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 also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Responsibilities :
The Clinical Development Organization, a division of Lilly Research Laboratories, partners with colleagues in Research, Oncology, Immunology, Neuroscience and Cardio Metabolic Health 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, we focus on patients, participants, and regulators to deliver novel designs and innovative research approaches. We 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.
Ensuring the effective and efficient delivery of asset clinical development programs that meet the goals and objectives of the asset strategy and profiles are critical. To make this process successful, we are seeking a Clinical Development Program Lead (CDPL). In this role, you will act as a single point of accountability for cross-functional clinical development of assets and/or programs. If you are experienced delivering high quality clinical plans that enable efficient execution, proactively manage risk, and finding opportunities to accelerate clinical development, we have the role for you.
As a CDPL in the Clinical Development Organization, we will rely on your expertise to ensure support of key clinical deliverables in support of submission, inspections and publication. You will effectively mentor, develop, individuals within the Clinical Development org and more broadly.
This role is an exciting opportunity to collaborate with asset teams to build bold asset profiles and partner across functions to craft viable clinical scenarios. You will work to deliver complete clinical trial packages that enable rapid transition into trial execution. Ideally, you will:
Identify and support novel development approaches to accelerate asset development
Champion development of the asset strategy and translate to the clinical plan across Clinical Trial Management staff
Demonstrate strong business insight, problem solving and agility to help the team adjust to changes. Demonstrate a strong understanding of the competitive landscape for your target and/or asset to ensure external takeaways are being considered in the design. Additionally, having a current knowledge of the external landscape in execution to change directions quickly in reaction to external data.
You will maintain risk plans during trial implementation in response to new data. To successfully accomplish this task, you will promote broad collaborations. You will account for budget planning, monitoring, and control of the clinical plan/budget. You will also:
Represent clinical execution/delivery function at core team meeting ensuring efficient and streamlined processes.
Document and communicate effectively appropriate information as needed.
It is key that you nurture a culture of innovation and inclusion. You will engage in continuous improvement across areas such as clinical development, complete trial packages, and process improvement. You will actively engage in project prioritization and state of inspection readiness.
Basic Qualifications:
Bachelor’s Degree, preferably in a scientific or health-related field
Minimum of 8 years’ experience in the pharmaceutical industry and/or clinical research
Additional Skills/Preferences :
Strong preference for previous Oncology clinical research experience (Pharma, Biotech, Site Clinical Trial experience, etc.)
Prior experience in leading sophisticated/cross-functional projects, and/or clinical trials
Deep understanding of the pharmaceutical drug/device development process
Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.
A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
Ability to take and defend tough/unpopular positions
Prior project management experience and/or experience leading with multi-disciplinary team
Demonstrated ability to translate strategic knowledge and effectively influence the direction of daily operations
Travel Percentage : 10-25%
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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