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Clinical Research Scientist - Oncology

Indianapolis, Indiana

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Req ID R-34509 Title Clinical Research Scientist - Oncology City Indianapolis State / Province Indiana Country United States Region Research

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 35,000 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.

Through application of scientific training, clinical expertise and relevant experience, the Verzenio Development Clinical Research Scientist (CRS) participates in:  the development, conduct and reporting of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the 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; partnering closely with investigation sites, working closely with internal partners including global, medical, commercial, and affiliate teams, and various medical activities in support of demand realization.

In addition, with input from the Clinical Research Physician (CRP) or Sr. Director-Medical, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective affiliate brand team(s), global Development team(s), Therapeutic Area Program Phase, Early Phase, and Translational Medicine team(s). The CRS is an integral member of the global brand team for strategic planning in the support of clinical development and launch activities as needed.  The CRS may also work closely with many cross functional partners in new product development activities over the entire spectrum of drug development and clinical trial phases.

The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidances (e.g. FDA, ICH, etc.), Good Clinical Practices (GCPs), company standards, CIA agreement, Lilly policies and procedures, and the Principles of Medical Research.

Core Job Responsibilities:

The primary responsibilities of the CRS are generally related to late-phase and marketed compounds. The CRS is responsible for collaborating with global research staff in the planning, startup and conduct of phase 2, phase 3, and 3b/4 studies as needed.  In addition, the CRS, if assigned by the CRP or Sr. Director-Medical, is responsible for affiliate support of global Development studies conducted in the U.S.

The core job responsibilities include those listed below as well as other duties as assigned.

Clinical Planning

  • Communicate and collaborate with the global commercial and medical affairs, global health outcomes (GPORWE), Pricing Reimbursement, and Access, TA Program Phase, and Early Phase /EPM /Translational Medicine teams in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
  • Communicate global brand research priorities and collaborate with the US and IBU teams, GPORWE, and Global PRA teams to ensure Phase 2, 3, 3b, and 4 (as needed) clinical programs meet the needs of customers. Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
  • Represent the research priorities and plans of the brand to the business unit leadership in the development of clinical strategies, development plans and study protocol design.

Clinical Research/Trial Execution and Support

  • Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline
  • Provide protocol oversight and input into ICDs
  • Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures
  • Collaborate with clinical research staff in the design, conduct and reporting of clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions)
  • Review and collaborates with CRP on the approval of risk profiles to ensure to ensure appropriate communication of risk to study subjects
  • Participate in investigator identification and selection, in conjunction with clinical teams
  • Ensure that operational 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 planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel
  • Serve as resource to clinical research staff / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study
  • Understand and actively address the scientific information needs of all investigators and personnel
  • Review IIT proposals and publications, as requested by CRP or Sr. Director-Medical


Scientific Data Dissemination/Exchange

  • Collaborate closely with medical affairs in various activities in the communication and dissemination of clinical trial data
  • 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 address the unsolicited scientific information needs of external health care professionals according to guidelines above
  • Participate in reporting of clinical trial data in Clinical Trial Registry activities
  • Support the planning of symposia, advisory board meetings, and other meetings with health care professionals
  • Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts)
  • Develop and maintain appropriate collaborations and relationships with relevant professional societies
  • 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)
  • Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications
  • Prepare or review scientific information in response to customer questions, investor, or media requests
  • Provide follow-up to information requested by health care professionals as per global policies


Regulatory Support Activities

  • Participate in various submission related activities for NME or NILEX as needed
  • Participate in development and review of label changes and labeling modifications in collaboration with medical, brand teams, regulatory, and legal
  • Provide 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 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)
  • Business/ customer support (pre and post launch support)
  • Work closely with investigator sites and their staff to ensure the successful execution of studies
  • Understand the scientific information needs of external customers (payers, patients, health care providers)
  • Contribute to the development of medical strategies to support development and brand commercialization activities by working closely with brand teams, global PRA and GPORWE, clinical management or personnel and other cross-functional management during the development of the business plan
  • Provide data and support to help answer customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new analyses and trials as needed
  • Provide support as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to communicate and defend the product value
  • Engage externally with investigators, thought leaders, research organizations, and/ or industry groups
  • Scientific / Technical Expertise and continued development
  • 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
  • Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product
  • Explore and take advantage of opportunities for extramural scientific experiences
  • Attend and participate in scientific symposia, as well as administrative/business workshops and training

General Responsibilities

  • Support the management team, including the CRP or Sr. Director-Medical, in preparation and administration of the clinical development medical budget
  • Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers
  • Actively participate in recruitment, diversity, and retention efforts as applicable. Participate in committees, process improvement initiatives and task forces as requested by business unit management and be an exemplar of Team Lilly

Minimum Requirements:

  • Advanced medical related graduate degree, such as: PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field.

OR ​

  • BS degree in a health-related or scientific field with 5+ years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.

OR

  • 3-5 years of clinical experience, or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience.

Preferences:

  • Knowledge of drug development process preferred
  • Prior experience of working in oncology / breast oncology (academia /industry) is desirable
  • Interpersonal, organizational and negotiation skills
  • Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
  • Excellent teamwork skills

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.


As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

#WeAreLilly

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-34509.

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.

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