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Eli Lilly and Company
Eli Lilly and Company
BiotehnologijaFarmacevtski izdelkiZdravstveno varstvo
Eli Lilly and Company je večnacionalno farmacevtsko in zdravstveno podjetje, osredotočeno na odkrivanje, razvoj, proizvodnjo in trženje zdravil na recept. Njegovo delovanje zajema terapevtska področja, kot so sladkorna bolezen, onkologija, imunologija, nevroznanost in obvladovanje bolečine, pri čemer povezuje raziskave in razvoj s kliničnimi preskušanji, regulativnimi postopki, proizvodnjo bioloških zdravil in zdravil z majhnimi molekulami ter globalno distribucijo.
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Delovna mesta v podjetju

Director, Clinical Research Scientist – Neurodegenerative Disease

Lead early-phase clinical research advancing medicines for Alzheimer’s, Parkinson’s, ALS, and other neurodegenerative diseases. Shape trial design, analyze evidence, and support regulatory development.

USZdružene države Amerike
177.000 $ – 338.800 $ / leto
Na daljavoPolni delovni časVodjaZahtevani Jezik: angleščinaKlinične raziskave

Opis

  • Help shape and deliver early-phase clinical trials for neurodegenerative diseases, from strategy and design through analysis and reporting.
  • Ensure trial work meets FDA, EMA, ICH, Good Clinical Practice, company, and applicable legal requirements.
  • Track preclinical, translational, and clinical evidence relevant to the neurodegeneration portfolio.
  • Contribute to clinical strategy, development plans, protocols, dose and regimen choices, and biomarker and imaging approaches.
  • Represent Lilly in external discussions on neurodegenerative disease standards, assessment tools, and clinical guidelines.
  • Work with the Clinical Research Physician and cross-functional colleagues to develop protocols and conduct trials.
  • Write and review protocols, amendments, informed consent forms, Investigator’s Brochures, statistical analysis plans, and clinical study reports.
  • Prepare study operations documents, training materials, and reference guides.
  • Help design case report forms and plan site selection, study start-up, investigator meetings, site training, and trial operations.
  • Provide scientific guidance to clinical operations teams, monitors, investigators, and ethics review boards.
  • Help monitor participant safety by reviewing adverse events and safety data and following up as needed.
  • Assess clinical, safety, pharmacokinetic, and biomarker data to support data quality and program decisions.
  • Coordinate with clinical operations, contract research organizations, and specialty vendors to maintain scientific integrity, quality, and timely delivery.
  • Contribute to analyses, presentations, reports, publications, trial registration and results disclosure, symposia, and advisory boards.
  • Build relationships with external experts, thought leaders, professional societies, and the medical and scientific community.
  • Help train medical staff and clinical research colleagues in geographic teams and affiliates.
  • Contribute to regulatory documents and interactions with health authorities.
  • Advise study teams as a scientific consultant and protocol expert.
  • Mentor clinical research scientists and study team colleagues; at senior levels, lead cross-functional workstreams and represent the team in governance forums.
  • Maintain professional development objectives and current training and qualification records.

Zahteve

  • Hold an advanced health, medical, or scientific degree (such as a PhD, PharmD, DVM, or MSN with an advanced clinical specialty) and have at least five years of pharmaceutical or clinical research experience, including three years directly designing, managing, and executing trials; alternatively, hold a bachelor’s or master’s degree in a relevant field and have at least ten years of pharmaceutical or clinical research experience, including substantial trial design, management, and execution.
  • Have fluent written and spoken English.
  • Bring direct experience leading trial operations, such as protocol development, case report form design, investigator training, or study monitoring.
  • Have prior experience in neurodegeneration or neuroscience.
  • Understand the diagnosis, pathophysiology, causes, treatment, and management of neurodegenerative disorders.
  • Be familiar with fluid and imaging biomarkers, clinical outcome assessments, diagnostic criteria, and neurodegeneration trial designs.
  • Have experience designing and executing early-phase trials, including first-in-human, dose-escalation, and biomarker-driven proof-of-concept studies.
  • Be proficient with electronic data capture systems, medical listings, and clinical data visualization tools such as Spotfire.
  • Be able to interpret clinical trial efficacy, safety, and biomarker data.
  • Have contributed to regulatory documents and health authority interactions.
  • Have experience working with contract research organizations and specialty vendors.
  • Show scientific contributions in neurodegeneration or neuroscience, such as peer-reviewed publications or congress presentations.
  • Demonstrate skill in critically analyzing, interpreting, and communicating scientific and clinical data.
  • Bring strong communication, interpersonal, teamwork, and organizational skills.
  • Be able to influence cross-functional partners and support a positive, collaborative work environment.
  • Be willing to travel domestically and internationally about 10–20% of the time.
  • Be able to work Eastern Time business hours.

Ugodnosti

  • Company bonus, based in part on company and individual performance.
  • Company-sponsored 401(k) plan.
  • Pension.
  • Vacation benefits.
  • Medical, dental, vision, and prescription drug coverage.
  • Flexible benefits, including healthcare and/or dependent care flexible spending accounts.
  • Life insurance and death benefits.
  • Time off and leave benefits.
  • Well-being offerings, including an employee assistance program, fitness benefits, and employee clubs and activities.
  • Remote-flexible work within the United States.

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Na daljavoPolni delovni časSeniorZahtevani Jezik: angleščinaOblikovalec

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