Consultant-Data Sciences

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.

Responsibilities

You will be responsible for asset level clinical data strategy including an in depth understanding of data sciences, data collection, data flow management, data quality & integrity, data technology, data archiving, data standards, and data submissions. You will help drive elements of clinical research from early clinical development to post launch clinical research activities.

Collaborate with study partners to develop strategies and solutions to deliver data required to answer scientific questions during the drug development life cycle of the molecule. Meet current and emerging business needs (e.g. adaptive designs, tailored therapeutics, quantitative pharmacology, eCOA, connected devices, and electronic health records) through understanding and incorporating various techniques, approaches and data sources into the strategy.

The Consultant role is 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 meaningful sourcing strategies to meet the needs of the clinical data strategy.

Primary Responsibilities:
1. Portfolio Data Strategy

• Develop, communicate and drive implementation of a global clinical data strategy aligned with global clinical plans for an asset.
• Partner with the other teams to ensure clinical data strategies are understood and effectively incorporated into clinical plans, protocols, data standards and plan documents.
• Positive relationship with Clinical Laboratory and Data Sciences leadership.
• Provides input for implementing the asset strategy via the clinical plan.
• 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.
• Understand and influence functional sourcing strategies to meet the 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.
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data strategies.

2. People Development

• Provide mentoring within the organization that fosters inclusion and innovation, continual improvement, and an external understanding and awareness.
• Model the Lilly leadership behaviors.

3. Shared learning and continuous improvement

• Focus on asset and therapeutic area findings to identify and replicate the most effective methodologies.
• Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
• Provide functional representation in cross-functional initiatives.
• Actively participate in shared learning across Clinical Labs and Data Sciences organization.
• Work with partners to increase vendor/partner efficiencies.

4. Asset Protection

• Understand the confidential nature of company information and takes necessary steps to ensure its protection.
• Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties.
• Accept obligation to Lilly for compliance to the integrity of the company.
• Complete readings of any policy/procedure updates including global medical, functional, and local policies and procedures

51776BR

Basic Qualifications

• Bachelor's degree
• 5 years of experience in clinical drug development with expertise in clinical data management or areas intersecting with clinical data management.
• Upper level coursework in genetics, molecular cell biology, biochemistry and cell physiology
• Minimum of 2 years of laboratory experience in a biological research, anatomical pathology, or molecular biology lab
• Proficiency in Excel and writing documents in Word

Additional Skills/Preferences

• Masters degree in molecular biology, biochemistry or cell biology
• Laboratory experience performing DNA sequencing, RNA sequencing, immunohistochemistry, RT-PCR and enzyme based assays
• Experience in biomarker assay validation
• Automated data review tool experience
• Knowledge of cancer cell biology and common driver mutations
• Proven knowledge of drug development processes.
• Deep therapeutic and molecule knowledge in the specific area of the role.
• Proven capability to understand and apply clinical data flow, data quality, data interchange, data mining, and data representation principles.
• Proven ability to set and implement strategies and plans to improve complex drug development processes and capabilities.
• Society of Clinical Data Management certification.
• A strong understanding of the clinical drug development processes and the interdependencies of the various tasks/functions.
• Ability to anticipate and resolve key technical, operational, or business problems.

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.