Director - Clinical Research Scientist - Global and US Medical Affairs

Eli Lilly and Company•Us, IN

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary The Clinical Research Scientist (CRS) within the Business Unit – Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans.

Requirements

An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience

Nice To Haves

Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
Ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s)
External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders

Responsibilities

Business & Customer Support Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
Lead data analyses and health outcomes research to address customer questions.
Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements.
Support training of sales, medical, and patient support teams.
Lead definition of Patient Journey and contribute clinical perspective to patient programs.
Participate in relevant professional and industry associations.
Scientific Exchange & Data Dissemination Ensure compliance with global and local regulations governing scientific communication.
Address unsolicited scientific inquiries in alignment with medical governance standards.
Support scientific meetings, advisory boards, symposia, and other expert engagements.
Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts.
Build and maintain relationships with key opinion leaders and scientific societies.
Represent the company at medical congresses and support scientific booth activities.
Contribute to data analyses, publication development, and Clinical Trial Registry reporting.
Clinical Planning Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
Communicate local research needs to ensure Phase I–IV programs reflect market and customer requirements.
Maintain up‑to‑date understanding of clinical and competitive data.
Provide regional clinical insights to inform development plans and study protocols.
Clinical Research Execution Review and approve informed consent documents to ensure accurate risk communication.
Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out.
Support investigator/site training and address study‑related medical questions.
Oversee local safety monitoring and adverse event follow‑up.
Review investigator‑initiated trial (IIT) proposals as needed.
Ensure global alignment of Phase 3b/4 and applicable early‑phase studies.
Regulatory Support Contribute to development and review of local labeling and labeling changes.
Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
Participate in risk management planning with global and local teams.
Scientific & Professional Development Stay informed on therapeutic area trends, market changes, and competitive landscape.
Provide scientific training to clinical study teams and act as a protocol subject‑matter expert.
Represent the organization at medical congresses and contribute to medical budget planning.
Seek opportunities for external scientific engagement.
Leadership & Collaboration Set and pursue professional development goals and support growth of colleagues and direct reports.
Contribute to recruitment, diversity, and retention efforts when applicable.
Participate in committees, Six Sigma initiatives, and cross‑functional projects.
Model leadership behaviors and serve as an ambassador for patients and the company.

Benefits

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).

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