Verve
Healthcare
Director-ClinicalResearchScientist
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“Director - Clinical Research Scientist at Verve. Skills: Clinical Research, Gene editing therapies, Cardiovascular disease. Lead development of global clinical development strategy. Lead early phase clinical plan”
Industry & Context.
Mitigation plans; Resolve regulatory issues
Travel 10-15%
What They're Looking For.
Must Have
5+ years experience, Experience with clinical trial protocols, Experience with clinical biomarker strategy, Experience with clinical pharmacology data, Experience with safety data, Experience with regulatory submissions, Experience with IND, Experience with Investigator Brochure, Experience with FDA advisory committee, Experience with regulatory response, Experience with external experts, Experience with medical community, Experience with pre-clinical data, Experience with clinical pharmacology data, Experience with clinical data, Experience with medical field, Experience with scientific developments, Experience with clinical practice trends, Experience with access trends, Experience with therapeutic area, Experience with development projects, Experience with scientific symposia, Experience with portfolio strategy
Nice to Have
Significant experience with translational biomarker strategies, Integration of early-phase data into clinical development plans is a plus
What You'll Do.
Lead development of global clinical development strategy
Lead early phase clinical plan
Provide scientific leadership
Develop models of drug exposure
Develop models of response
Develop and coordinate implementation of Phase lb studies
Develop and coordinate implementation of Ila/IIb clinical studies
Compose and write clinical trial protocols
Collaborate on investigator identification
Collaborate on investigator selection
Influence site strategy
Interact with consultants
Interact with clinical investigators
Plan worldwide clinical trials
Initiate worldwide clinical trials
Conduct worldwide clinical trials
Approve risk profiles
Review local informed consent documents
Approve local informed consent documents
Implement clinical biomarker strategy
Review emerging clinical trial data
Analyze emerging clinical trial data
Interpret emerging clinical trial data
Translate findings into strategic program decisions
Oversight of clinical trial activities
Lead cross-functional meetings
Lead key decision making meetings
Develop mitigation plans
Assist in planning process
Engage in study start-up meetings
Provide training to investigators
Provide information to investigators
Serve as resource to clinical research monitors
Serve as resource to investigators
Serve as resource to ethical review boards
Support planning of symposia
Support planning of advisory board meetings
Support planning of meetings with health care professionals
Engage in data analysis
Develop scientific data dissemination
Prepare final reports
Contribute to development of presentations
Contribute to development of abstracts
Contribute to development of publications
Represent company as scientific leader
Provide congress support
Support preparation of regulatory reports
Support preparation of medical sections of IND
Support preparation of Investigator Brochure
Support preparation of FDA advisory committee regulatory hearings
Support communications with regulatory agencies
Resolve regulatory issues
Establish collaborations with external experts
Maintain collaborations with external experts
Establish relationships with external experts
Maintain relationships with external experts
Establish collaborations with leaders with vision
Maintain collaborations with leaders with vision
Establish relationships with leaders with vision
Maintain relationships with leaders with vision
Establish collaborations with medical community
Maintain collaborations with medical community
Establish relationships with medical community
Maintain relationships with medical community
Keep updated with pre-clinical data
Keep updated with clinical pharmacology data
Keep updated with clinical data
Critically read medical literature
Evaluate medical literature
Keep updated with medical developments
Keep updated with scientific developments
Influence portfolio strategy
How You'll Work.
Team & Collaboration
Cross-functional leadership; Cross-functional teams; Clinical team; Medical team; Cross-functional meetings; Key decision making meetings
Communication Scope
Presentation skills; Scientific conferences; Advisory boards; Regulatory meetings; Scientific data dissemination; Public speaking
Process & Methodology
Program execution, Program-level decisions, Development strategy, Clinical development strategy, Early phase clinical plan
Full Job Description
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 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. **Organization Overview:** Verve, a wholly owned subsidiary of Eli Lilly, is seeking a Senior Director - Clinical Research Scientist (CRS) to help lead clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in collaboration with the Clinical Research Physician and cross-functional leadership driving clinical strategy, regulatory alignment, and program execution, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and direct biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external partners. **Responsibilities:** The primary responsibilities of the Verve Senior Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, mentorship (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilit
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