall resource management and strategies

Build an organizational culture that focuses inclusion and innovation, opportunities to improve, and with an external understanding and awareness

Applies project management skills and / or tools to ensure successful development of robust scenarios and options, and delivery of the complete trial package

Shared Learning and Continuous Improvement

Focus on organizational learning to identify best practices, delivering these as systematized standard approach with ultimate goal to make program and protocol design faster and less resource intensive

Ensure drug development shared learning amongst colleagues within and outside of Clinical Design

Work closely with counterparts in other TAs to continue to evolve Lilly standards, tools, and best practices across development

Identify areas of key needs across clinical development and propose meaningful and innovative solutions to address those needs

Apply innovation and lessons learned in real time

Actively engage in and influence the external environment within the therapeutic area of focus

Work closely with the Design Capabilities teams and other applicable organizations to identify technologies and capabilities to support modeling needs

Basic Qualifications / Requiremen ts :

Bachelor degree, preferably in a scientific or health-related field

Minimum 5 years of experience in area of clinical strategy, clinical planning and / or protocol development

Additional Preferences :

Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.

Previous experience in the management of global trials and / or complex / cross-functional projects

Strong communication skills

A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.

Demonstrated ability to influence team members and extended team members

Prior project management experience and / or experience leading multi-disciplinary teams

Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations

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