Title Physician - Oncology
State / Province Indiana
Position Locale Local / Onsite
Location Details Indianapolis
Company Overview Eli Lilly and Company has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a Best in Class” Pharmaceutical company, please review the following opportunity.
Through application of scientific training, clinical expertise, and relevant experience, the U.S. Oncology Clinical Development and Medical Affairs Clinical Research Physician (CRP) participates in: the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in U.S. ; the reporting of adverse events; 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 (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. The CRP is an integral member of an affiliate brand team for strategic planning in the support of launch and commercialization activities. The CRP may also work closely with global Development, Program Phase, Early Phase / Exploratory Program Medicine (EPM), and Translational Medicine team(s) in new product development activities over the entire spectrum of drug development and clinical trial phases.
The CRP 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, CIA agreement, Lilly policies and procedures, and the Principles of Medical Research.
The primary responsibilities of the CRP are generally related to late-phase and marketed compounds, but significant time is spent on supporting implementation of global pivotal trials in our late phase portfolio as well as early phase development. The CRP is responsible for collaborating with local and global research staff in the planning, startup and conducting of phase 2-3, 3b/4 studies that are conducted in the U.S.
Communicate and collaborate with Medical Director to ensure life cycle plans for drugs in development address affiliate customer needs.
Communicate local research needs and collaborate with other regions and the global Development team, Global Health Outcomes (GHO), and PRA teams to ensure Phase 3, 3b, and 4 clinical programs meet the needs of local/regional customers.
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Represent the clinical needs of the affiliate to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
Clinical Research/Trial Execution and Support
Review and approve local informed consent documents to ensure appropriate communication of risk to study subjects.
Collaborate with clinical research staff in the design, conducting and reporting of local clinical trials.
Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, Statisticians, GHO, research scientists and selected investigators in the development of protocols and data collection requirements.
Participate in investigator identification and selection.
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct 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 research site monitors, investigators and ethical review boards.
Contribute to global alignment of Phase 3b/4 clinical studies planned by U.S. with global Development.
Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events.
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.
Understand and actively address the unsolicited scientific information needs of external health care professionals.
Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
Support medical information associates in preparation and review of medical letters and other medical information materials.
Support training of local medical personnel, including medical and outcome liaisons and health outcomes staff.
Prepare or review scientific information in response to customer questions or media requests
Support data analysis and the development slide sets and publications (abstracts, posters, manuscripts).
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Regulatory Support Activities
Participate in development and review of local labeling and labeling.
Provide medical expertise to regulatory scientists.
Support assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate perspective.
Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).
Business/ customer support (pre and post launch support)
Understand the scientific information needs of all Affiliate customers (payers, patients, health care providers).
Contribute to the development of medical strategies to support brand commercialization activities by working closely with cross-functional teams.
Actively address affiliate customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
Support business-to-business and business-to-government activities as medical expert.
Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.
Contribute as a scientific and medical expert to activities and deliverables of the PRA organization.
Review, offer scientific and creative support for, and approve promotional materials for brand team.
Support training of sales representatives.
Become familiar with market archetypes and potential influence on the medical interventions for the product.
Scientific / Technical Expertise and continued development
Aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product.
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
Attend and participate in medical congresses/scientific symposia.
* 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 ofhiring.
* 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, seehttp://www.in.gov/pla/2799.htm
* Excellent English communication (written and verbal),
interpersonal, organizational and negotiation skills
* Demonstrated ability to influence others (both
cross-functionally and within the function) in order to create a positive
* Demonstrated leadership and teamwork skills.
* Clinical and clinical trial expertise in GI cancer.
* Experience with lecturing, teaching, and/or
writing about GI cancer
* Translational research experience
(e.g. biomarkers), particularly in GI cancer.
* Knowledge of the drug development
process, particularly within the US.
* Pharmaceutical medicine experience
Additional Information • Position located in Indianapolis, IN
• Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
Removal Date 13-Aug-2014