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This job is under medical department for Autoimmune(AI), a prospective critical therapeutic area of Lilly China. Lilly China will strongly enter AI area with innovative clinical development and new product launch (e.g. baricitinib) in coming years.
Core Job Responsibilities
The primary responsibility of the CRP is to provide expert medical expertise to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company. The CRP responsibility includes development the strategic medical plan for the compound, provide medical expertise for regulatory affairs and interactions with government agencies, providing medical guidance on the PRA plan, and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc.) The CRP is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3/4 studies (and phase I and Il studies where applicable), as well as non-clinical trial solutions/activities that are conducted in China. In addition, the CRP, if assigned, is responsible for global Development studies conducted in China. The core job responsibilities may include those listed below.
Business governance/customer interaction (pre and post launch)
Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
Develop medical strategies to support brand commercialization activities during the development of the local business plan.
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.
By offering scientific and creative Input, contribute to the development, review, and approval of promotional materials for the brand team.
Provide scientific training of sales representatives, and other function.
Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert.
Scientific Data Dissemination/Exchange
Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
Plan and set up medical symposia, advisory board meetings, and/or the facilitation of other meetings with health care professionals.
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
Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs Communicate local/regional research needs and collaborate with other regions and the global
Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
Clinical Research/Trial Execution
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials Collaborate with 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.
Review IIT proposals and publications, as requested Contribute to global alignment of Phase 3b/4 clinical studiesMonitor 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 Related 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, and communication and resolution of regulatory issues, including regulatory response, 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.
Attend, contribute and participate in medical congresses/scientific symposia.
Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget.
Collaborate proactively and productively with all alliance, business, and vendor partners.
Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness.
Model the leadership behaviors.
Be an ambassador of both patients and the Lilly Brand.
Medical Doctor or Doctor of rheumatology. 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.
Must have completed education and training at a medical school
Five to ten years of Clinical research or pharmaceutical medicine experience·
Knowledge of drug development process relevant to country/region preferred
Demonstrated ability to balance scientific priorities with business priorities·
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.