Associate Director – Clinical Research Scientist Full-time

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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, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of 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 emerging from clinical and translational studies
• Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).

Regulatory Support Activities

• Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response.

Business/ customer support

• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis.
• Participate in patent development.

Scientific & Technical Expertise and Continued Development

• Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule.
• Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area
• Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects.
• Attend scientific symposia.

Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research.

Basic Requirements:

• Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
• Minimum of two years' experience in clinical development

Additional Skills/Preferences:

• 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following:
• Minimum 2 of which is in clinical development
• Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices.
• Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution.
• Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making.
• Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings.
• Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).
• Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus.
• Ability to travel to clinical sites, conferences, and regulatory meetings as needed.
• Fluent in English, verbal and written communication

Additional Information:

• Travel 10-15%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$127,500 – $204,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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