Associate Director - Clinical Operations at Lilly

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

187000.0

Posted On

02 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Project Management, Team Leadership, Regulatory Compliance, Data Analysis, Budget Management, Vendor Management, Cross-Functional Collaboration, Quality Assurance, Conflict Resolution, Strategic Thinking, Emotional Intelligence, Patient Recruitment, SOP Development, Audit Coordination, Training and Development

Industry

Pharmaceutical Manufacturing

Description

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 Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts. 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. Basic Qualifications/Requirements: 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. Additional Skills/Preferences: 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. 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. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $187,000 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. #WeAreLilly

Responsibilities

Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines. Lead internal clinical trial team meetings and partner with cross-functional teams to support the strategic development and execution of clinical programs.