Innovation readiness Clinical Research Scientist

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the International Business Unit- Medical Affairs Clinical Research Scientist (CRS) or Clinical Research Physician (CRP) is an integral member of the medical affairs, development or a business unit brand team for strategic planning in the support of launch and commercialization activities to meet patients' needs and ultimately enhance the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs) and payers. The CRS OR CRP may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase/ Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; 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. In addition, with input from the Director-Medical and Business Unit Team Scientist/Regional Medical Leader, the CRS OR 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 Scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibility of the International Business Unit - Medical Affairs - Neuroscience Therapeutic Area CRS OR CRP is to provide expert scientific support to all aspects of the international business in the Neuroscience therapeutic area, to ultimately enhance the customers' experience in interacting with the company. This includes international marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical/scientific support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for pricing, reimbursement and access(PRA) (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in international scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late phase and marketed compounds, but can also include early phase trials (for example, phase I and II trials). The CRS OR CRP is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS OR CRP, if assigned by the international Medical Leader, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Business/ customer support (before and post launch support)

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.

Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Value Outcomes and Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the international business plan.

Contribute as a scientific 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 scientific expert.

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.

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.

Understand and apply knowledge of customer insights to all customer-related activities.

Provide medical insight and training to patient support programs (for example, Alzheimer’s disease caregivers Nurse Educators Service).

Participate in local or national trade associations, as appropriate.

Scientific Data Dissemination/Exchange

Knowledge of and compliance with international 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 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.

Provide follow-up to information requested by health care professionals as per global SOPs.

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 an international, and possibly local, national, regional basis.

Develop and maintain appropriate collaborations and relationships with relevant professional societies.

Support the design of customer research as medical expert.

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.

Participate in reporting of clinical trial data in Clinical Trial Registry activities.

Clinical Planning

Communicate and collaborate with Director-Medical and Business Unit Team Scientist/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Scientist/Regional Medical Leader, as needed, global Medical Affairs and Development teams, Global Value Evidence and Outcomes, PRA, Therapeutic Area Program Phase, and Early Phase /Translational Medicine teams.

Communicate local/regional research needs and collaborate with other regions and the global development and Medical Affairs teams, Global Patient Outcomes/Real World Experience, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).

Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

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 and Support

Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.

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 other Clinical Research Scientists, 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 or collaborative studies 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 scientific/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/country 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 I 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.

General Responsibilities

To ensure healthcare systems innovation readiness internationally through process simplification and implementation in multiple healthcare systems of different Dx tools in AD and related disorders (Working on elevating blood markers of AD as validated diagnostic tools where approved).

Present at congresses on these new processes and work with Intl KOLs to educate and train on AD & related disorders Dx markers as they evolve over time

Work in partnership with Dx team to connect with Dx companies (e.g. GE Healthcare, Siemens, Fujirebio, Roche Dx) and CMOs to promote AD Dx marker optimal use (facilitating innovation) and deployment.

Collaborate with medical teams OUS and other internal stakeholders including the clinical imaging scientists (CIS) and medical science liaisons

Synthesize complex data and effectively communicate meaningful clinical insights to the cross functional team

Supervise IIR proposal review in IBU and liaise with global development team for endorsement of prioritized projects

Interact with VEO group in a co creation partnership of key RWE studies OUS. 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.

Support training of sales representatives, and other medical representatives.

Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Value Outcomes and Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the international business plan.

Be an ambassador of both patients and the Lilly Brand.

Launch Support

Key skills/requirements:

Needs deep knowledge of molecule, AD & related disorders Dx tools and existing development plan

Will need to

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