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 Associate Director, Regulatory, CDx will provide project oversight and regulatory submission support for biomarker and diagnostic technologies for the Loxo Oncology at Lilly pipeline, in addition to supporting program management for diagnostics projects. Supporting Companion Diagnostic (CDx) development plans, the successful candidate, in collaboration with both Diagnostic (Dx) and Drug (Rx) development teams, will advise on the managing the CDx partners and CROs developing diagnostic assays, coordinating transfer of materials and knowledge as well as collaborating with partners towards timely CDx regulatory submissions in a small fast-paced, dynamic work environment. In addition, he/she will assist/advise in managing the development, outsourcing, and validation of clinically applicable biomarker assays. This function will play a critical role in R&D, with emphasis on later stage diagnostic development associated with Loxo Oncology at Lilly’s programs. This individual must perform with a high degree of independence and will work directly on programs as an established regulatory expert in CDx development.
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 an office.
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.