Sr. Advisor - Pk/Pd & Pharmacometrics

3-5 years

Not Disclosed

Indianapolis

10 Jan. 31, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Advisor - PK/PD & Pharmacometrics
Location: Indianapolis, Indiana, United States of America
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-79304

About Eli Lilly:

At Eli Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, Lilly is a global healthcare leader. Our employees work relentlessly to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism. We’re looking for people who are passionate about making a difference and committed to the pursuit of scientific innovation.

Position Summary:

Eli Lilly’s Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics (PK/PD & Pharmacometrics) Department is seeking a Sr. Advisor - PK/PD & Pharmacometrics to join our dynamic team. This position will play a pivotal role in driving the application of PK/PD and clinical pharmacology scientific expertise across drug discovery, clinical development, approval, and lifecycle management. As part of this team, you will help identify the right dose for the right drug, for the right patient, using a model-informed drug discovery and development (MIDD) paradigm.

We are looking for quantitative, collaborative, and passionate scientists who thrive on innovation and problem-solving. In this role, you will work with a variety of teams to influence key decisions and shape strategies for drug development.

Responsibilities:

Scientific Leadership: Lead and provide PK/PD scientific expertise to project teams, contributing to decisions on dose selection, patient population, and development strategies.
Data Analysis & Interpretation: Lead the design and execution of Phase I, II, and III study protocols, analysis plans, and data interpretation, ensuring clear scientific communication.
Regulatory Submissions: Prepare and support regulatory documents such as INDs, IBs, and CTDs, ensuring compliance for development and registration of new drugs.
Model-Based Decision Making: Utilize PK/PD and pharmacometric approaches to support the translation from preclinical to clinical settings, integrating relevant scientific data for decision making.
Mentorship: Coach and mentor other scientists within the department and across teams, contributing to the professional development of colleagues.
External Collaboration & Visibility: Represent the department externally by publishing in key scientific journals and participating in industry trade groups, scientific organizations, and consortia.
Scientific Advocacy: Communicate quantitative data and advocate for model-based decision-making within project teams and to external partners.

Basic Qualifications:

Education: PhD and/or MD in Pharmacokinetics/Pharmacodynamics, Clinical Pharmacology, Pharmacometrics, Computational Sciences, Engineering, Statistics, or a related field.
Experience:
- At least 3 years of relevant work experience in PK/PD, Clinical Pharmacology, or Pharmacometrics.
- Proven experience applying pharmacokinetics, pharmacodynamics, and pharmacometrics principles within drug development teams.

Additional Skills/Preferences:

Strong Communication: Ability to effectively communicate complex scientific concepts with confidence to both technical and non-technical stakeholders.
Scientific Expertise: Deep understanding and experience in applying PK/PD, clinical pharmacology, and pharmacometric approaches in drug development.
Leadership & Mentorship: Demonstrated ability to lead and mentor scientists, fostering collaboration and knowledge sharing.
Teamwork: Ability to work collaboratively across teams, disciplines, and functions, contributing to overall project success.

Other Information:

Compensation: The anticipated salary range for this role is $142,500 to $228,800, depending on qualifications and experience.
Benefits: Full-time employees are eligible for a company bonus, comprehensive healthcare benefits, 401(k) plan, vacation benefits, life insurance, and more.

Equal Opportunity Employer:

Eli Lilly is an Equal Opportunity Employer. We do not discriminate based on age, race, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status. We are committed to providing reasonable accommodations for individuals with disabilities during the application process.

If you are passionate about shaping the future of drug development and want to make a meaningful impact, apply today to join Team Lilly in Indianapolis!

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Sr. Advisor - Pk/Pd & Pharmacometrics

Job Description

About Eli Lilly:

Position Summary:

Responsibilities:

Basic Qualifications:

Additional Skills/Preferences:

Other Information:

Equal Opportunity Employer:

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