Collaborate with the Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning in the development and maintenance of Draft Launch Labels and Value Propositions that address key customer needs (patient, provider, and payer)
Contribute to global alignment of clinical strategy and clinical plans with business unit and LRL priorities
Understand and keep updated with the pre-clinical and clinical data relevant to molecules
Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials
Review and approve risk profiles to ensure appropriate communication of risk to study subjects
Participate in investigator identification and selection, in conjunction with clinical teams
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct
Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study
Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures
Requirements
Medical Doctor must be board eligible or certified in Nephrology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
Five years of experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials or other qualifying activities
Clinical trialist with a track record of developing clinical plans and execution of studies in the pharmaceutical industry
Ideal would be additional qualification for business acumen
Ideal Five years of experience in clinical practice with at least 2 years renal diseases
Demonstrated evidence for the capacity to lead and manage groups of professionals
Demonstrated administrative skills, including strong team work skills
Demonstrated evidence of the ability to work within Lilly's governance structure
Strong communication, interpersonal, and negotiation skills
Benefits
Competitive salary
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)