Senior Operations Specialist

2 weeks ago


Indiana, Pennsylvania, United States Eli Lilly Full time

Position Overview:

As a pivotal member of the PK/PD Operations Team at Eli Lilly, you will contribute significantly to the operational framework of our drug discovery and clinical development initiatives. This role requires collaboration with PK/PD scientists and cross-functional teams to ensure the timely and high-quality delivery of key pharmacokinetics and pharmacodynamics (PK/PD) outputs.

Key Responsibilities:

  1. PK/PD Process Management: Work alongside PK/PD scientists to formulate data analysis strategies, manage timelines for document preparation, and coordinate the drafting of essential PK/PD documentation.
  2. Data Oversight & Analysis: Partner with data management teams to guarantee precise collection, processing, and analysis of PK/PD data, adhering to established protocols. Create and review clinical trial datasets for critical PK evaluations and conduct basic PK/PD analyses.
  3. Operational Issue Resolution: Proactively identify and address operational challenges, implementing effective solutions to mitigate risks and ensure successful delivery of analyses and documentation.
  4. Continuous Improvement Initiatives: Engage in process enhancement projects to improve the efficiency and quality of PK/PD operations, utilizing best practices and innovative strategies.
  5. Vendor Coordination: Manage relationships with external vendors, including Contract Research Organizations (CROs), to ensure the timely delivery of high-quality studies and analyses.
  6. Regulatory Compliance: Contribute to the writing and revision of departmental Standard Operating Procedures (SOPs) and ensure adherence to relevant regulatory guidelines.
  7. Cross-Functional Collaboration: Collaborate with various teams to drive integrated PK/PD strategies and meet project milestones, serving as a PK/PD Operations expert in inter-departmental committees.

Qualifications:

Applicants should possess a BSc or MS in a relevant scientific discipline, such as biological sciences, chemistry, engineering, or data science. Strong communication and interpersonal skills are essential for effective collaboration with both internal and external stakeholders.

Preferred Skills:

  • Understanding of clinical pharmacology principles.
  • Familiarity with programming or statistical languages.
  • Experience in project management with strong organizational skills.
  • Ability to work independently and adapt to changing priorities in a dynamic environment.

At Eli Lilly, we are dedicated to fostering a diverse and inclusive workplace, ensuring that all employees feel valued and empowered to contribute to our mission of improving lives through innovative healthcare solutions.



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