Lilly Principal Research Scientist-Insulins & Devices in Indianapolis, Indiana

33900BR

Title Principal Research Scientist-Insulins & Devices

City Indianapolis

State / Province Indiana

Country USA

Company Overview 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 39,000 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.

Responsibilities Through application of scientific training, clinical expertise and relevant experience, the U.S. Business Unit Medical Affairs clinical research scientist participates in: the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in U.S.; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the CRP or Sr. Director-Medical, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the brand team(s), global Development team(s), Therapeutic Area Program Phase, Early Phase / Exploratory Program Medicine (EPM), and Translational Medicine team(s). The CRS is an integral member of an affiliate brand team for strategic planning in the support of launch and commercialization activities. The CRS may also work closely with global Development, Therapeutic Area Program Phase, Early Phase / Exploratory Program Medicine (EPM), and Translational Medicine team(s) in new product development activities over the entire spectrum of drug development and clinical trial phases.

The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed.

The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidances (e.g. FDA, ICH, etc.), Good Clinical Practices (GCPs), company standards, CIA agreement, Lilly policies and procedures, and the Principles of Medical Research.

Core Job Responsibilities:

The primary responsibilities of the U.S. Business Unit Medical Affairs CRS are generally related to late-phase and marketed compounds. The CRS is responsible for collaborating/leading the research staff in the planning, startup and conduct of phase 3b/4 studies that are conducted in the U.S. In addition, the CRS, if assigned by the Director or Sr. Director-Medical, is responsible for affiliate support of global Development studies conducted in the U.S.

The core job responsibilities include those listed below as well as other duties as assigned:

  • Clinical Planning

  • Clinical Research/Trial Execution and Support

  • Scientific Data Dissemination/Exchange

  • Regulatory Support Activities

  • Business/ customer support (pre and post launch support)

  • Scientific / Technical Expertise and continued development

  • General Responsibilities

Basic Qualifications

  • Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR

  • BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.

  • 3-5 years of clinical experience, or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development / medical affairs experience.

Additional Skills/Preferences

  • Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field.

  • 3-5 years of clinical experience, or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience.

  • Knowledge of drug development process preferred

  • Fluent in English; both written and verbal communications

  • Interpersonal, organizational and negotiation skills

  • Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.

  • Excellent teamwork skills.

  • Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.

  • Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skill

Additional Information

Primary internal interactions

  • Director(s)-Clinical Operations, managers or project managers

  • CDLs, CTMs, CRPs, TAs, other research staff

  • Statisticians

  • Scientific communication associates

  • Medical information associates

  • Medical liaisons

  • Health outcomes research consultants/research scientists and health outcome liaisons

  • Regulatory directors, scientists, and associates

  • Product directors, managers, and associates of the brand teams

  • Sales district managers and sales representatives

  • Legal counsel

  • Therapeutic area physicians, global brand physicians, early phase physicians, and Director(s)-Medical

  • Global Marketing director or manager

  • Corporate patient safety physician

External Contacts

  • Scientific and clinical experts, thought leaders

  • Lilly clinical investigators

  • Practicing physicians/prescribers

  • Regulatory agency personnel

  • Professional association staff and leaders

  • Disease advocates and lay organizations focused on relevant health issues

  • Formulary representatives (private and government)

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Removal Date 11-Nov-2017