Lilly Clinical Research Physician-Design Hub in Indianapolis, Indiana
Clinical Research Physicians are key scientific leaders within the Design Hub (DH). The DH seeks to deliver a core clinical design capability with tightly integrated cross-functional expertise to provide consistent, high quality designs to asset teams. DH CRPs provide scientific, clinical, and therapeutic expertise and leadership. The DH will enable more frequent/repeated individual involvement than alternate constructs in Program/Trial design, and learning/improvement from these repeated cycles and cross-therapeutic and cross-functional sharing of knowledge are key objectives of the hub.
Through a partnering of scientific training, clinical expertise, and relevant experience, the Design Hub Clinical Research Physician (CRP) plays a key role developing corporate/global clinical trials. Design Hub CRPs may work on trials across early and/or late phases of development and commercialization of the product. Design Hub CRP also participate in the review process for protocols and publications, and as needed work with regulatory and other governmental agencies. Design Hub CRPs will contribute, at times, in activities largely led by Asset Team CRPs and CRSs. This involves 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 Clinical Research Physician must have deep understanding of Oncology and clinical study design and research. You must also be aware of novel design and execution paradigms, be willing to interact and learn from different teams, including different therapeutic areas.
The primary responsibilities of the Oncology Design Hub CRP are generally related to Oncology 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 Oncology Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in developing and crafting of these protocols. Protocol approval is by both DH and Asset Team Senior Director/Senior Medical Director. Provide clinical influence in collaboration with other 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. Offer expert consultation to Business Unit or Research teams in development of their Clinical Program plans. DH input will emphasize organizational learning, standard methodology application, and systematic consideration of design options.
Engage appropriately with the asset teams and some of their external activities in order to have deep understanding of their patients, medical and payer communities, and business strategy.
Contribute 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. Work over time with other DH staff to analyze experience and improve approaches.
Clinical Research/Trial Packages, Execution and Support
Collaborate with clinical research staff on design and conduct clinical trials (e.g., sample size, patient dedication, timelines, grants, and governance review interactions).
Review risk profiles to ensure appropriate communication of risk to study subjects.
Contribute to investigator identification and selection, in conjunction with Design Hub and clinical teams.
Support flawless 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 developing 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.
Analyze 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 standard methodologies, delivering these as systemized standard approaches with ultimate 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 DH
Work closely with counterparts in other TAs to continue to evolve Lilly standards, tools and standard methodologies across development.
Actively participate in subject recruitment, diversity, and retention efforts.
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
Board certification or eligibility within Oncology is strongly preferred.
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 Oncology therapeutic area 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) in order to craft a positive working environment.
Excellent teamwork skills.
Willing to relocate to Indianapolis.
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/Ss, 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/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Director-Medicals
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
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
Medical Advisor, Clinical Development Design Hub - Oncology
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)
Strong understanding of Oncology therapeutic area – pathology, pathophysiology, unmet needs, and treatment standards.
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