Director – Clinical Research Scientist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $177k - $338.8k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 Description

• Provide scientific and clinical expertise across the drug development lifecycle and all clinical trial phases • Develop and contribute to global medical plans and clinical strategies for Pain and Neuroscience compounds • Support clinical trial development and conduct from trial design through regulatory submission and post-launch support • Partner with cross-functional teams on study design, clinical strategies, medical plans, and protocols • Align on protocol design, conduct, reporting, sample size, timelines, data collection, grants, and governance reviews • Review and contribute to briefing documents, protocols, investigator brochures, study reports, and submissions • Review and approve local informed consent documents and risk profiles • Monitor patient safety and track and follow up on adverse events • Support investigator selection, site training, and study start-up • Serve as a scientific resource to clinical operations, investigators, and ethics boards • Plan clinical study data analysis and lead interpretation of results • Support first-in-human, PK/PD-driven, and biomarker-driven proof-of-concept trial design • Participate in clinical trial registry reporting • Support data analysis and development of slide sets, final study reports, abstracts, posters, and manuscripts • Support symposia, advisory boards, congress activities, and healthcare professional meetings • Prepare or review scientific information for investigator questions or media requests • Establish relationships with external experts, thought leaders, investigators, professional societies, and the medical community • Train investigators, site personnel, and Lilly medical personnel • Provide scientific/medical technical support for due diligence • Respond to unsolicited scientific inquiries from healthcare professionals • Support local labeling, labeling modifications, regulatory reports, NDAs, annual reports, PADERs, regulatory strategy, advisory committees, and local registration efforts • Partner with brand and marketing teams on medical strategies, commercialization, Phase 3b/4 studies, payer programs, product value defense, and promotional materials • Mentor and train clinical study teams and colleagues • Participate in DEI, coaching, and continuous improvement initiatives

🎯 Requirements

• Advanced degree (PharmD, PhD, DVM, MSN/NP, or related) plus 5+ years of clinical or pharmaceutical experience, OR BS/MS in a health, medical, or scientific field plus 7–10 years of relevant pharmaceutical experience • Relevant experience in clinical trials, drug development, epidemiology, toxicology, pharmacology, regulatory/medical affairs, or related areas • Candidates with only drug discovery or drug development experience must provide documented ownership of medical/scientific content development and endorsement from BU Medical Affairs/Development VP or senior leadership • Ability to balance scientific and business priorities • Strong communication, interpersonal, and negotiation skills • Ability to influence cross-functionally • Willingness to travel domestically and internationally as needed • Fluency in English, written and verbal • Maintain required training/compliance certifications • Knowledge of diagnosis, pathophysiology, etiology, treatment, and management of Pain and Neurologic Disease • Knowledge of clinical research methodology, biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards • Knowledge of applicable local laws, regulations, and global policies and procedures

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups open to all employees