Clinical Research Physician Immunology

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 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Organization 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 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.

Responsibilities:

As Clinical Research Physician (CRP), you will provide medical and scientific leadership to the business and/or therapeutic area. The CRP also provides scientific expertise and consultative support to product teams, internal Lilly partners, external organizations, regulatory agencies and external partners on medical and scientific issues. This role will include medical monitoring for one or more large, multicenter, multinational trials, as well as authoring of regulatory documents.

You will act as a scientific and medical resource for study teams, departments, and others as needed. The CRP must be aware of novel ideas, be willing to interact and learn from diverse teams. The CRP must also be mindful of and ensure that all activities of the team are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the business area’s vision.

We are looking for intellectually curious people to join our science and clinical team. You will be a dynamic innovator and problem solver whose research can improve the lives of millions. We offer outstanding opportunities to capitalize on the groundbreaking spirit that is a part of our 140 year heritage. Although we have enjoyed many successes, our greatest legacy is the millions of lives that are impacted by our continued focus and drive.

Specific responsibilities may include but are not limited to:

Clinical Planning:

• Contribute to the global alignment of clinical strategy and clinical plans
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.

Clinical Research/Trial Execution and Support:

• Plan, collaborate on and review scientific content of clinical documents such as clinical trial protocols, clinical study reports, and submissions (for example, annual reports) according to the agreed-upon project timeline.
• Provide oversight and input into informed consent documents.
• 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).
• Review and approve risk profiles to ensure appropriate communication of risk to study participants.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that the operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with GCP and local laws and requirements.
• Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Serve as a resource to clinical operations personnel/ clinical research monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of the study.
• 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.
• Participate in the Publication Steering Committee (PSC), and the DRIVE meetings and review publications, as requested.

Scientific Data Dissemination/Exchange:

• Knowledge of and compliance with local laws, regulations, global policies and procedures with respect to data dissemination and interactions with external healthcare professionals.
• Understand and actively address the unsolicited scientific information needs of external healthcare professionals according to the guidelines above.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.
• Knowledge and understanding of the medical data generation and dissemination strategies of the portfolio.
• Support medical information associates in the preparation and review of medical letters and other medical information materials.
• Support the planning of symposia, advisory board meetings, and other meetings with healthcare professionals, if needed.
• Prepare or review scientific information in response to customer questions or media requests.
• Provide telephone follow-up or specific written information requested by healthcare professionals as per global standard operating procedures.
• 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 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 a medical expert.
• Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons, and global patient outcomes personnel.
• Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

Regulatory Support Activities:

• Participate in the development and review of label changes and labeling modifications in
• collaboration with affiliates, brand teams, regulatory, and legal.
• Provide medical expertise to regulatory scientists.
• Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual
• reports, preparation for FDA advisory committee hearings and label discussions, local
• registration efforts, and communication and resolution of regulatory issues, including
• regulatory responses, from a global perspective.
• Support/ assist in the preparation of internal communication materials and training activities
• for regulatory updates.
• Participate in advisory committees.
• Participate in risk management planning along with affiliates and Global Patient Safety.

Scientific /Technical Expertise and Continued Development:

• 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 practice and access in the therapeutic area(s) relevant to the product.
• Responsible for the scientific training of the clinical study team.
• Act as scientific consultant and protocol expert for clinical study team members and others.

General Responsibilities:

• Support the management team, in the preparation and administration of the budget.
• Actively set and meet individual professional development goals and contribute to the development of others.
• Actively participate in recruitment, diversity, and retention efforts.
• Collaborate proactively and productively with all alliance, business, and vendor partners.
• Participate in active coaching by providing timely and constructive feedback to co-workers, and others on the medical team, in the spirit of development, increased team effectiveness, and cohesiveness.
• Participate in committees, process improvement initiatives, and task forces as requested by local/corporate management.
• Ensure that at all times is adequately qualified and trained in the tasks required to perform.
• Includes accountability and compliance for maintaining a current curriculum training map for self.
• Model leadership behaviors.
• Be an ambassador of both patients and the Lilly Brand.

Basic Requirements:

Medical Doctor or Doctor of Osteopathy

• Physicians must have completed education and training at a medical school that meets the requirements of the US Liaison Committee on Medical Education (LCME) or an equivalent non-US committee.
• US-trained physicians (Medical Doctor or Doctor of Osteopathy) must have achieved board eligibility or certification in Immunology.
• Non-US trained physicians must have specialist training in Immunology or associated areas which include but are not limited to Gastroenterology, Dermatology, Rheumatology or Internal Medicine.

Additional Skills/Preferences:

• Clinical research or pharmaceutical medicine experience preferred, including experience with medical monitoring and/or regulatory submissions
• 5 years of work experience in Immunology
• Minimum of 5 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process, including some pediatric research and drug development.
• Fluent in English, written and verbal communications
• Comfortable with working with electronic data capture, case report forms, medical listings, Spotfire or other medical data visualization, and with interpretation of clinical trial efficacy and safety data
• Expertise in one or more areas relevant to clinical trials are strongly preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc.)
• Demonstrated success in implementing projects
• Publication record
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team
• Strong administrative and leadership skills
• Demonstrated knowledge of the drug development process
• Demonstrated strong communication, interpersonal, organizational, teamwork, and negotiation skills
• Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Fluent in English, both written and verbal communications.

Additional Information:

Location: US based. Must be able to work EST standard business hours with hybrid team headquartered in Indianapolis

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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