Clinical Data Sciences Consultant-Oncology

September 20 2018
Life Sciences
Position Type
Full Time
Organization Type
Job Type
The Clinical Data Sciences group within the Clinical Labs and Data Sciences (CLDS) organization delivers creative clinical data solutions that offer people insight into Lilly medicines. We view clinical data as a critically valuable company asset. This belief guides our behavior as an organization to continuously deliver on and improve clinical data capabilities. Our organization aims inspire the clinical development strategy and translate that strategy into a clinical data strategy and molecule-specific data flow. In addition, we monitor and manage these data flows to reliably deliver data for timely, on-demand decisions. Our organization is deeply committed to the development of our people as clinical data professionals and clinical development leaders. We work to realize our vision through focus on clinical data sciences, professional development and effective partnerships.

Do you see an opportunity to set asset level clinical data strategy? Are you highly skilled in the understanding of data sciences, data collection, data flow management, data quality & integrity, data technology, data archiving, data standards, and data submissions? Does an opportunity that provides elements of clinical research from early clinical development to post launch clinical research activities sound like the job for you?

We are seeking a Clinical Data Consultant to be a cross-functional leader and key partner with Therapeutic Area Research and Business Unit Leadership. This role will provide you the opportunity to collaborate with key study partners to develop strategies and solutions to deliver data required to answer scientific questions during the drug development life cycle of the molecule. Through understanding and incorporating various techniques, approaches and data sources into the strategy, you will ensure we meet current and emerging business needs (e.g. adaptive designs, tailored therapeutics, quantitative pharmacology, connected devices, and electronic health records).

You will be responsible for providing clinical data strategy, leadership, and ownership for a particular set of trials, indications, assets, or programs. As the strategy is developed, you will consult and influence the application of the relevant sourcing strategies to meet the needs of the clinical data strategy. Other important responsibilities of this role include:

Portfolio Data Strategy

  • Develop, communicate and drive implementation of a global clinical data strategy aligned with global clinical plans for an asset.
  • Partner with asset teams to ensure clinical data strategies and plans are understood and effectively incorporated into clinical plans, protocols, data standards and plan documents.
  • Strong partnership with leadership.
  • Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations relevant to the data domain are understood, well communicated and applied to data deliverables and strategies.
  • Engages other functions as defined by the asset need (e.g. Safety Committees, Regulatory, Toxicology/PK…).
  • Understand and influence functional sourcing strategies to meet the current and emerging needs of clinical data strategies.
  • Utilizes external benchmark data to inform the clinical plans and designs for the data strategy.
  • Define and approve data quality and submission deliverables.

People Development

  • Provide leadership, mentoring, and coaching across the organization.

Shared learning and continuous improvement

  • Focus on asset and therapeutic area findings to identify and replicate best practices.
  • Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
  • Actively participate in shared learning across the organization.
  • Work with partners to increase vendor/partner efficiencies.

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Basic Qualifications
  • Bachelor's degree and 5 years of experience in clinical drug development with expertise in/or areas intersecting with clinical data management.
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • In depth knowledge of drug development processes and a deep therapeutic and molecule knowledge in the specific area of the role.
  • Ability to understand and apply clinical data flow, data quality, data interchange, data mining, and data representation principles.
  • Ability to set and implement strategies and plans to improve complex drug development processes and capabilities.
  • Effectively engage partners and influence broadly to deliver results.
  • Familiarity with clinical data tools and technologies.
  • Strong communication skills.
  • Society of Clinical Data Management certification.
  • Ability to anticipate and resolve key technical, operational, or business problems to drive solutions.
  • Demonstrated ability to focus on multiple, opposing priorities and customers simultaneously

Additional Information
Lilly 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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