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Medical Advisor-Medical Affairs-Diabetes

Indianapolis, Indiana

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Req ID R-11439 Title Medical Advisor-Medical Affairs-Diabetes City Indianapolis State / Province Indiana Country United States

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.

Clinical Research Physician (CRP) – Diabetes Business Unit 

Purpose: 

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Diabetes Business Unit - Medical Affairs Clinical Research Physician (CRP) 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 CRP 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 CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase / Clinical Pharmacology, and Translational Medicine team(s).   
 

The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed.  The Clinical Research Physician 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:  

The primary responsibility of the Diabetes Business Unit - Medical Affairs CRP is to provide expert medical 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 pricing, reimbursement and access(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 CRP is responsible for the planning, startup and conduct of phase 3b/4 Insulin studies (and phase I and II studies where applicable), as well as non clinical trial solutions/activities that are conducted in the global team in affiliates/countries as described in the clinical plan.With the expansion of the Lilly diabetes portfolio (including assets developed and marketed with the Lilly – Boehringer Ingelheim alliance),  this role will be responsible for leadership that allows appropriate scientific support for incretins family within the portfolio and across the spectrum of patients with diabetes. This includes, but is not limited to, design and execution of phase 4 studies and expansion of real-world evidence, observational data and patient reported outcomes to address the needs of the commercial organization  

Successful and relevant phase 4 programs must anticipate provider, patient, policy and payer questions years in advance of customer inquiries. This work will require cross-portfolio, patient-reported and observational studies aligned with therapeutic tailoring strategies. This requires in depth knowledge of diabetes, metabolism and related conditions (including risk factors and co-morbidities) and an in-depth understanding of global research, real world evidence, clinical and commercial needs and a full understanding of the current insulin needs and emerging diabetes portfolio. 

 

Business/ customer support (pre and post launch support) 

  • 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, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. 

  • Develop and maintain appropriate collaborations and relationships with relevant professional societies. 

  • Support the design of customer research as medical expert. 

  • Provide congress support (for example, 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 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  

  • Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. 

  • Participate 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 participate 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 IIT 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 team. 

  • Understand and actively address the scientific information needs of all investigators and personnel.  

  • Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. 

Regulatory Support Activities  

  • 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 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. 

  • Explore and take advantage of opportunities for extramural scientific experiences. 

  • Attend, contribute and participate in medical congresses/scientific symposia. 

General Responsibilities 

  • Be an ambassador of both patients and the Lilly Brand. 

Minimum Qualification Requirements:  

  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.

  • Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).  For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm

Preferences:

  • Minimum seven years of clinical research or pharmaceutical medicine experience   

  • Knowledge of drug development process relevant to country/region preferred 

  • Demonstrated ability to balance scientific priorities with business priorities   

  • 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.

 

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-11439.

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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