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.

PURPOSE OF THE JOB

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. The CRS is responsible for the Oncology therapeutic area.

Core Job Responsibilities

The primary responsibility of the 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.

• 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
• Contribute to the development of medical strategies to support brand commercialization activities
• Contribute as scientific and clinical expertise to activities and deliverables of the PRA organization
• Support business-to-business and business-to-government activities as a 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 a patient advocate, as well as a medical expert.
• 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

• Knowledge of and compliance with local laws and regulations
• Understand and actively address the unsolicited scientific information needs HCPs
• Support the planning of symposia and meetings with HCPs
• Review of materials
• Support training of local medical personnel, including medical liaisons and health outcomes staff.
• Prepare or review scientific information
• Support data analysis and the development of slide sets
• Establish and maintain appropriate collaborations and relationships with HCPs
• Support the design of customer research
• Provide congress support
• 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 Physician/Regional Medical Leader
• Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams
• 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

Clinical Research/Trial Execution and Support

• Review and approve local informed consent documents and risk profiles
• Collaborate with clinical research staff
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Assist in the planning process and participate in study start-up meetings
• Serve as a resource to clinical research site monitors, investigators, and ethical review boards
• Review IIT proposals and publications
• Understand and actively address the scientific information needs of all investigators and personnel.
• Monitor patient safety

Regulatory Support Activities

• Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal.
• Support / assist in the preparation of regulatory requirements
• Participate in advisory committees.
• Participate in risk management planning

Launch Readiness Planning

• Insights, local positioning, brand planning, Scientific Story, etc.
• Collaborate with global brand development teams, Business Unit Team Physician/Regional Medical leader, and local cross-functional team members for launch preparation.
• Local Commercialization activities
• Responsible for launch readiness capability, partner with cross-functional teams
• Responsible to lead and drive to completion Medical Affairs launch readiness activities required for a successful launch of a product.

JOB REQUIREMENTS

• An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, Ph.D., MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following 3-5 years of clinical experience or 3-5 years of pharmaceutical experience (2 of which is in clinical development)

OR

• Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following
• 1 Clinical trial experience
• 2 Experience in areas relevant to drug discovery
• 3 Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)

If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a Advisor- CRS role

• Clear evidence and documentation of the candidate’s direct role and contribution to medical content. This should include evidence of the candidate as the medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific, or clinical information)
• Candidate’s selection for Advisor- CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
• 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

OTHER INFORMATION

Primary internal interactions include, but are not limited to:

• Therapeutic area directors, managers, or project managers
• Product directors, managers, and associates of the brand
• Clinical research staff
• Statisticians
• 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)

External Contacts

• 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)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

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