Associate Director - Clinical Research Scientist

Associate Director - Clinical Research Scientist page is loaded## Associate Director - Clinical Research Scientist locations:
US, Boston MAtime type:
Full time posted on:
Posted Todayjob requisition :
R-99534

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 an Associate Director -  Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, 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 help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail.
** Responsibilities:
** The primary responsibilities of the Verve Associate 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, guidance (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 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 by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens.

Clinical Research/Trial Execution and Support
* Design and oversee implementation of Phase lb and Ila/IIb clinical studies.
* Design and write clinical trial protocols.
* Participate in investigator identification and selection, in conjunction with 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 as required, to ensure appropriate communication of risk to study subjects.
* Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical 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)
* Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions
* Leads internal meetings to review topics and develop mitigation plans
* Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
* Serve as resource to clinical research monitors,…