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.

Senior Manager, Clinical Data Management

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

Reports To:

Associate Director, Clinical Data Management

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.

The Senior Manager is responsible for leading and overseeing data management tasks from study start-up through database lock for clinical trials.  This individual works collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables follow standard operating procedures and regulatory agency guidelines. The Senior Manager ensures all clinical trial operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*

  • Represents Data Management at study team meetings with responsibility for operational execution of DM activities
  • Manages a study or compound team within the DM group
  • Creates and tracks data management timelines to coordinate and synchronize deliverables with the overall study timelines
  • Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)
  • Executes and/or distributes data management metrics, listings, and reports, as required
  • Effectively applies knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.) to data collection and DM plans
  • Collaborates and oversees CRO/service providers on assigned studies
  • Executes/manages all data management activities on assigned studies to ensure project timelines are met
  • Continually seeks means of improving processes to reduce cycle time and decrease work effort
  • Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
  • Proactively identifies potential study issues/risks and recommends/ implements solutions
  • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables
  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
  • Works with partners to increase vendor/partner efficiencies
  • Performs 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. Master’s degree in life sciences, math, computer science or related field preferred
  • Minimum 10 years’ clinical data management experience, of which 3 must be at a sponsor
  • Demonstrated leadership and project management skills
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • 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 and interpersonal skills required for working successfully in a cross-functional team environment
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
  • Proven ability to work both independently and/or 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

Additional Preferred Qualifications

  • 5+ years prior oncology/hematology experience highly desirable
  • 5 + years of sponsor experience preferred
  • Recent Phase 3 registration study and submission experience preferred
  • Direct report experience preferred

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally (15-20%) 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.