Lilly Sr Res Scientist-Clinical in Indianapolis,New York, United States
Through the application of scientific training and clinical training and expertise, the Development clinical research scientist participates in:
the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product;
the implementation of global clinical trials;
the reporting of adverse events as mandated by corporate patient safety;
the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts;
contacts with regulatory and other governmental agencies;
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;
various medical activities in support of demand realization.
In this role, you will serve as a scientific resource for study teams, departments, and others as needed.
- Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design. Contribute to business unit and 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
Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline. Provide protocol oversight and input into informed consent documents. Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Collaborate with clinical research staff in the reporting of local clinical trials (for example, grants, and governance review interactions). Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.Ensure 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. Review IIT proposals and publications, as requested by CRP or Director-Medical
Regulatory Support Activities
Participate in 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 and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective. Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
Strong preference for 2 years of experience in clinical development
Oncology experience / expertise is desired
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, 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.
Fluent in English, verbal and written communication
Primary internal interactions
Director(s)-Clinical Operations, managers or project managers
Clinical planning, operations, CRPs/Ss, other research staff
Scientific communication associates
Medical information associates
Global patient outcomes research consultants/research scientists and health outcome liaisons
Regulatory directors, scientists, and associates
Product directors, managers, and associates of the brand teams
Sales district managers and sales representatives
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.
- An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following:
3-5 years of clinical experience or
3-5 years of pharmaceutical experience
- Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following:
Clinical trial experience
Experience in areas relevant to drug discovery
Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
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.
State / Province:
Indiana, New York