Loxo@Lilly Associate Director, Data Management in Raleigh, North Carolina
Loxo@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@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 Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Associate Director, Clinical Data Management is responsible for leading and overseeing data management tasks for one (or more) clinical programs from study start-up through database lock for clinical trials. The Associate Director, Data Management will manage a team within the Data Management Group and work collaboratively across multiple cross functional groups including Clinical Operations, Biostatistics and Clinical Science. The Associate Director will also be responsible for DM vendor management, contracts and relationships to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Associate Director, Data Management ensures all Data Management activities stay within full compliance of Loxo regulatory and legal policies.
Roles and Responsibilities of the Position:
Represents Data Management for one (or more) clinical programs from a strategic planning and execution capacity in program team meetings and development strategy meetings
Oversees the creation and execution of data management timelines used to coordinate and synchronize deliverables with the overall study timelines
Evaluate and design DM processes for study execution, data delivery management as well as for initiatives which require cross functional collaboration
Manage team within DM group for specific program including day to day operations, resource allocation for study, and career track development
Participate in study vendor FRP/bid process for all vendors as required
Evaluate and engage CRO/service providers for all studies and relationships as required
Monitors the progress of all data management activities on all studies to ensure project timelines are met
Proactively identifies potential program and delivery issues/risks and recommends/ implements solutions
Collaborate with Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
Performs any and all other tasks and activities as requested by CDO
Required Qualifications and Preferred 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 of 12+ years’ clinical data management experience
Demonstrated leadership, line management and project management skills
Oncology/Hematology experience strongly preferred
Prior experience with biostatistics and SAS programming preferred
Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
Knowledge of study data tabulation model (SDTM)
Must have excellent verbal, written and communication skills
Ability to work independently as well as in a team environment
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
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director level position could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described.
Available locations for this role:
South San Francisco, CA
Physical Demands/ Travel:
The physical demands of this job are consistent with light office duties . This position will travel occasionally; the average travel for this position is 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.
This position’s work environment is in an office setting.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email firstname.lastname@example.org for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.