Director - Clinical Research Scientist

Job Title: Director - Clinical Research Scientist

Job Location: Remote, Indiana, United States of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

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.

Role Overview

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.

Key Responsibilities

Clinical Planning

• 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.

Clinical Trial Execution

• 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.

Scientific Acumen and Communication

• 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 collaborations and relationships with external experts, thought leaders, investigators, and the general medical community on a national and international basis.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies including those concerned with Pain and Neuroscience Therapeutic area.
• Train investigators and site personnel in clinical study design and protocol implementation.
• Support relevant training of Lilly medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and health outcomes personnel.
• Provide scientific/medical technical support for due diligence activities as needed.
• Respond to unsolicited scientific inquiries from healthcare professionals per company guidelines.

Regulatory Support

• Participate in development and review of local labeling and labeling modifications in collaboration with brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists.
• Contribute to preparation of regulatory reports and submissions (NDAs, annual reports, PADERs). Provide medical/scientific input for regulatory strategy and advisory committees.

Support local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.

Business & Commercial Support

• Partner with brand and marketing teams to contribute to the development of medical strategies to support brand commercialization strategy during the development of business plans by identifying Phase 3b/4 studies to answer key customer questions and meet needs.
• Address scientific information needs of payers, patients, and providers by conducting Phase 3b/4 studies, new data analyses or health outcomes research efforts.
• Support payer partnership programs and product value defense
• Contribute medical/scientific input to the brand team to support development of promotional materials

Professional Development & Leadership

• Contribute to the development of medical strategies in support of the Global Pain and Neuroscience strategy and commercialization by working closely with business unit colleagues.
• Understand the scientific information needs of all affiliate customers (payers, patients, health care providers).
• Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.

• Mentor and train clinical study teams and colleagues.
• Maintain required training/compliance certifications.
• Participate in DEI, coaching, and continuous improvement initiatives.

Minimum Qualifications

• 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 in clinical trials, drug development, or related areas (e.g., epidemiology, toxicology, pharmacology, regulatory/medical affairs)

If a candidate's experience is in drug discovery or drug development only (no direct clinical trial experience), additional supporting evidence is required, including:

• Documented ownership of medical/scientific content development
• Endorsement from BU Medical Affairs/Development VP or senior leadership

All candidates must demonstrate:

• Demonstrated ability to balance scientific and business priorities
• Strong communication, interpersonal, and negotiation skills
• Ability to influence cross-functionally
• Willingness to travel domestically/internationally as needed
• Fluency in English (written and verbal)

Key Stakeholders

Internal: Clinical operations, medical affairs, regulatory, legal, statistics, brand/marketing teams, sales External: Investigators, thought leaders, regulatory agencies, professional associations, patient advocacy groups

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

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Originally posted on Himalayas