Senior Medical Advisor, Clinical Development - Lilly BioMedicines

July 17 2018
Life Sciences
Position Type
Full Time
Organization Type
Job Type
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician {CRP) participates in:the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; 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 (PAA),grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the externalclinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medicar activities in support of demand realization. The CRP serves as a scientific resource for study teams, departments, and others as needed.

The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local andinternationalregulations,laws, guidance's {for example, FDA,ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.

Core Job Responsibilities

The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds.

The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Clinical Planning
  • Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider,and payer):the product lifecycle plan,clinical strategies, development plans and study protocoldesign.
  • Contribute to business unit and global alignment of clinical strategy and clinical plans.
  • Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial Execution and Support

  • Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports} according to the agreed upon project timel ne.
  • Provides oversight and input into ICDs
  • Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance reviewinteractions}.
  • Review andapprove risk profiles to ensure 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 administrat ve requirements for study initiation and conduct (for example, ethical review board,informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) andlocallaws and requirements.
  • Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
  • Serve as resource to clincal operations personnel I clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
  • Understand and actively address the scientific information needs of all investigators and personnel.
  • 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.
  • Review llT proposals and publications,as requested by Director-Medical.
Scientific Data Dissemination/Exchange
  • Establish and maintain appropriate collaborations and relationships with external experts,thought leaders, and the general medicalcommunity on a local,national,regional and possibly international basis.
  • Develop and maintain appropriate collaborations and relationships with relevant professionalsocieties.
  • Participate in data analysis, development of scientific data dissemination, and preparation of finalreports and publications.
Regulatory Support Activities
  • Participate in development and review of fabel changes and labeling modifications in collaboration with affi iates, brand teams, regulatory,and legal.
  • Provide medical expertise to regulatory screntlsts
  • Support I assist inthe preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
  • Participate in advisory committees.
  • Participate in risk management planning along with affiiates and Global Patient Safety (GPS).

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.

Basic Qualifications
  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified In appropriate specialty/subspecialty or have completed the comparable levelof post-medical school clinicaltraining relevant to the country of hiring.US trained physicians must have achieved board eligibility or certification.
  • Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer. Non-US trained physicians must have completed education and training at a medical schoolthat meets the requirements of the Uaison Committee on Medical Education (LCME).

Additional Skills/Preferences
  • Demonstrated knowledge of drug development process
  • Fluent in English; both written and verbal communications
  • Demonstrated strong communication,interpersonal,organizational,teamwork and negotiation skills
  • Demonstrated ability to influence others (both cross-functionally and within the function)in order to create a positive working environment.
  • Abi ity to engage in domestic and international travel to the degree appropriate to support the business of the team.

Additional Information
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

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