Eli Lilly and Company · 1 day ago
Associate Director - Clinical Operations
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$128K/yr - $205K/yr
9+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Associate Director of Clinical Operations will oversee all aspects of clinical studies, ensuring adherence to timelines and regulatory guidelines while leading cross-functional teams to support the execution of clinical programs.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk-based approach
Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high-quality execution
Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals
Partner with cross-functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs
Partner with cross-functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on-time study enrollment
Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts
Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient-facing materials, and vendor plans)
Assist in maintaining a quality-focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs
Engage in the planning of quality assurance activities and coordinate remediation of audit findings
Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed
Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost-effective execution, and punctual review of invoices
Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File (TMF) by performing periodic QC reviews to ensure the TMF is always 'inspection ready'
Lead, mentor, and develop a high-performing team by fostering collaboration, resolving challenges, and ensuring peak performance. Provide training and guidance to junior staff to support their growth and expertise in clinical operations
Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities
Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values
Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies
Make data-driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation
Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment
Partner with internal teams and external partners to ensure seamless execution of clinical studies. Foster strong relationships across departments to align objectives, streamline workflows, and drive strategic decision-making
Qualification
Required
Bachelor's degree in a life science, allied health field, or other relevant field (e.g. nursing, medical or laboratory technology)
At least 9 years of relevant experience
Preferred
Proven ability to lead teams, manage projects, and solve complex problems
Strong communication skills, with the ability to persuade and influence partners in sensitive, high-impact situations
High emotional intelligence, with the ability to manage both your own emotions and those of others, fostering a collaborative and positive work environment
Skilled in conflict resolution and maintaining relationships in challenging scenarios
Experience managing contracts, budgets, resources, and schedules to meet performance and project requirements
Strategic thinker with the ability to clarify and structure ambiguous problems
Experience in policy development and implementation with potential company-wide effects
Ability to build and maintain strong team dynamics, proactively preventing and resolving challenges
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
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
2026-01-17
2026-01-17
Company data provided by crunchbase