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Eli Lilly and Company

Senior Medical Advisor Neuro Pain

Eli Lilly and Company - Indianapolis, IN

Responsibilities Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit - Medical Affairs Clinical Research Physician (CRP) is an integral member of the medical affairs, development team for strategic planning in the support of launch and commercialization activities of pain molecules (Tanezumab). Specific activities include developing or contributing to the regional clinical\/medical plan; the development, conduct and reporting of local clinical trials; the reporting of adverse events as mandated by corporate patient safety; 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.\u00a0 In addition, the CRP is responsible for assuring that his\/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase \/ Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed.\u00a0 \u00a0 Some specific activites: Business\/ customer support (pre and post launch support) Understand and anticipate the scientific information needs of payers, patients, health care providers Actively address payer, patient and health care providers questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes\/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. Contribute actively on an ongoing basis to the strategic planning for currently marketed brands. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. Become familiar with market archetypes and potential influence on the medical interventions for the product. Scientific Data Dissemination\/Exchange Support the planning of symposia, advisory board meetings, and and\/or the facilitation of 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\/or 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 of slide sets (through reviewing and\/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications. Clinical Planning Collaborate as needed to ensure life cycle plans for drugs in development Communicate local\/regional research needs. Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Represent the clinical needs of the country to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research\/Trial Execution and Support 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 review interactions). Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the clinical operations 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 the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Review IIT proposals and publications, as requested Contribute to global alignment of Phase 3b\/4 clinical studies (and Phase I and II studies where applicable) planned by country (ies) or global Development team. 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. Regulatory Support Activities Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists, support \/ assist in the preparation of regulatory reports participate in advisory committees. Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific \/ Technical Expertise and continued development Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years). 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. Responsible for the scientific training of the clinical study team. Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses\/scientific symposia. Basic Qualifications Medical Doctor Speciality in Neurology, Internal Medicine or any other with established expertise in Headache and\/or pain management. Must be board eligible or certified in appropriate specialty\/subspecialty\u00a0or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. Foreign medical graduates 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 school that meets the requirements of the Liaison Committee on Medical Education (LCME). Additional Skills\/Preferences Knowledge of drug development process relevant to country\/region preferred Demonstrated ability to balance scientific priorities with business priorities\u00a0 Demonstrated strong communication,, interpersonal, teamwork, organizational and negotiation skills Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication ADDITIONAL PREFERENCES Professional association staff and leaders Disease advocates and lay organizations focused on relevant health issues 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

9 days 18 hours ago

Eli Lilly and Company


Senior Medical Advisor Neuro Pain Eli Lilly and Company - Indianapolis, IN, United States


Location: Indianapolis, IN

Company Profile:
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.