Lilly Clinical Research Physician-Immunology in San Diego, California
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.
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.
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Immunology Clinical Research Physician (CRP) participates in the development, conduct, and reporting of clinical trials in support of molecules in early phase development in Immunology. The CRP serves as a scientific and medical resource for study teams, departments, and others as needed.
The CRP must be aware of and ensure that all activities of the medical 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 medical vision. Primary responsibilities are generally related to early-phase compounds.
Collaborate with new product planning, the business unit, discovery, statistics, and Exploratory Medicine and Pharmacology (EMP) and contribute to the development of asset profiles that addresses unmet medical needs and key customer needs (patient, provider, and payer)
Contribute to the design, conduct and interpretation of clinical trials to generate the data necessary to test the clinical hypotheses in the asset profile.
Collaborate with other scientists (e.g. PK/PD, statistics, research, ADME, EMP) to integrate study development
Contribute to business unit and global alignment of clinical strategy and clinical plans, as needed.
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule(s)
Clinical Research/Trial Execution and Support
Design, contribute and provide medical input into the scientific content of clinical documents such as protocols, investigator brochures, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline.
Review and approve risk profiles and informed consent documents to ensure to ensure appropriate communication of risk to study subjects.
Participate in investigator identification and selection, in conjunction with broader clinical teams.
Provide oversight ensuring that 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 Good Clinical Practices (GCPs) and local laws and requirements.
Assist in 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 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 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.
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.
Understand and actively address the unsolicited scientific information needs of external health care professionals.
Support the planning and execution of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.
Support training of local medical personnel.
Prepare or review scientific information in response to customer questions or media requests.
Provide follow-up to information requested by health care professionals.
Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts).
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Support the design of customer research as medical expert.
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
Participate in reporting of clinical trial data in Clinical Trial Registry activities
Regulatory Support Activities
Partner with regulatory colleagues to support the preparation of regulatory documents and reports
Provide medical expertise to regulatory scientists.
Participate in risk management planning
Contribute as a scientific and medical expert to activities and deliverables of the PRA organization.
Prior regulatory interactions and familiarity with pharmaceutical clinical development processes/terminology strongly preferred.
Clinical research or pharmaceutical medicine experience in Rheumatology, Dermatology, Gastroenterology, Allergy/Immunology, Neurology (especially multiple sclerosis) or related sub-specialty is strongly preferred.
Strong knowledge of basic immunology with basic immunology research experience preferred.
Knowledge of drug development process relevant to US and other countries, including EU and Japan.
Excellent English communication (written and verbal), interpersonal, 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
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 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
- Minimum of 2 years of clinical or academic research or pharmaceutical medicine experience
Travel Percentage: 10-25%
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!