Clinical Research Physician-Immunology-Design Hub

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Responsibilities
Are you seeking a career that makes a difference in the world? We are pursuing a new Clinical Research Physician on our Immunology Team who has deep understanding of Immunology and clinical study design and research. Clinical Research Physicians are key scientific leaders within our Design Hub. The Design Hub seeks to deliver a core clinical design capability with tightly integrated cross-functional expertise to provide consistent, high quality designs to asset teams.

As a Clinical Research Physician (CRP) in our Design Hub, you will play a key role in the development of global clinical trials by providing scientific, clinical, and therapeutic expertise and leadership. While the Design Hub's initial focus is on proof of concept and registration clinical studies, you may work on trials across early and/or late phases of development and commercialization of the product. You may also participate in the review process for protocols and publications, and as needed, work with regulatory and other governmental agencies. There will also be opportunities for you to join in activities such as outreach medical activities aimed at the external clinical customer community, the formation and implementation of the global strategy for the product, and various medical activities in support of demand realization.

Sound interesting to you? Are you ready to bring your skills and talents to Lilly? Read on to find out more about the CRP responsibilities and how you can join Team Lilly.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).
• Cooperate with the BioMedicines Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and design of the protocols.
• Partner with the Asset Team Senior Director/Senior Medical Director to approve protocols.
• Provide clinical leadership and insight to Design Hub 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 teams in development of their clinical program plans.
• Closely collaborate with the asset teams and their external activities to maintain a 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.

Clinical Research/Trial Packages, Execution and Support

• Collaborate with clinical research staff with the design and conduct of 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.
• Support transition of protocols from design to execution.

Scientific Data Dissemination/Exchange

• Provide knowledge of and compliance with local laws and regulations and global policies and procedures with respect to data dissemination and interactions with external health care professionals.
• Establish and maintain appropriate collaborations and relationships with external authorities, professional societies, and the general medical community.
• Participate in developing scientific data and preparation of final reports and publications.

Scientific / Technical Expertise and Shared Learning

• Critically read and evaluate medical literature. Know the status and data from competitive products. Keep updated with medical and other scientific developments.
• Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s).
• 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.
• Work closely with counterparts in other TAs to continue to evolve Lilly standards, tools and processes across development.

Other Responsibilities

• Actively participate in subject recruitment, diversity, and retention efforts

48195BR

Basic Qualifications

• 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 who are not U.S. board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
• At least 5 years of clinical research and/or pharmaceutical medicine experience. Ideally this experience will have accrued in an industry or academic setting.
• 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).

Additional Skills/Preferences

• Deep understanding and clinical research experience of immunology therapeutic area - pathology, pathophysiology, unmet needs, and treatment standards. Board certification or eligibility within immunology 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.).
• Fluent in English; both written and verbal communications
• Social, organizational, and negotiation skills
• Ability to influence others (both cross-functionally and within the function) to create a positive working environment.
• 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.

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