Director – Clinical Research Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver scientific and clinical expertise throughout the entire drug development lifecycle and across all phases of clinical trials.

• Create and contribute to global medical plans and clinical strategies for compounds related to Pain and Neuroscience.

• Aid in the development and execution of clinical trials, from trial design to regulatory submission and post-launch support.

• Collaborate with cross-functional teams on study design, clinical strategies, medical plans, and protocols.

• Ensure alignment on protocol design, execution, 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.

• Assist in investigator selection, site training, and study initiation.

• Act as a scientific resource for clinical operations, investigators, and ethics boards.

• Plan clinical study data analysis and lead the interpretation of results.

• Support the design of first-in-human, PK/PD-driven, and biomarker-driven proof-of-concept trials.

• Participate in clinical trial registry reporting.

• Assist in data analysis and the creation of slide sets, final study reports, abstracts, posters, and manuscripts.

• Support symposia, advisory boards, congress activities, and meetings with healthcare professionals.

• Prepare or review scientific information for inquiries from investigators or media requests.

• Build relationships with external experts, thought leaders, investigators, professional societies, and the medical community.

• Train investigators, site personnel, and Lilly medical staff.

• Provide scientific and medical technical support for due diligence processes.

• Respond to unsolicited scientific inquiries from healthcare professionals.

• Assist with local labeling, labeling modifications, regulatory reports, NDAs, annual reports, PADERs, regulatory strategy, advisory committees, and local registration initiatives.

• Collaborate 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.

• Engage in DEI initiatives, coaching, and continuous improvement efforts.

⛳️ Requirements

• An advanced degree (PharmD, PhD, DVM, MSN/NP, or equivalent) with 5+ years of clinical or pharmaceutical experience, OR a BS/MS in a health, medical, or scientific field with 7–10 years of relevant pharmaceutical experience.

• Experience in clinical trials, drug development, epidemiology, toxicology, pharmacology, regulatory/medical affairs, or related areas.

• Candidates with experience solely in drug discovery or drug development must demonstrate documented ownership of medical/scientific content development and have endorsement from BU Medical Affairs/Development VP or senior leadership.

• Ability to balance scientific and business priorities effectively.

• Excellent communication, interpersonal, and negotiation skills.

• Ability to influence across functional teams.

• Willingness to travel domestically and internationally as needed.

• Proficiency in English, both written and verbal.

• Maintain necessary training and compliance certifications.

• Knowledge of the diagnosis, pathophysiology, etiology, treatment, and management of Pain and Neurologic Diseases.

• Familiarity with clinical research methodologies, biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards.

• Understanding of applicable local laws, regulations, and global policies and procedures.

🏝️ Benefits

• Company bonus based partly on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug benefits.

• Flexible benefits, which include healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and clubs and activities for employees.

• Employee resource groups available to all employees.