Senior Research Scientist-Clinical
Location: Indianapolis Indiana
Description: Eli Lilly is looking of Senior Research Scientist-Clinical right now, this career will be placed in Indiana. Detailed specification about this career opportunity please give attention to these descriptions. Leading/Purpose/Location:
Through application of scientific training, clinical expertise and relevant experience, the Diabetes Business Unit U.S. Medical Affairs Clinical Research Scientist (CRS) participates in: the development, conduct and reporting of local clinical trials in support of registration and commercialization of the product; the implementation of clinical trials conducted in the U.S.; 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, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and strategy for the product; and various medical activities in support of demand realization. In addition, with input from a CRP or the Medical Director, the CRS is responsible for assuring that his/her activities are aligned with the strategic priorities of the respective affiliate brand teams(s), global development team(s), Therapeutic Area Program Phase, Early Phase/Exploratory Program Medicine (EPM), and Translational Medicine team(s). The CRS is an integral member of an affiliate brand team for strategic planning in the support of launch and commercialization activities. The CRS may also work closely with other teams in new product development activities over the entire spectrum of drug development and clinical trial phases. The Clinical Research Scientist must be aware of, and ensure, that all their activities are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research.
Responsibility/Key Objectives/Deliverables:
The primary responsibilities of the U.S. Medical Affairs CRS are generally related to late-phase and marketed compounds. The CRS is responsible for collaborating with local research staff in the planning, start-up and conduct of phase 3b/4 studies conducted in the US. In addition, the CRS is may be assigned responsibility for affiliate support of global Development studies conducted in the US.
Clinical Planning
- Collaborate with the global Diabetes Business Unit, Global Health Outcomes (GHO), PRA, TA Program Phase and Early Phase/EPM, Translational Medicine teams in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, payer); the product lifecycle plan, clinical strategy, development plans and study protocol design.
- Contribute to business unit and global alignment of clinical strategy and clinical plans.
- Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
- Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
- Actively participates in Key Content Development.
- Provide protocol oversight and input into ICDs.
- Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
- Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
- Review and collaborates with the appropriate CRP on the approval of risk profiles to ensure to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with clinical teams.
- 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 clinical operations/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.
- Review IIT proposals and publications, as requested by CRP or medical director.
- 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 address the unsolicited scientific information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- 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 data analysis and the development of slide sets and publications (abstracts, posters, manuscripts).
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and health outcomes personnel.
- Provide congress support (e.g., 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 analysis, development of scientific data dissemination, and preparation of final reports and publications.
- Prepare or review scientific information in response to customer questions or media requests
- Provide follow-up information as requested by health care professionals as per local SOPs.
- Participate in development and review of label changes and labeling modifications in collaboration with local team/region, brand teams, regulatory and legal.
- 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 advisory committees.
- Participate in risk management planning along with affiliates and Global Patient Safety (GPS), global Development teams, business unit and local area.
- Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan.
- Review, offer scientific and creative support for, and approve promotional materials for brand team.
- Support training of sales representatives, Medical Liaisons and other employees.
- Understand the scientific information needs of all Affiliate customers (payers, patients, health care providers).
- Establish effective collaborations with marketing personnel to further corporate demand realization.
- Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
- Contribute as a 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.
- Support business-to-business and business-to-government activities as medical expert.
- Contribute actively on an ongoing basis to the strategic planning for the brand.
- Become familiar with market archetypes and potential influence on the medical interventions for 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.
- 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.
- Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product.
- Explore and take advantage of opportunities for extramural scientific experiences
- Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
- Advanced medical related graduate degree, such as: PharmD, PhD with 1-3 years
- MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 7 plus
- Demonstrated at least 2 years of clinical diabetes experience.
- 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
- Excellent teamwork skills.
- Position is located at Lilly in Indianapolis, IN.
- Willing to engage in domestic and international travel to the degree appropriate to support
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
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Eli Lilly.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Wed, 01 Aug 2012 07:23:44 GMT
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