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Director Eli Lilly Rn Jobs (NOW HIRING)

Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is ... The Project Statistician at the Director level provides statistical leadership in multiple ...

Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is ... The Project Statistician at the Director level provides statistical leadership in multiple ...

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Senior Director, Clinical Pharmacology/Translational

Remote

Eli Lilly and Company
Pharmaceutical Product Wholesalers • 10K+ employees

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 7 days ago


Eli Lilly and Company rating

8.9

Company rating: 8.9 out of 10

Based on 64 frontline employees who took The Breakroom Quiz

9th of 86 rated pharmaceutical


Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.


Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Description of Role

Centessa is seeking an experiencedSenior Director, Clinical Pharmacologytoprovide scientific and strategic leadership for translationalclinical pharmacology across a diverse pipeline spanning early development throughlatestageand registrational programs.Reporting to the Executive Director, Clinical Pharmacology,this positionis accountable for developing and executing clinical pharmacology strategies that address the unique challenges of neuroscience drug development, including CNS exposure, dose optimization, and translational relevance. The Senior Director partners closely withcrossfunctionalteams, and cross-program teams to achieve broader translational understanding of our assets, and application of that knowledge to development programs. Additionally, they willrepresentclinical pharmacology in regulatory interactions to enable efficient,datadrivenadvancement of therapies across our neuroscience portfolio.

Key Responsibilities

  • Lead strategy for collection and interpretation of information across in vitro, in vivo, literature of competitive sources, and clinical data to develop a translational knowledge base to Centessa assets

  • Drive doseselectionand optimizationbyintegratingPK, PD, safety, efficacy, andCNSspecificbiomarkers

  • Leadmodelinformeddrug development, including population PK, PK/PD, and exposure-response analyses relevant to CNS targetsand clinical safety

  • Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers

  • Lead clinical pharmacology strategy for CNS and neuroscience programs fromfirstinhumanthrough registrational andpostmarketingstages

  • Design, execute, and interpret clinical pharmacology studies, including FIH,multipleascendingdose, DDI, biopharmaceutics, and patient studies

  • Serve as the clinical pharmacology lead on program teams, clinicalsubteams, and trial working groups

  • Author and oversee clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs)

  • Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting dose justification and labeling discussions

  • Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs

  • Oversee CROs and external vendorsconductingclinical pharmacology and modeling activities

  • Ensuretimelycommunication and clear interpretation of clinical pharmacology results to internal stakeholders

  • Contribute to portfolio strategy, program prioritization, risk mitigation, andlongrangeclinical development planning for CNS assets

  • Serve as asubjectmatterexpert on clinical pharmacology

  • Mentor and develop clinical pharmacology talent as the pipeline and organization grow

  • Ensurehighquality,submissionreadydocumentation aligned with global regulatory standards

Qualifications

  • PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline

  • 10+ years of experience in clinical pharmacology within biopharma, withdemonstratedimpact intranslational science indrug development

  • Strongexpertisein PK, PD, PK/PD integration, exposure-response analyses, and drug-drug interaction assessment

  • Extensive experience developing and executing clinical pharmacology strategies for earlythroughlatestageprograms, including registrational support

  • Demonstrated experience applying quantitative clinical pharmacologyand translationalapproaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS dose selection and optimization

  • Proficiencywith clinical pharmacology tools and platforms such as NONMEM, R, PhoenixWinNonlin,SimCyp, or equivalent

  • Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities

  • Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development

  • Excellent communication, collaboration, and leadership skills with the ability tooperateeffectively in afastpaced, matrixed environment

Work Location

The Senior Director, Clinical Pharmacology role is based in the US, with occasional travel.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$177,000 - $338,800

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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About Eli Lilly

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Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Indianapolis, IN, US

Year founded

1876