Eli Lilly and Company
Sr. Director - Cardiometabolic Health Clinical Design
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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.
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 can also 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 a 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 Collaborate with the Asset Team to develop asset strategies and profiles. Partner 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 the impact of design on speed to protocol approval and optimizing through standard approaches. Partner 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. Lead the real-time application of operational governance. Ensure feasibility via robust communications throughout the design and entry into the execution phase. Partner 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. Assess competencies that are required as business models evolve and address implications to overall resource management and strategies. Build an organizational culture that focuses on inclusion and innovation, opportunities to improve, and with an external understanding and awareness. Apply 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 approaches with the 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/Requirements: Bachelor's degree, preferably in a scientific or health-related field. Minimum 5 years of experience in the 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. 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 is an EEO/Affirmative Action Employer and 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. #WeAreLilly
#J-18808-Ljbffr
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 Collaborate with the Asset Team to develop asset strategies and profiles. Partner 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 the impact of design on speed to protocol approval and optimizing through standard approaches. Partner 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. Lead the real-time application of operational governance. Ensure feasibility via robust communications throughout the design and entry into the execution phase. Partner 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. Assess competencies that are required as business models evolve and address implications to overall resource management and strategies. Build an organizational culture that focuses on inclusion and innovation, opportunities to improve, and with an external understanding and awareness. Apply 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 approaches with the 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/Requirements: Bachelor's degree, preferably in a scientific or health-related field. Minimum 5 years of experience in the 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. 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 is an EEO/Affirmative Action Employer and 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. #WeAreLilly
#J-18808-Ljbffr