Through application of scientific training, clinical expertise, and relevant experience, the U.S. Oncology Business Unit 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 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; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director or Sr. Director-Medical, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective affiliate brand team(s), global Development team(s), Therapeutic Area Program Phase, Early Phase / Exploratory Program Medicine (EPM), and Translational Medicine team(s). 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, Therapeutic Area 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 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, CIA agreement, Lilly policies and procedures, and the Principles of Medical Research.
The primary responsibilities of the U.S. Oncology Business Unit Medical Affairs Clinical Research Physician (CRP) are generally related to late-phase and marketed compounds. The CRP is responsible for collaborating with local and global research staff in the planning, startup and conduct of phase 3b/4 studies that are conducted in the U.S. In addition, the CRP, if assigned by the Director or Sr. Director-Medical, is responsible for affiliate support of global Development studies conducted in the U.S.
Clinical Research/Trial Execution and Support
- Communicate and collaborate with Director or Sr. Director-Medical to ensure life cycle plans for drugs in development address affiliate customer needs and/or communicate and collaborate with other areas as delegated by Director or Sr. Director-Medical to global Development, Global Health Outcomes (GHO), PRA, TA Program Phase, and Early Phase /EPM /Translational Medicine teams.
- Communicate local research needs and collaborate with other regions and the global Development team, 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.
Scientific Data Dissemination/Exchange
- Review and approve local informed consent documents to ensure appropriate communication of risk to study subjects.
- 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).
- 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 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 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 by Director or Sr. Director-Medical.
- Contribute to global alignment of Phase 3b/4 clinical studies planned by U.S. with global Development.
- 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
- 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 according to guidelines above.
- 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
- Provide follow-up to information requested by health care professionals as per local SOPs.
- 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 on a national and possibly international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Support the design of customer research as medical expert.
- 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.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Business/ customer support (pre and post launch support)
- Participate in development and review of local labeling and labeling modifications in collaboration with GBD and 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 global Development team(s), business unit, local area, and Global Patient Safety (GPS).
Scientific / Technical Expertise and continued development
- 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 brand teams, global PRA and HO, clinical management or personnel and other cross-functional management during the development of the local business plan.
- 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, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
- Review, offer scientific and creative support for, and approve promotional materials for brand team.
- Support training of sales representatives, other employees, and other representatives.
- Become familiar with market archetypes and potential influence on the medical interventions for the product.
- Participate in PhRMA or other local or national trade associations.
- Be 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
- Explore and take advantage of opportunities for extramural scientific experiences
- Attend and participate in medical congresses/scientific symposia.
- Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in Oncology/Hematology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification.
- 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). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
- Clinical research or pharmaceutical medicine experience
- Knowledge of drug development process relevant to U.S.
- Experience in the development of biologic agents
- Experience in Gastrointestinal Cancer therapy and new drug development
- Excellent English communication (written and verbal), 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.
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:
- Position located in Indianapolis, IN
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
Awards and Recognition
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