Director PKPD

| Indianapolis, IN
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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 35,000 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.

Chorus Overview:

Chorus, a Division of Lilly Research Laboratories, is a virtual development organization that specializes in efficient proof-of-concept studies and seeks to advance a portfolio of New Molecular Entities to value inflection point with speed and cost effectiveness. Chorus collaborates with internal and/or external stakeholders to refine strategy to maximize pipeline impacts, and with a network of external partners to execute and deliver-manufacture clinical trial material, devise development plan, and conduct studies from IND enabling to clinical proof-of-concept.

Since its creation in 2002, Chorus has supported over 80 assets (a mix of Lilly-sponsored and externally sponsored programs), three of which have progressed to phase 3 and subsequently marketed products.

The Chorus PK/PD Principal Research Scientist role requires:
  • Curiosity
  • Accountability
  • Commitment to essentialism, simplicity, and focus
  • A drive to innovate, and a tolerance for risk, in order to accelerate projects

The Chorus Pharmacokinetics/Pharmacodynamics (PK/PD) Principal Research Scientist serves as functional leader for programs from IND enabling to clinical proof-of-concept. For assigned assets, the PK/PD Principal Research Scientist is responsible for utilizing the principles of quantitative pharmacology to ensure the relevance and rigor of preclinical and clinical strategies, plans and execution.
  • Provide PK/PD/Pharmacometric and scientific leadership to program teams to support the selection of the right molecule, dose, patient population, and development strategies.
  • Is responsible for the consistency, quality, compliance, and timeliness of clinical PK and PK/PD deliverables, such as clinical protocols, PK and PK/PD analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general standards, guidelines, and procedures.
  • Understand and anticipate the high-level issues affecting the drug development process and help derive at effective solutions. Support decision-making through collaboration in cross-functional teams.
  • Develop modeling and simulation (M&S) strategies and plans to enhance the informativeness and efficiency of clinical studies
  • Lead, network, identify and manage all PK/PD and general pharmacometric outsourcing/third party vendor relationships and deliver project milestones on time, on budget, and within scope

Basic Qualifications:
  • MS or PhD in pharmacokinetics, pharmacy, health-related, scientific or engineering field
  • At least 5 years of experience (PhD) or 8 years (MS) from industry, regulatory, consulting or academia with exposure to industry.
  • Demonstrated experience of clinical pharmacology (PK, PD and pharmacometrics) principles, proficient in PK computer software

Additional Skills/Preference
  • Deep knowledge of the drug development process, especially early phase drug development (phase I-II)
  • Solid understanding/prior experience in ADME
  • Experience in various therapeutic areas, including oncology, diabetes, neurosciences, CV, or autoimmune
  • Experience in bioassay development
  • Embrace openness towards cultural diversity, including different work styles; Skilled at managing alliance/CRO relationships
  • Demonstrated leadership abilities/behaviors, particularly entrepreneurial mindset, strategic thinking and teamwork
  • Demonstrated communication/interpersonal skills and ability to connect and influence at various levels across disciplines, both externally and internally.

Additional Information
  • This role will be reporting to the Chorus Chief Development Officer
  • Willing to engage in domestic and international travel to the degree appropriate to support the business of the team

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected]
More Information on Eli Lilly and Company
Eli Lilly and Company operates in the Biotech industry. The company is located in Indianapolis, IN and Indianapolis, IN. Eli Lilly and Company was founded in 1876. It has 39451 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 107 open jobs at Eli Lilly and Company, click here.
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