Lilly Research Advisor-Clinical in New York, New York
Cancer immunotherapy, also known as Immuno-oncology, is a rapidly evolving field. We have an expanding pipeline, and therefore need additional expertise to deliver the next wave of clinical studies.
Through the application of scientific and/or clinical training and expertise, the Development Clinical Research Scientist participates in the development, conduct and reporting of corporate clinical trials from first human dose to registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events; 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), 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 scientist serves as a scientific resource for study teams, departments, and others as needed.
The clinical research scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance’s (e.g. FDA, ICH, CPMP), 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
Assist Lilly scientists with target identification and validation efforts guided toward development of new oncology therapeutics.
Provide expertise to drug-discovery teams involved in clinical candidate selection overseeing laboratory to clinic transition of oncology compounds.
Develop and implement medical aspects of global strategy and clinical plans for various oncology compounds.
Interact with consultants, clinical pharmacologists, clinical investigators, and affiliate CRPs to plan, initiate, and conduct global clinical trials.
Develop and/or review clinical trial protocols and serve as medical lead for trial conduct.
Collaborate on the statistical analysis and preparation of clinical study reports.
Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and outside audiences, and publish results of research projects.
Provide support for global regulatory reports.
Monitor safety reports and implement appropriate pharmacovigilance actions, if necessary.
Establish and maintain contact with external experts and opinion leaders.
Explore and pursue opportunities for extramural scientific relations.
Attend and participate in scientific symposia as well as administrative and business workshops.
Monitor global scientific/medical literature.
Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities
Immunology experience strongly preferred
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
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.
Clinical Research Advisor, Immuno-oncology - New York
- An advanced scientific/medical graduate degree strongly preferred such as PharmD, PhD, or MD and the following
2-5 years of oncology experience and
2-5 years of pharmaceutical experience (including clinical development and/or 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.
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