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. #WeAreLilly
As a member of the Oncology Early Phase Program, the clinical research scientist (CRS) will work within one or several early phase development teams to provide clinical and scientific expertise in support of early phase oncology drug development. The scientist will be an integral part of the drug-discovery process. They will work closely with other Lilly discovery scientists, the clinical development team, the global affiliates, and New Product Planning to implement the global drug development strategy. The scientist will interact with external consultants, opinion leaders, and worldwide regulatory agencies, and will be a contact for inquiries related to their specific compounds. You will be expected to provide clinical expertise as a peer and consultant to other oncology program teams, and may be involved in the clinical/scientific evaluation of external business development opportunities.
Specific Core Job Responsibilities include the following: Clinical planning activities, Clinical Research/Trial Execution and Support, Scientific Data Dissemination/Exchange, Regulatory Support Activities, Extensive biomarker examination within the clinical program and other general responsibilities
Provide expertise to drug-discovery teams involved in clinical candidate selection overseeing laboratory to clinic transition of oncology compounds.
Assist with target identification and validation efforts guided toward development of new oncology therapeutics.
Implement medical aspects of global strategy and clinical plans for various oncology compounds.
Review protocols for clinical trials.
Collaborate on the statistical analysis and preparation of clinical study reports.
Assist in the preparation of clinical trial results to corporate committees, regulatory agencies, and outside audiences.
Provide support for global regulatory reports.
Monitor safety reports and assist with implementation of appropriate pharmacovigilance actions, if necessary.
Monitor global scientific/medical literature
Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities
An advanced scientific/medical graduate degree strongly preferred such as PharmD, PhD, or MD
Minimum 5 years of relevant academic or industry experience
Clinical experience in the field of medical oncology and experience with the clinical trial process, particularly with oncology phase I and phase II (proof-of-concept) studies
Knowledge of drug development process
Preferred Fluent in English; both written and verbal communications
Interpersonal, organizational and negotiation skills
Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Excellent teamwork skills.
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