Sr. Director- Trial Management

BioSpace; Boston (MA); In loco; USD 177.000 - 295.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus eligibility

Comprehensive benefits

401(k)

Descrizione del lavoro

Lilly and Verve Therapeutics are seeking a Senior Director, Trial Management to provide strategic and operational leadership for the trial management function across Verve’s early development programs. This leader will guide trial management leaders, align practices, and advance an integrated operating model between Verve and Lilly to enable clear, rapid, and quality delivery of studies.

The role emphasizes cross-functional collaboration, governance, and data-driven decision-making to support

Competenze

• Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred.
• Significant clinical operations or trial management experience within a sponsor organization.

Mansioni

• Lead and develop trial management leaders, setting clear expectations for performance, collaboration, and execution.
• Standardize and continuously improve trial management best practices, tools, and operating rhythms across programs.
• Drive harmonization of trial management processes across Verve and Lilly to support a consistent and scalable operating model.
• Serve as an active member of the Clinical Development Operations leadership team, contributing to strategic planning, organizational effectiveness, and functional direction.
• Provide oversight across clinical programs to ensure delivery against timelines, quality expectations, budgets, and study goals.
• Partner closely with cross-functional team members including Clinical Development, Regulatory, Data Management, Patient recruitment/retention, Study start up, Medical Writing, Supply Chain, Quality, Clinical Compliance, and other key functions to support aligned study execution.
• Work with Compliance and Oversight to strengthen governance, escalation, and decision-making processes to identify and address operational risks early.
• Ensure teams apply a risk-based approach to planning, study oversight, and issue resolution.
• Oversee CRO and vendor strategy within the function, including expectations for performance, partnership, and accountability.
• Support development and refinement of SOPs, workflows, and business processes that promote quality, compliance, and consistency across trials and programs.
• Champion compliance with GCP, ICH, and applicable global regulatory requirements, while supporting inspection readiness.
• Monitor key operational metrics and use data-driven insights to improve execution, resource planning, and leadership visibility.
• Foster a culture aligned with Team Lilly expectations, including collaboration, accountability, inclusion, and continuous improvement.
• Coach, mentor, and develop talent within the trial management organization to strengthen capability and succession depth.
• Represent the trial management function in cross-functional and leadership forums.

Conoscenze

Trial leadership

GCP/ICH knowledge

Cross-functional leadership

Vendor management

Data-driven decision making

Strategic planning

Risk management

Mentoring / coaching

Formazione

Bachelor's degree in science

Advanced degree preferred

Strumenti

Clinical trial systems

Descrizione del lavoro

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Verve Therapeutics, a Lilly Research Labs subsidiary, is a clinical-stage genetic medicines company on a mission to solve cardiovascular disease. Founded by leaders in cardiovascular medicine and gene editing, Verve is developing one-time gene editing treatments aimed at turning chronic management into a single-course cure. Its lead programs target PCSK9 and ANGPTL3 to lower LDL-C, the root cause of cardiovascular disease.

The Senior Director, Trial Management provides strategic and operational leadership for the trial management function across Verve’s early development gene editing clinical programs. This role leads trial management leaders, strengthens consistency in execution, and advances standard practices to support high-quality, efficient, and compliant delivery.

This leader will play a key role in harmonizing ways of working across Verve and Lilly processes, helping build an integrated operating model that enables clarity, speed, and quality across the portfolio.

As a member of the Development Operations leadership team, this individual will contribute to broader functional priorities, organizational decisions, and cross-functional alignment.

Key Responsibilities

• Lead and develop trial management leaders, setting clear expectations for performance, collaboration, and execution
• Standardize and continuously improve trial management best practices, tools, and operating rhythms across programs
• Drive harmonization of trial management processes across Verve and Lilly to support a consistent and scalable operating model
• Serve as an active member of the Clinical Development Operations leadership team, contributing to strategic planning, organizational effectiveness, and functional direction
• Provide oversight across clinical programs to ensure delivery against timelines, quality expectations, budgets, and study goals
• Partner closely with cross-functional team members including Clinical Development, Regulatory, Data Management, Patient recruitment /retention, Study start up, Medical Writing, Supply Chain, Quality, Clinical Compliance, and other key functions to support aligned study execution
• Work with Compliance and Oversight to strengthen governance, escalation, and decision-making processes to identify and address operational risks early
• Ensure teams apply a risk-based approach to planning, study oversight, and issue resolution
• Oversee CRO and vendor strategy within the function, including expectations for performance, partnership, and accountability
• Support development and refinement of SOPs, workflows, and business processes that promote quality, compliance, and consistency across trials and programs
• Champion compliance with GCP, ICH, and applicable global regulatory requirements, while supporting inspection readiness
• Monitor key operational metrics and use data-driven insights to improve execution, resource planning, and leadership visibility
• Foster a culture aligned with Team Lilly expectations, including collaboration, accountability, inclusion, and continuous improvement
• Coach, mentor, and develop talent within the trial management organization to strengthen capability and succession depth
• Represent the trial management function in cross-functional and leadership forums

Basic Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred
• Significant clinical operations or trial management experience within a sponsor organization

Additional Skills/Preferences

• Demonstrated success leading leaders and building high-performing teams in a matrixed clinical development environment
• Strong experience overseeing global clinical trials across multiple phases of development
• Deep understanding of GCP, ICH, and applicable regulatory requirements
• Proven ability to standardize processes, implement operational improvements, and lead through change
• Strong critical thinking, judgment, and problem-solving skills
• Demonstrated ability to balance strategic leadership with operational execution
• Experience supporting organizational integration, process harmonization, or operating model evolution preferred

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $294,800.

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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