Director - LEM
- Indianapolis, IN
- Permanent
- Full-time
- 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.
- Direct experience as bioanalytical/immunogenicity lead or project lead for clinical programs, leading to successful regulatory interactions, submissions, and approvals, is highly desired.
- Direct experience on clinical immunogenicity and biomarker assay development and validation and managing external vendors is highly desired.
- Scientific knowledge of preclinical immunogenicity risk assessment, clinical immunogenicity strategies and regulatory requirements is highly desired.
- Experience with working in a regulated environment (e.g., GCP, GCLP, CLIA etc).
- 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.