Director - Clinical Research Scientist

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.

The Global Pain Clinical Research Scientist (CRS) provides scientific and clinical expertise across the drug development lifecycle and over the entire spectrum of clinical trial phases. Specific activities include developing and contributing to the global medical plan and the development and conduct of clinical trials from trial design through regulatory submission and post-launch support. This role bridges clinical science with business strategy and the CRS serves as a scientific/medical resource for study teams, departments, and others as needed.

The CRS is aware of and ensures that all activities comply with applicable regulations (FDA, ICH, GCP), company policy, and Lilly's medical principles. Through application of scientific training, clinical expertise and relevant experience, the CRS will work collaboratively with the Clinical Global Head in the Pain and Neuroscience and cross-functional stakeholders (as assigned) on compounds in discovery research, throughout the clinical development lifecycle, and with respective Medical Affairs and business unit brand team(s) on compounds in the Pain and Neuroscience therapeutic area.

• Understand and remain updated with the pre-clinical and clinical data relevant to the molecule(s) in the Pain and Neuroscience therapeutic area.
• Contribute to global alignment of clinical strategy and clinical plans consistent with LRL and NBU priorities in the Pain therapeutic and neuroscience area strategy.
• Ensure life cycle plans for drugs in development, address customer needs and collaborate with Brand Team, Regional Medical Leader, Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 clinical programs meet the needs of local/regional customers.
• Contribute to launch label strategy, value proposition, and lifecycle planning representing the clinical needs of the country/region.
• Partner with cross-functional teams (Discovery, Program Medicine, Clinical Pharmacology, Medical Affairs, and business unit) on study design, development of clinical strategies and medical plans, and study protocol design.

• Work collaboratively with cross-functional stakeholders (as assigned) to align on the protocol design, conduct and reporting of clinical trials (e.g., sample size, patient commitment, timelines, data collection requirements, grants, and governance review interactions) and advise on tactical execution of development plans and strategy.
• Review and contribute to briefing documents, protocols, investigator brochures, study reports, and submissions.
• Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.
• Monitor patient safety and conduct adverse event tracking and follow-up.
• Support investigator selection, site training, and study start-up activities to provide the appropriate scientific training and information to investigators and site personnel.
• Serve as scientific resource to clinical operations, investigators, and ethics boards to address any questions or clarify any issues arising during the conduct of the study.
• Plan clinical study data analysis and lead interpretation of clinical study results.
• Support first-in-human clinical trial design, PK/PD-driven design and biomarker-driven proof-of-concept.

• Have knowledge of and maintain compliance with local laws and regulations, and global policies and procedures.
• Knowledge of diagnosis, pathophysiology, etiology, treatment and management of Pain and Neurologic Disease associated with different conditions.
• Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.
• Support data analysis and development of slide sets, final study reports and publications (abstracts, posters, manuscripts).
• Support the planning of symposia, advisory board meetings, congress activities, and other meetings with health care professionals.
• Prepare or review scientific information in response to investigator questions or media requests.
• Establish and maintain appropriate…