Associate Director - Clinical Research Scientist

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 employees 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’re looking for people who are determined to make life better for people around the world.

Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for innovative gene editing therapies targeting cardiovascular disease. In this role, the CRS provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity, regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams on trial implementation, protocol review, publications and data dissemination, and contributes to regulatory submissions and biomarker strategies.

This is a high-visibility position offering the opportunity to drive clinical development and engage with key external stakeholders.

The primary responsibilities of the Verve Associate Director - CRS relate to early-phase gene editing compounds targeting cardiovascular disease.

The CRS ensures all activities of the medical team comply with applicable local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research, aligned with the medical vision.

The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

• Clinical Planning:
  Contribute to the development of the overall strategy and early-phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions.
• Collaborate with pharmacokineticists and statisticians to provide clinical support for PK/PD modeling and trial simulation to optimize dosing regimens.

Clinical Research/Trial Execution and Support

• Design and oversee implementation of Phase Ib and IIa/IIb clinical studies.
• Design and write clinical trial protocols.
• Participate in investigator identification and selection, in conjunction with the clinical team.
• Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials.
• Review and approve risk profiles and local informed consent documents to ensure appropriate communication of risk to study subjects.
• Collaborate with clinical and research teams to implement the clinical biomarker strategy for early-phase studies.
• Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g., investigator meetings, monitoring committees, advisory boards).
• Partner with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions.
• Lead internal meetings to review topics and develop mitigation plans.
• Assist in planning processes and participate in start-up meetings and other activities to provide training and information to investigators and site personnel.
• Serve as a resource to clinical research monitors, investigators, and ethical review boards to address questions or clarify issues during the conduct of the study.

Scientific Data Dissemination/Exchange

• Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
• Participate in data analysis, development of scientific data dissemination, and preparation of final reports.
• Contribute to the development of presentations, abstracts, and publications from clinical and translational studies.
• Provide congress support (e.g., answering questions at exhibits, presenting orally and in posters, staff medical booth, engaging with thought leaders, and participating in customer events).

Regulatory Support Activities

• Support/assist in the preparation of regulatory reports, including medical sections of the IND and Investigator Brochure, and regulatory hearings or responses.

Business/Customer Support

• Establish and maintain collaborations with external experts, thought leaders, and the medical community on national and international levels.
• Participate in patent development.

Scientific & Technical Expertise and Continued Development

• Understand and stay updated on preclinical, clinical pharmacology, and clinical data relevant to the molecule.
• Critically read and evaluate medical literature; stay informed of developments in the relevant therapeutic area.
• Know current trends and projections for clinical practice and access in the therapeutic area(s) relevant to development projects.
• Attend scientific symposia.

Other activities include internal and external training,…