Senior Clinical Project Lead

JOB TITLE: Sr Clinical Project Lead

REPORTS TO: VP of Clinical Operations

LOCATION: Seaport, Boston, MA (Hybrid- 3 days on-site ) DATE PREPARED: July 9, 2025

JOB SUMMARY:

We are seeking an experienced Sr Clinical Project Lead (CPL) [AH2] with strong leadership, organizational, and communication skills to join our highly motivated and dedicated team at AVEO Oncology. This individual will play a pivotal role in the planning, execution, and oversight of early- and late-phase oncology clinical trials, including dose escalation studies. The ideal candidate will have proven success in managing clinical trial start-up, CRO/vendor oversight, and cross-functional team leadership within the biotech or pharmaceutical industry.

PRINCIPAL DUTIES:

* Lead the planning and execution of oncology clinical trials, including first-in-human and dose escalation studies

* Responsible for the clinical operations and logistical aspects of assigned Phase I/II trial from start-up to close-out.

* Monitor the study budget; review and approve study-related invoices.

* Manage all aspects of clinical trial start-up, including site feasibility, selection, contract negotiation, and regulatory submissions

* Oversee and manage CROs and third-party vendors to ensure study timelines, budgets, and quality standards are met

* Serve as the primary point of contact for internal and external stakeholders, including investigators, study sites, and regulatory bodies

* Collaborate with cross-functional teams including Clinical Operations, Medical, Regulatory, Biometrics, and CMC

* Collaborate with AVEO Medical Monitor to determine the medical and scientific needs, and apply them to the protocol and study logistics.

* Develop and maintain clinical trial documentation including protocols, monitoring plans, study reports, and TMF oversight

* Drive resolution of clinical trial issues and identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans.

* Support development of clinical budgets and track study expenditures

* Monitor patient recruitment, enrollment, and study milestones to ensure trial progress

* Ensure adherence to ICH-GCP, regulatory guidelines, and company SOPs

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

* Bachelor's degree in Life Sciences or a related field (advanced degree preferred)

* Minimum of 5 years of clinical research experience of being a Clinical Trial Manager at a pharmaceutical or biotech company

* Oncology experience is required, preferably in solid tumors or hematologic malignancies

* Experience with dose escalation and early-phase oncology trials with at least 3 years of experience is strongly preferred

* Proven success with clinical trial start-up and site activation

* Demonstrated experience in CRO/vendor oversight and clinical team leadership

* Strong understanding of ICH-GCP, FDA regulations, and global clinical trial requirements

* Exposure to IND-enabling studies and regulatory filings

* Experience with electronic clinical systems (e.g., CTMS, eTMF, EDC)

* Excellent project management, communication, and problem-solving skills

* Highly motivated individual, a self-starter with minimum oversight required to accomplish goals.

* Knowledge of project management skills, capable of managing multiple activities with respect to priorities.

* Good command of MS-Office (Outlook, Word, Excel, PowerPoint, Project)

* Ability to work in a fast-paced, evolving environment with a high level of autonomy

KEY PERSONAL ATTRIBUTES:

*

* Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).

* The ability to work cross-functionally is essential.

* Excellent communication skills, oral and written, are required.

* Strong knowledge of clinical research and the drug development process required.

* Proven ability to work independently and in a team setting is essential.

* High level of autonomy and motivation.

* Quality focused and well organized.

* Ability to handle multiple tasks and to prioritize.

* Ability to synthesize the information, good presentation skills.

* Excellent decision-making and problem-solving capabilities.

* Capability to challenge decision and status quo.

* Ability to anticipate and timely escalate issues and to define appropriate action plans

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.