Lilly Clinical Research Physician - Diabetes Design Hub in Indianapolis, Indiana
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.
Clinical Research Physician - Diabetes Design Hub
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Design Hub (DH) seeks to deliver a core clinical design capability with tightly integrated cross-functional expertise to provide consistent, high quality designs to asset teams. The DH Clinical Research Physicians (CRPs) provide scientific, clinical, and therapeutic expertise and leadership.
Through application of scientific training, clinical expertise, and relevant experience, the Design Hub CRP plays a key role in the development of corporate/global clinical trials; while the Design Hub’s initial focus is on proof of concept and registration clinical studies, Design Hub CRPs may work on trials across early and/or late phases of development and commercialization of the product. Design Hub CRPs also participate in the review process for protocols and publications and as needed works with regulatory and other governmental agencies.
Design Hub CRPs will participate, at times, in activities largely led by Asset Team CRPs and CRSs (Clinical Research Scientists) such as outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The DH CRP must have deep understanding clinical study design and research in the following areas: Diabetes, Obesity & associated Complications.
She/He must also be aware of novel design and execution paradigms and be willing to interact and learn from different teams, including different therapeutic areas.
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
The primary responsibilities of the Diabetes Design Hub CRP are generally related to phase I to IV compounds. The core job responsibilities typically include those listed below as well as all other duties as assigned.
Clinical Planning, and Clinical Trial Protocols
Lead efforts to design/develop clinical study protocols aligned with the product lifecycle plan and clinical strategy to address key customer needs (patient, regulator, prescriber, and/or payer). The DH CRP will collaborate with the Diabetes Therapeutic Area Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and design of these protocols.
Provide clinical leadership in collaboration with other DH members in appropriate development of standardized/simplified processes, templates, and tools.
Provide clinical leadership and insight to DH activities, bringing systematic consideration of impact to execution speed/efficiency in the design of protocols and clinical trial packages.
Lead development of optimized design and execution elements in clinical plans that deliver high quality, cost efficient clinical development outcomes and provide expert consultation to Business Unit or Research teams in development of their Clinical Program plans. DH input will emphasize organizational learning, best practice application, and systematic consideration of design options.
Engage appropriately with the asset teams and some of their external activities in order to have good understanding of their patients, medical and payer communities, and business strategy.
Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.
Closely collaborate with asset teams and execution teams to understand the impact of design on speed to protocol approval and optimizing through standardized approaches. Work with other DH staff to analyze experience and improve approaches.
Clinical Research/Trial Packages, Execution and Support
Collaborate with clinical research staff in the design and conduct clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
Review risk profiles to ensure appropriate communication of risk to study subjects.
Participate in investigator identification and selection, in conjunction with Design Hub and clinical teams.
Support seamless transition of protocols from design to execution.
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.
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Participate in development of scientific data dissemination, and preparation of final reports and publications.
Scientific / Technical Expertise and Shared Learning
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.
Be aware of current trends and projections for clinical research, and practice, and access in the therapeutic area(s) relevant to the product.
Focus on organizational learning to identify best practices, delivering these as systemized standard approaches with goal to make program and protocol design faster and less expensive. This will require cross-TA sharing within the hub and structured efforts to understand and benefit from our repeated, ongoing experiences.
Ensure drug development shared learning amongst colleagues within and outside of the Design Hub.
Work closely with counterparts in other TAs to continue to evolve Lilly standards, tools and best practices across development.
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. US trained physicians must have achieved board eligibility or certification. Foreign medical graduates who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
Non-US 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
Board certification or eligibility within Diabetes, Obesity and Complications is strongly preferred.
Strong understanding of Diabetes, Obesity and Complications therapeutic areas – pathology, pathophysiology, unmet needs, and treatment standards.
Clinical research or pharmaceutical medicine experience in of at least five years and adequate to provide strong grounding in the drug development progress, clinical trial principles, and scientific decision-making. Ideally, this experience will have accrued in an industry or academic setting.
Expertise in one or more areas relevant to clinical trial design are strongly preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc.).
Clinical research experience within Diabetes, Obesity and Complications therapeutic areas is preferred.
Fluent in English; both written and verbal communications.
Interpersonal, organizational and negotiation skills.
Ability to influence others (both cross-functionally and within the function) to create a positive working environment.
Excellent teamwork skills.
Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.
Primary internal interactions
Director(s)-Clinical Operations, managers or project managers
Clinical planning, operations, CRPs/CRSs, other research staff
Scientific communication associates
Health outcomes research consultants/research scientists
Regulatory directors, scientists, and associates
Product directors, managers, and associates of the brand teams
Therapeutic area physicians, development CRP/CRSs, medical affairs CRP/CRSs, early phase physicians, and Sr. Director-Medical
Global Marketing director or manager
Corporate patient safety physician
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Regulatory agency personnel
Professional association staff and leaders
Disease advocates and lay organizations focused on relevant health issues
Formulary representatives (private and government)
For internal employees, if you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4.
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!