Lilly Advisor in Indianapolis, Indiana
The Clinical Development Organization (CDO), a division of Lilly Research Laboratories (LRL), partners with Medical colleagues in Research, Oncology, Biomedicines, and Diabetes to effectively and efficiently design, plan, and execute clinical trials across all phases of research. Uniting authorities in clinical development and design, laboratory and data sciences, site engagement, and trial capabilities, the CDO focuses on participants, patients, and investigators to deliver novel designs and innovative research approaches. Our focus on excellence in bringing these capabilities together and providing diverse career opportunities within global clinical development has established Lilly as an industry leader in bringing new medicines to patients.
As the Advisor – Process Owner, you will be accountable to speed innovation by providing expertise, focused ownership and effective management of your assigned global processes, such that they are compliant, fit-for-purpose and efficient. The Advisor is responsible for the end-to-end process design, management and continuous improvement across functional lines. To achieve this, you will work closely with business partners to lead efforts to design, sustain and continuously improve the efficiency and effectiveness of processes.
Sound interesting to you? Read on to find out the key responsibilities you will have in this role.
Business Process Ownership
Leverage drug development expertise and knowledge of internal and external requirements, industry standard methodologies and benchmarks, new capabilities and advances in technology, including information flow, to influence operational strategy and design processes that meet overall clinical development performance objectives.
Establish clear understanding of assigned processes including clarity of process inputs, outputs and dependencies (e.g., connected processes, data standards, information flow implications, etc), and role accountability for critical steps and decisions.
Lead cross-functional project teams through development of process maps, process documentation (e.g.,quality system documents, TMF indexing, etc), and personnel qualification strategies.
Establish qualification requirements for those individuals within functions and teams who will execute processes.
Establish process controls (i.e., key measures for risk, quality defects, speed and cost) by which each process will be assessed.
Define and lead the continuous improvement agenda for the end-to-end process, and ensures compliance within a continually changing regulatory and industry landscape.
Communicate to governance bodies on process performance and any remediation/change efforts.
Collaborate with other Process Owners, functional leaders, business units, subject matter experts (SMEs), Quality, Compliance and Legal to define applicable compliance and business requirements to design efficient and compliant processes.
Partner with line management and SMEs to ensure process execution expectations are clear, collect process performance feedback and make sure the process runs smoothly and efficiently.
Expertise and Employee Development
All Advisors are expected to engage in coaching and training to ensure the effective implementation and execution of their processes. Some Advisors may have direct reports, depending on the scope and nature of the assigned processes. For those who have supervisory duties, the following responsibilities are applicable.
Set expectations for employees within your team with regard to process management, measurement and continuous improvement, as well as influence and partnership across functions.
Continually strengthen and improve the capability and expertise of the team to drive simplification and continuous improvement throughout Lilly’s clinical drug development systems and business processes.
Recruit and maintain an effective team with diverse backgrounds and skill sets. Ensure team member's development through experiences, the application of HR processes and support of technical knowledge development.
Effectively engage in the external environment to ensure a continuous state of awareness regarding current and evolving trends in relevant topic areas. Effectively incorporate insights into training and development and process improvement initiatives.
Project Leadership Related to Area of Process Ownership
Define and lead cross-functional projects that are within or aligned with the scope of process ownership.
Authoritatively represent assigned processes within broader change or transformation initiatives
Advanced degree (Masters, Doctorate) in a science-related field preferred
Protocol development or management
Demonstrated influence with peers, management and senior leadership
Ability to drive and lead change, collaborate across boundaries and achieve results
Solid ability to synthesize information from multiple sources and make risk-based decisions
Experience in multiple facets of drug development and/or pharma project management experience
A deep understanding of quality systems and process management
Six Sigma Black Belt or Green Belt experience
Ability to work in a rapidly changing environment and conquer complexity
Demonstrated ability to recruit and develop top talent
Effective written and presentation skills
20% or less travel
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an extraordinary work environment:
Business Week magazine 50 Best Places to Launch A Career ™
FORTUNE 50 Best Companies for Minorities ™
Working Mother 100 Best Companies for Working Mothers ™
Science magazine Best Companies for Scientists ™
DiversityInc. Top 50 Companies for Diversity™ (#16 in 2017)
Human Rights Campaign Corporate Equality Index™ – 100% score
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.
Director/Advisor - Clinical Development
Minimum of 8 years of experience in drug development (e.g. pharmaceutical or biotech company, clinical research organization, academic clinical trials)
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Are you seeking a career that makes a difference in the world? Do you have a passion for continuous improvement? Are you good at identifying opportunities to increase process efficiency and effectiveness? If so, we have the role for you.
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 39,000 global employees 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.
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