Through application of scientific training, clinical expertise, and relevant experience, the Diabetes Business Unit US Medical Affairs clinical research physician (CRP) participates in: design and conduct of local clinical trials; development of local clinical, regulatory, and scientific data dissemination strategies; new product launches; and various commercialization activities. The CRP is an integral member of the US brand team for strategic planning, launch, and commercialization support. The US Medical Affairs team is part of a global medical affairs organization, so international interactions will be frequent. The CRP may also work closely with Lilly Diabetes global development teams on new product development activities over the entire spectrum from Phases 2-4.
The primary responsibilities of the Diabetes Business Unit US Medical Affairs CRP are generally related to late-phase and marketed compounds. The CRP is responsible for collaborating with local research staff in the planning, startup and conduct of phase 3b/4 studies that are conducted in US.
1. Clinical Planning
o Communicate and collaborate with Sr. Medical Director to ensure life cycle plans for drugs in
development address customer needs or communicate to global Development teams, Global
Health Outcomes (GHO), PRA, Therapeutic Area Program Phase, and Early Phase /EPM
/Translational Medicine teams.
o Communicate local/regional 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.
o Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
o 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.
2. Clinical Research/Trial Execution and Support
o Review and approve local informed consent documents to ensure appropriate communication of risk to study subjects.
o 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).
o 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.
o Participate in investigator identification and selection.
o 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.
o 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.
o 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.
o Review IIT proposals and publications.
o Contribute to global alignment of Phase 3b/4 clinical studies planned by country or global
o Understand and actively address the scientific information needs of all investigators and personnel.
o Monitor patient safety during the conduct of studies and conduct the appropriate tracking and
follow-up of adverse events.
3. Scientific Data Dissemination/Exchange
o 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.
o Understand and actively address the unsolicited scientific information needs of external health care professionals.
o Support the planning of symposia, advisory board meetings, and and/or the facilitation of other
meetings with health care professionals.
o Support medical information associates in preparation and review of medical letters and other
medical information materials.
o Support training of local medical personnel, including medical and outcome liaisons and health
o Prepare or review scientific information in response to customer questions or media requests.
o Provide follow-up to information requested by health care professionals as per global SOPs.
o Support data analysis and the development of slide sets and publications (abstracts, posters,
o Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national basis.
o Develop and maintain appropriate collaborations and relationships with relevant professional
o Support the design of customer research as medical expert.
o 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).
o Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
o Participate in reporting of clinical trial data in Clinical Trial Registry activities.
4. Regulatory Support Activites
o Participate in development and review of local labeling and labeling modifications in collaboration
with global Development, brand teams, regulatory, and legal.
o Provide medical expertise to regulatory scientists.
o 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,
o including regulatory response, from an affiliate/country perspective.
o Participate in advisory committees.
o Participate in risk management planning.
5. Business/ customer support (pre and post launch support)
o Understand the scientific information needs of all local/regional customers (payers, patients, health
o 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.
o 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.
o 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.
o Support business-to-business and business-to-government activities as medical expert.
o Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.
o Review, offer scientific and creative input, and approve promotional materials for brand team.
o Support training of sales representatives, and other medical representatives.
o Become familiar with market archetypes and potential influence on the medical interventions for the product.
o Participate in local or national trade associations as appropriate.
6. Scientific/Technical Expertise and Continued Development
o Be aware of current trends and projections for clinical practice and access in the therapeutic
area(s) relevant to the product.
o 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.
o Explore and take advantage of opportunities for extramural scientific experiences.
o Attend, contribute and participate in medical congresses/scientific symposia.
- MD or DO. Must be board eligible or certified in Endocrinology and Metabolism.
- Specific in depth experience with diabetes (clinical practice and/or clinical research).
- Clinical research or pharmaceutical medicine experience.
- Knowledge of drug development process relevant to US.
- 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
- Excellent teamwork skills.
- Travel is a regular part of this job and is primarily US-focused; occasional international travel may be
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- This position is based in Indianapolis.
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