Principle Research Scientist-Closed Loop

The purpose of this role is to lead the launch preparation of Lilly Hybrid Closed Loop system as well as to lead the medical affairs work on the system after its launch in US Medical Affairs department.

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 improve 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 leaders with vision; 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 this Business Unit- Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of Hybrid Closed loop solution:

Business/ customer support (pre and post launch support)

• Understand and anticipate the scientific information needs of all local/regional customers
• Actively address customer 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.
• 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.
• 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.

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, and actively participate in advisory board meetings, scientific exchange meetings, and 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.
• Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community.
• Develop collaborations and relationships with relevant professional societies.
• Support the design of market research as medical expert.
• Provide congress support
• Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.

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.
• Communicate local/regional research needs and collaborate with other regions and teams to ensure clinical programs meet the needs of local/regional customers.
• 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 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.
• Collaborate in the development of protocols and data collection requirements.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• 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 proposals and publications, as requested
• Contribute to global alignment of clinical studies planned by Development and Medical Affairs teams.
• Understand and actively address the scientific information needs of all investigators and personnel

Regulatory Support Activities

Scientific I Technical Expertise and continued development
General Responsibilities

Company Overview

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

• 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
  
  1. 3-5 years of clinical experience or
  2. 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 CRS role

• Clear evidence and documentation of candidate's 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 c medical, scientific or clinical information)
• Candidate's selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership

Additional Information

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

Additional Skills/Preferences

• 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 build a positive working environment.
• Medical or Commercial experience in device business
• Fluent in English, verbal and written communication