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.

Clinical Research Scientist – Medical Affairs Dermatology Portfolio

Preference for location is Indianapolis-based; however, remote and OUS applications may be considered.

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 future 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 I 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 their 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 key 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 their activities are clearly positioned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I 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.

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. Collaborating with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibility of the Business Unit- 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 (take part 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 speaking publicly 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 speaking publicly at conferences, advisory boards, etc., and monitoring 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 in charge of 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.
Play a part in 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.
Actively confer on an ongoing basis the strategic planning for currently marketed brands.
By offering scientific and creative input, add 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 their medical knowledge. Become a 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.
Partake in local or national trade associations as appropriate.

Scientific Data Dissemination/Exchange

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.
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, leading authorities, professional societies, and the general medical community on a local, national, regional, and possibly international basis.
Support the design of customer research as a medical leader.
Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet key influencers and partake in customer events).
Share in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
Take part in the 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 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 Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/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 Evidence, 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 dedication, timelines, grants, and governance review interactions).
Collaborate with clinical research staff, regional clinical operations staff, statisticians, global outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.
Play a part 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 engage 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 lIT 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 and Medical Affairs teams.
Understand and actively address the scientific information needs of all investigators and personnel.
Supervise patient safety during studies and conduct the appropriate tracking and follow-up of adverse events, in agreement with corporate patient safety policies and procedures.

Regulatory Support Activities

Join 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.

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 pertinent to the product.
Responsible for the scientific training of the clinical study team.
Acts as scientific consultant and protocol expert for the members and others in medical.
Explore and take advantage of opportunities for extramural scientific experiences.
Attend and contribute in medical congresses/scientific symposia.

General Responsibilities

Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget.
Actively set and meet individual professional development goals and share in the development of others by being an active mentor and providing feedback to teammates and direct reports as applicable.
Collaborate proactively and efficiently with all alliance, business, and vendor partners.
Take part in active coaching by providing prompt and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team efficiency and cohesiveness.
As applicable, works closely with direct reports on performance management plans (objectives), development plans, and documentation of their expertise. Keeps these documents and plans up to date. Meets regularly with each direct report to coach, mentor, evaluate performance, evaluate training and development needs, and supervise career development goals. Improves each individual direct reports career potential, and the value each person brings to the organization.
Actively play a part in recruitment, diversity, and retention and hiring efforts as applicable.
Get involved with committees, Six Sigma initiatives and task forces as requested by business unit/corporate management.
Model the leadership behaviors.
Be an ambassador of both patients and the Lilly Brand.

Minimum Qualification Requirements:

An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following:
at least 10-15 years of clinical experience OR 10-15 years of pharmaceutical experience (preferably in Medical Affairs)

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:

-Clinical trial experience: (Experience in areas relevant to drug discovery 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 CRS role

Clear evidence and documentation of candidates direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
Candidates selection for 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/Additional Preferences:

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
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)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$142,500 - $228,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Eli Lilly