Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.
We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.
Director, Regulatory, CDx
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.
The Manager Regulatory, CDx will provide project oversight and regulatory submission support for biomarker and diagnostic technologies for the Loxo Oncology at Lilly pipeline and the Lilly Oncology Business Unit (OBU) programs.
He/She will be supporting Biomarker testing related activities to support NDA/sNDA or BLA/sBLA filing and Companion Diagnostic (CDx) development plans. The successful candidate, in collaboration with both Diagnostic (Dx) and Drug (Rx) development teams, will advise on biomarker related testing such as bridging study strategies and deliverables to meet FDA (CDER and CDRH) expectations for both early and late stage clinical development programs.
In addition, he/she will assist/advise in managing the development, outsourcing, and validation of clinically applicable biomarker assays including testing execution and data analysis for the relevant Rx Regulatory submissions. This function will play a critical role in late stage clinical development to support the Eli Lilly Oncology Business Unit (OBU) programs but will also support the Loxo @ Lilly programs (early stage) as needed. This individual will be supervised and mentored/trained to become a regulatory expert in CDx development and will work directly on project teams as the CDx Regulatory representative.
The demands of this position are consistent with light office duties. This position is required to travel approximately 15%.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is based in a typical office setting.
The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Loxo Oncology, Inc. 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.