Job Description

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.

• Provide scientific leadership to project teams through the use of pharmacokinetics (PK)/pharmacodynamics (PD)/ pharmacometrics (PMx)/quantitative systems pharmacology (QSP) principles and methodologies to support the selection of the right target, molecule, dose, patient population, and overall development strategy. Support decision-making through partnership and collaboration on cross-functional teams.
• Apply PK/PD/PMx/QSP model informed drug development (MIDD) approaches to translate from preclinical to the clinical setting by integrating data from multiple disciplines. Apply and conduct appropriate modeling and simulation activities to inform drug and device development programs.
• Develop PK/PD sections of clinical development plans. Lead and support the preparation and delivery of Phase I-IV study protocols, analysis plans, data interpretation, clinical study reports, and standalone population PK/PD reports. Provide direction and scientific oversight of deliverables contracted to clinical research organizations (CROs).
• Preparation of relevant sections of investigational new drugs (INDs), investigator’s brochures (IBs), common technical documents (CTDs), clinical study reports (CSRs), and other regulatory documents for development and registration of drugs, devices, and line extensions across multiple geographies. Engage in direct interaction with global regulatory agencies.
• Provide external evaluation of scientific assets for potential in-licensing/acquisition.
• Interface with local and senior management on team progress, scientific issues/gaps, timelines, and resource needs.
• Write, revise, review, and/or serve as content expert for departmental standard operating procedures (SOPs) and processes, when appropriate.
• Continual evaluation of literature and external environment to stay up to date on the latest relevant regulatory guidance documents (e.g., NMPA, ICH, FDA, EMA), technologies, methodologies, software that has potential application to the functional area, and cross-functional development teams.
• Publish scientific articles, abstracts, and/or external technical presentations, depending upon the stage of development.
• Actively lead key scientific organizations, industry trade groups, consortia, and interaction/collaboration with academia. Provide scientific peer review.
• Provide coaching and mentoring to other scientists within the department and in other disciplines. Supervise post-doctoral scientists, academic contractors, and internship students when appropriate.
• Perform responsibilities delegated by a group leader, director, or senior director.

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 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.

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