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Clinical Pharmacologist - Immunology

Indianapolis, Indiana

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Req ID R-12054 Title Clinical Pharmacologist - Immunology City Indianapolis State / Province Indiana Country United States

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.

Title

Clinical Pharmacologist - Immunology

Location

Global

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.

Responsibilities

Through the application of pharmacological training, expertise and relevant therapeutic area experience , the Clinical Pharmacologist (CP) 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 CP 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 CP serves as a scientific resource for study teams, departments, and others as needed.
The CP 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 CP 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.

  • 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 drug­ disease response models.

  • Contribute, as an integral member of the Clinical Pharmacology team, to global 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 clinical trial managers, 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.

 
Regulatory 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.

People Management and Development:

  • Develop, and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience

  • Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness

  • Develop an organizational talent base that demonstrates judgment-based risk taking and decision making

  • Business customer support (pre and post launch support )

Basic Qualifications

  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.

  • Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).  For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm

Additional Skills/Preferences

  • Experience in Clinical Immunology, Rheumatology or Dermatology preferred

  • PhD preferred

  • Knowledge of and experience in Clinical Pharmacology and drug development process

  • 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.



Additional 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

  • Operational Staff

  • 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

For internal employees, if you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-12054.

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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