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Loxo@Lilly Associate Director/Director, CDMS and Clinical Programming in Helena, Montana

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/Director, CDMS and Clinical Programming is responsible for the CDMS software management, 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. This role ensures all Data Management systems and activities stay within full compliance of Loxo regulatory and legal policies.

The ideal candidate will have deep experience across a wide range of clinical development activities including clinical trial databases, data warehousing, third party data integrations, and clinical data infrastructure. An understanding of global requirements for clinical trial execution, data sharing, and patient privacy, is a plus. The individual will be a initiative-taker with excellent mentorship skills, strong focus on innovation, collaboration, and will have the desire and capability to build and manage a dedicated team. The individual will also provide leadership within CDM by championing organizational change, driving engagement, and creating a climate where staff are motivated to perform at their best.

Roles and Responsibilities of the Position:

  • Manage the outsourced EDC programming function and the support model for all active EDC databases, by providing consistent team direction, guidance, and monitoring of quality of work through robust vendor governance, audits, quality plans, and oversight of key performance metrics

  • Manage the personnel resources, workload allocation, career development and compensation for all FTEs within their group. Planning horizon is typically up to 12 months

  • Develop the infrastructure, people, standard processes, and tools to build out the EDC programming capability within the department, in coordination with CDM leadership

  • Develop the outsourcing strategy, resources, and standard processes to manage the clinical programming function for the department, in coordination with CDM leadership

  • Develop partnerships and collaborations with key cross functional teams, such as Information Technology, Quality Assurance, Clinical Operations, Biostatistics and Statistical Programming

  • Support and lead the development of standards implementation activities for both internal data management as well as cross functional projects. Provide oversight for the maintenance and governance of the standards library

  • Support the evaluation and selection of future CDM systems infrastructure and solutions, including programming and data visualization tools, eSAE, and clinical data repository/data lake solutions to support standardized data review and data cleaning goals. Planning horizon is typically 6-36 months

  • Sponsor the evaluation, prioritization and execution of department projects and initiatives related to CDMS and Clinical Programming.

  • Evaluate and support the development of CDM processes for study start up, execution, and data delivery. Reviews and approves all new processes and templates impacting their area/s of oversight

  • Represents Data Management from a technology planning and execution capacity in development and/or strategic meetings

  • Sustain and grow industry knowledge with regards to innovations in trial execution best practices, database technology, and information delivery to key stakeholders (analytics, dashboards, metrics, etc.)

  • Evaluate innovative technologies, as appropriate

  • Perform all other tasks or activities as requested

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 10 years’ clinical data management/clinical programming experience and at least 6 years of managerial experience supervising direct reports in the biotech, pharmaceutical, medical device or CRO industry, in all phases of drug development.

  • 8 years of experience leading CDM technical project teams is also acceptable in lieu of 6 years of direct report management.

  • Prior experience implementing EDC system infrastructure, as well as developing the teams, operating procedures, and continuous process improvement mechanisms to support the system.

  • Demonstrated leadership and project management skills.

  • Working knowledge of common industry data programming software and applications (e.g. SAS, BI / analytics tools, EDC Programming) required.

  • Oncology experience required.

  • Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IxRS).

  • Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.

  • Knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment.

  • Must have excellent verbal and written 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 demanding environment.

  • Demonstrated ability to stay abreast of trends and the latest information in the profession.

Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director/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 above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

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 10-20% 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 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 loxoaccommodation@loxooncology.com 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.

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