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Clinical Research Physician

Indianapolis, Indiana

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Req ID R-3965 Title Clinical Research Physician 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 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.

Medical Advisor-Global Medical Affairs

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. #WeAreLilly

Responsibilities

The Medical Affairs Clinical Research Physician (CRP) is an integral member of the US & Global medical affairs team, the product development team, and the brand team and focuses on 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 CRP will accomplish this through the application of scientific and medical training, clinical expertise, and relevant clinical experience. 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 I Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases.  

Business/ Customer 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.
  • Contribute to the development of medical strategies to support brand commercialization activities by working closely with the US & Global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and US & Global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.
  • Contribute as a scientific and medical 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.
  • By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
  • Become familiar with market archetypes and potential influence on the medical interventions for the product.
  • Understand and apply knowledge of customer insights to all customer-related activities.
  • Provide medical insight and training to patient support programs.
  • Participate in local or national trade associations, as appropriate.

Scientific Data Dissemination/Exchange 

  • Knowledge of and compliance with local laws and regulations, and US & 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 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.
  • 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.
  • 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 

  • 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
  • Communicate local/regional research needs and collaborate with other regions and the US & Global Development and Medical Affairs teams, Global Patient Outcomes/Real World Experience, 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
  • 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 commitment, timelines, grants, and governance review interactions).
  • 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.
  • 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

Basic Qualifications

  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty 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

Additional Skills/Preferences

  • 5+ years of oncology medical affairs experience including experience in oncology launches
  • Excellent understanding of in-house medical affairs function
  • Knowledge of drug development process relevant to country/region preferred
  • Fluent in English, verbal and written communication.
  • 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.

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-3965.

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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