Director - Clinical Research Scientist

Eli Lilly and Company • Boston, MA

1d • $193,500 - $338,800 • Onsite

About The Position

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.

Requirements

• Bachelor's degree in a health, medical, or scientific field and 12+ years of pharmaceutical experience with contributions to at least one of the following: drug/clinical development fields, such as epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs.
• 7+ years of clinical experience with advanced health/medical/scientific degree (For example in Pharmacology, Physiology, Microbiology or related field) Or graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner)
• Demonstrated experience leading complex clinical programs and influencing regulatory strategy
• Proven ability to operate effectively at senior leadership and governance levels
• Strong track record of cross-functional leadership and influencing decision-making across organizations
• Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best standards.
• 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 excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings.
• Previous experience in developing relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).

Nice To Haves

• Significant experience with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus.

Responsibilities

• Help lead the development and execution of the global clinical development strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions.
• Collaborate with clinical pharmacologists and statisticians while providing scientific leadership to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to inform program-level decisions and optimize development strategy
• Develop and coordinate implementation of Phase lb and Ila/IIb clinical studies.
• Compose and write clinical trial protocols.
• Collaborate on investigator identification and selection while influencing site strategy at a program level, in conjunction with clinical team.
• Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials with accountability for execution, quality, and timelines.
• 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 translate findings into strategic program decisions
• Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions
• Leads cross-functional and key decision making meetings to review topics and develop mitigation plans
• Assist in planning process and engage 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.
• Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
• Engage 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
• Represent the company as a scientific leader in providing congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet leaders with vision, and engage in customer events).
• Support/direct 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 resolve regulatory issues, including regulatory response.
• Establish and maintain appropriate collaborations and relationships with external experts, leaders with vision, and the general medical community on a national and possibly international basis.
• 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.
• Influence portfolio strategy and cross-program alignment through senior leadership engagement
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior