Clinical Research Scientist
Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) 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 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 Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit 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 CRS 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
Core Job Responsibilities
The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical 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 PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local 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 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, if assigned by the Director-Medical and/or Business Unit Team Physician/Regional 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 (pre 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 Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.
- Contribute as a scientific and clinical 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 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.
- Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).
- Understand and apply knowledge of customer insights to all customer-related activities.
- Participate in local or national trade associations as appropriate
Scientific Data Dissemination/Exchange
Clinical Research/Trial Execution and Support
Regulatory Support Activities
Scientific I Technical Expertise and continued development
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 39,000 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 Basic Qualifications
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
- 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
Primary internal interactions include, but not limited to:
- Therapeutic area directors, managers, or project managers
- Product directors, managers, and associates of the brand
- Clinical research staff
- Scientific communication associates
- Medical information associates
- Medical liaisons
- Global patient outcomes research consultants/research scientists and health outcomes liaisons
- Regulatory directors, scientists, and associates
- Sales representatives
- Legal counsel
- Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical.
- Corporate or regional patient safety physician(s)
- Scientific and clinical experts, thought leaders
- Lilly clinical investigators
- Practicing physicians/prescribers
- Regulatory agency personnel
- Professional association staff and leaders
- Disease advocates and lay organizations focused on relevant health issues
- Formulary representatives (private and government)
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status