Eli Lilly and Company · 5 hours ago
Associate Director - Clinical Research Scientist
US, Boston MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$128K/yr - $205K/yr
7+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking an Associate Director - Clinical Research Scientist to lead clinical trial efforts for innovative gene editing therapies targeting cardiovascular disease, providing scientific oversight and strategic leadership throughout the trial lifecycle.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
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
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)
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
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
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
Qualification
Required
Bachelors 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
Preferred
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
Benefits
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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