Career Opportunities

Career Opportunities

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.

Data Manager, Clinical & Biomarker Data Management

Location: South San Francisco, CA or Stamford, CT or Remote

Reports To:

Director, Biomarker Operations

Position Summary

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.

This position is uniquely situated to support the Clinical Data Management (DM) team as well as the Biomarker Operations (BMO) team. Clinical DM responsibilities include managing the data flow and transfers for clinical and biomarker data received or distributed by Loxo Oncology at Lilly. This individual will also work with all study DM teams in the creation, validation and distribution of clinical data review and data reporting listings. This position will work collaboratively with the BMO team to facilitate the data transfers of biomarker data from various labs, and also support diagnostic development data activities This individual will ensure that all operations activities stay within full compliance of Loxo Oncology at Lilly regulatory and legal policies.

Roles and Responsibilities of the Position*
  • Create, execute and/or distribute data management metrics, listings, and reports, as required.
  • Receive, review the quality, and organize biomarker data and incorporate information into internal or external databases as needed.
  • Develop and update current data transfer specifications by gathering input from biomarker scientists to ensure consistent data transfers.
  • Coordinate data requirements with reference labs to ensure data collection are accurate and formatted appropriately for Data Transfer Specification.
  • Author, manage and track all Data Transfer Specifications for DM and BMO.
  • Perform import QC on all data transfers for DM and BMO.
  • Collaborate with study teams to oversee CRO/service providers for all clinical data transfer and biomarker data needs.
  • Coordinate data transfers with diagnostic development partners as needed.
  • Seek means of improving processes to reduce cycle time, increase accuracy, and decrease work effort.
  • Perform any and all other tasks and activities as requested
Required Qualifications and Background
  • Bachelor’s degree in life sciences, math, computer science or related field required.
  • 5+ years’ clinical development experience.
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • Laboratory background and/or working knowledge of commonly tested biomarkers in the oncology setting, with latest and advanced analytical tool and assay experience preferred.
  • Previous LIMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process.
  • Prior experience with data transfers or management for CDx or diagnostic developments programs in general is a plus Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
  • Excellent verbal/written communication and interpersonal skills and ability to collaborate effectively with cross-functional teams
  • Proven ability to work both independently and in a team setting
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
  • Demonstrated ability to stay abreast of trends and new information in the profession. Demonstrated leadership and project management skills.
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Strong well-rounded technical skills (MS Office; MS Word, Excel, PowerPoint).
Additional Preferred Qualifications
  • 5+ years prior oncology/hematology experience highly desirable
  • 4+ years of Sponsor experience.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.  This position will travel rarely; the average travel for this position is 0-10% with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an 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.

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