Sr Medical Advisor

Employer
Lilly
Location
Indianapolis, Indiana
Salary
Competitive
Posted
July 17 2019
Ref
51054BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Through the application of scientific and medical training, clinical expertise and relevant clinical experience , the Clinical Pharmacology Clinical Research Physician (CRP) participates in the following: the development, conduct and reporting of global clinical trials for new compounds, 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, grant submissions and contracts, contacts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders. In addition, the clinical research physician works with the basic research scientists to identify lead compounds and plan pre-clinical studies as well as network with the Business Unit to plan for the clinical pharmacology submission package. The CRP serves as a scientific resource for study teams, departments, and others as needed.

The Clinical Research Physician is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision.

Core Job Responsibilities
The primary responsibilities of the Clinical Pharmacology CRP are generally related to clinical pharmacology including early phase exploratory and late phase biopharm submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

Clinical Planning
  • Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission. Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharm plan to support submission.
  • Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies (e.g. TOT studies).
Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drugĀ­ disease response models.
  • Contribute, as an integral member of the Clinical Pharmacology team, to global alignment of Phase I and II clinical studies as well as submission planning activities.
  • Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
  • Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharm submission plan.
Clinical Research/Trial Execution and Support
  • Design and oversee implementation of all clinical pharmacology studies. Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations.
  • Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
  • Design and oversee implementation methods for development and biomarker qualification studies.
  • Design, create, and provide oversight for protocol development.
  • Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements.
  • Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
  • Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group.
  • Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects.
  • Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws 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 CTMs 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 global patient safety policies and procedures.
  • Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety.
  • Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution.
Scientific Data Dissemination/Exchange
  • Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
  • Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above.
  • Participate in reporting of clinical trial data in Clinical Trial Registry activities.
  • Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process.
  • Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies.
  • Publish results of research projects as appropriate.
  • Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
  • Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
  • Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials.
  • Provide clinical reports for local and international regulatory purposes.

Requlatory Support Activities
  • Support I assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.

Business customer support (pre and post launch support )

Scientific I Technical Expertise and continued development

General Responsibilities

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.

#WeAreLilly

Basic Qualifications

  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training 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. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME


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.

OTHER INFORMATION - role will require interaction with many of the following: Internal
  • Therapeutic area physicians, global brand physicians, early phase physicians, and directors-medical
  • PK/PD, Modeling & Simulation, ADME, Toxicology
  • Statisticians
  • Discovery Scientists
  • Advisors-Clinical Project Management
  • Clinical research staff (CTM, CPM)
  • Health outcomes research consultants/research scientists and health outcome liaisons
  • Regulatory directors, scientists, and associates
  • Product directors, managers, and associates of the brand teams
  • Legal counsel
  • Corporate patient safety physician
External
  • 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)


Additional Skills/Preferences

  • Clinical research or pharmaceutical medicine experience preferred
  • 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.

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