Physician- Clinical Pharmacologist
Eli Lilly - Indianapolis, IN

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Through application of scientific training, clinical expertise and relevant experience, particularly in the inflammatory diseases area, 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.
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.

KEY OBJECTIVES/DELIVERABLES:
The primary responsibilities of the Clinical Pharmacology CRP – AI, are generally related to early-phase compounds in the inflammation and autoimmunity diseases area.

The core job responsibilities include those listed below 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. Support preparation of high-level plan for phase 2 and 3 studies.
  • Collaborate with other functional areas (Global Patient Safety, PK/PD, Diagnostic and Experimental Medicine) in the development of methods for assessing special clinical safety pharmacology studies (e.g. TQT 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 with a particular but not exclusive concentration in the inflammatory and autoimmune diseases area.
  • Contribute, as an integral member of the Clinical Pharmacology team, to global alignment of Phase I and II clinical studies
  • Work closely with discovery research scientists, especially large molecule and AI scientists, in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
Clinical Research/Trial Execution and Support
  • Design and oversee implementation of all clinical pharmacology studies, particularly in the inflammatory diseases area. Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers.
  • Apply fundamental concepts of inflammatory and autoimmune pathophysiology, clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
  • Design and oversee implementation methods for development and biomarker qualification studies, particularly in the inflammatory diseases area.
  • 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 clinical team.
  • Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects.
  • Ensure 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 / 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.
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 / 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.
  • Develop and review labeling modifications in collaboration with regulatory and safety groups.
  • Participate in risk management planning along with GPS colleagues.
  • Provide medical expertise to regulatory scientists.
Business/ customer support (pre and post launch support)
  • Understand the scientific information needs of all Clinical Pharmacology customers (regulators, clinical researchers, health care providers, patients, payers).
  • Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national, regional, and possibly international basis.
  • Develop and maintain appropriate collaborations and relationships with relevant professional societies, and scientific and medical organizations on local and possibly international scale.
  • Prepare or review scientific information in response to customer questions or media requests.
  • Contribute as scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
  • Participate in patent development.
  • Provide advice and consultation to global business unit with regard to potential markets for development compounds and in-licensed projects or compounds.
  • Actively address customer (regulators and other clinical scientists) questions in a timely fashion by leading data analyses and new clinical research efforts.
Scientific / Technical Expertise and continued development
  • Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product, particularly in the inflammatory diseases area.
  • Knowledge of current trends and projections for clinical practice and access especially, but not limited to, the inflammatory and autoimmunity diseases area.
  • Explore and take advantage of opportunities for extramural scientific experiences
  • Attend scientific symposia
  • Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule
  • Maintain awareness of current clinical practices through experience or contacts
  • May participate in limited medical practice (volunteer)
General Responsibilities
  • Support the management team, including the medical director, in preparation and administration of the Clinical Pharmacology budget
  • Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers
  • Actively participate in recruitment, diversity, and retention efforts
  • Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management
  • Model the leadership behaviors outlined in the ‘On Leadership’ White Paper
  • Be an ambassador for the Lilly Brand
MINIMUM REQUIREMENTS:
  • 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.
o Foreign medical graduates 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
  • Demonstrable scientific expertise in inflammation and autoimmunity pathophysiology as evidenced by a publication record in the area. A PhD concerning inflammation or autoimmune diseases is preferable.
ADDITIONAL SKILLS/PREFERENCES;

  • Demonstrable scientific expertise in inflammation and autoimmunity pathophysiology as evidenced by a publication record in the area. A PhD concerning inflammation or autoimmune diseases is preferable.
  • 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.
OTHER INFORMATION:
  • Located in Indianapolis, IN
  • Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors. Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community. The following is a selection of awards and recognition Lilly has received in recent years:

Awards and Recognition

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