Director – Clinical Research Scientist

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

📋 Description

• Offer scientific and clinical insight throughout the drug development lifecycle and in all phases of clinical trials.

• Create and contribute to the global medical strategy and clinical trials, spanning from trial design to regulatory submission and post-launch support.

• Collaborate with the Clinical Global Head in Pain and Neuroscience along with cross-functional stakeholders on discovery and clinical development compounds.

• Comprehend pre-clinical and clinical data pertinent to molecules within the Pain and Neuroscience therapeutic area.

• Participate in shaping global clinical strategy, clinical plans, launch label strategy, value proposition, and lifecycle management.

• Work in partnership with Discovery, Program Medicine, Clinical Pharmacology, Medical Affairs, and business-unit teams on study design, clinical strategies, medical plans, and protocols.

• Align protocol design, execution, and reporting, and provide guidance on the tactical implementation of development plans.

• Review and contribute to briefing documents, protocols, investigator brochures, study reports, and regulatory submissions.

• Assess and approve local informed consent documents and risk profiles.

• Oversee patient safety and monitor adverse events, ensuring follow-up as needed.

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

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

• Organize analyses of clinical study data and lead the interpretation of findings.

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

• Report clinical trial data in Clinical Trial Registry activities.

• Aid in data analysis and the creation of slide presentations, study reports, abstracts, posters, and manuscripts.

• Facilitate symposia, advisory boards, congresses, and healthcare professional meetings.

• Prepare or review scientific information in response to investigator inquiries and media requests.

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

• Provide training for investigators, site personnel, and Lilly medical staff.

• Offer scientific/medical technical support during due diligence processes.

• Address unsolicited scientific inquiries from healthcare professionals.

• Engage in local labeling, modifications, regulatory reports, NDAs, annual reports, PADERs, regulatory strategy, and advisory committees.

• Assist in local registration efforts and the resolution of regulatory challenges.

• Collaborate with brand and marketing teams on medical strategies, commercialization, Phase 3b/4 studies, payer requirements, promotional materials, and product value defense.

• Mentor and train clinical study teams and colleagues.

• Participate in DEI, coaching, and continuous improvement initiatives.

⛳️ Requirements

• An advanced degree (PharmD, PhD, DVM, MSN/NP, or a related field) along with a minimum of 5 years of clinical or pharmaceutical experience, OR a BS/MS in a health, medical, or scientific discipline with 7–10 years of pertinent pharmaceutical experience in clinical trials, drug development, or related fields.

• For candidates with drug discovery or drug development experience but lacking direct clinical trial experience: 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 effectively.

• Excellent communication, interpersonal, and negotiation skills.

• Capacity to influence across different functions.

• Readiness to travel domestically and internationally as necessary.

• Proficiency in English, both written and verbal.

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

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

• Awareness of and compliance with local laws, regulations, and global policies and procedures.

• Maintain necessary training and compliance certifications.

🏝️ Benefits

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

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• 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, which include an employee assistance program, fitness benefits, and opportunities for employee clubs and activities.