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.
We are seeking a highly motivated scientist to join the Laboratory for Experimental Medicine (LEM). This role is a part of a multi-disciplinary group of scientists collaborating on the investigation of immunogenicity, biomarkers, and innovation research. Apply today and join our team!
Responsibilities
Lead immunogenicity and biomarker activities and other clinical diagnostics in compliance with Lilly policies, local and international regulations, laws, guidance (e.g. FDA, EMA, ICH, etc.), Good Clinical Practices (GCPs) and corporate integrity agreements, as applicable.
Lead and collaborate with clinical teams to identify, develop and implement strategies to fully characterize, minimize and monitor the impact of immunogenicity on clinical outcome (benefit and risk) for patients treated with a Lilly biologic and to provide data analysis and interpretation relevant to these strategies.
Develop, define, and deliver immunogenicity and biomarker related regulatory submission strategies and documents for Lilly assets.
Develop and implement novel biomarker strategies to inform mechanism of action, efficacy, and safety of Lilly assets.
Advise and influence project teams regarding clinically meaningful translational opportunities.
Coordinate consultative and collaborative activities with Global Patient Safety (GPS), Clinical Pharmacology/Exploratory Medicine, ADME-Toxicology-PKPD, and other functional areas.
Actively contribute to developing novel immunogenicity solutions aligned with regulatory expectations.
Provide technical oversight of third-party organizations throughout the transfer, validation and implementation of immunogenicity and biomarker assays used in clinical trials.
Contribute to governance of Lilly relationship with third-party organization including management of the vendor quality system agreement, master service agreement, periodic inspections/audits and annual governance review.
Maintain and expand an active external focus that includes interaction with relevant regulatory agencies as well as deliver scientific presentations and publications that will demonstrate deep scientific rigor around Lilly's approaches to immunogenicity
Contribute to Lilly's in-licensing efforts of new molecules and the development of strategic partnerships.
Engage in continued training and educational efforts in clinical development and demand realization related to processes requiring laboratory medicine expertise (including investigator start-up meetings, IRB, research organizations, research cooperative groups, regional business unit staff, regulatory reviews, and partnership development efforts).
Actively set and meet professional development goals and contribute to the development of others by being an active source of mentoring and feedback.
Engage in committees, initiatives and task forces as requested by management.
Model the Lilly leadership behaviors and be an ambassador of both patients and the Lilly Brand.
Minimum Requirements
PhD degree in a scientific area (e.g., immunology, biochemistry, pharmaceutical sciences) with 0-3 years of post-graduate experience.
Additional Preferences
Scientific knowledge of preclinical immunogenicity risk assessment, clinical immunogenicity strategies and regulatory requirements is desired.
Experience on clinical immunogenicity and biomarker assay development and validation and managing external vendors is a plus.
Experience as bioanalytical/immunogenicity lead or project lead for clinical programs, leading to successful regulatory interactions, submissions, and approvals, is a plus.
Experience with working in a regulated environment (e.g., GCP, GCLP, CLIA etc) is a plus.
Strong initiative and self-propelled attitude to innovation, learning, and problem-solving.
Desire to work in a highly collaborative and team-oriented environment.
Strong publication record.
Ability to present data and summarize conclusions in written and oral forms.
Ability to influence and mentor other individuals.
Strong interpersonal skills.
Proven leadership, organizational, and relationship-building skills.
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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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