Senior Manager, Clinical Trial Management

Position Summary:

Upstream Bio seeks a resourceful, data-driven and integrative thinker to drive the planning and execution of fully-outsourced clinical trials, from initiation to completion. This individual will ensure compliance with regulations, timelines, budgets, and quality standards. This role will support the Clinical Operations Indication Lead in day-to-day trial operations. This individual will have the ability to work in a small, fast-paced, and patient-focused environment.

The Senior Clinical Trial Manager will have the following skills:

• Trial Management: Drive the execution of clinical trials from initiation to completion, ensuring
• adherence to timelines, budgets, and quality standards. Ability to synthesize scientific, clinical and business considerations into a cohesive trial strategy. Solid understanding of the clinical indication and patient population.
• Team Leadership: Effective collaboration and communication with the cross functional study team. Strong communication skills.
• Regulatory Compliance: Ensure that all clinical trials comply with Good Clinical Practice (GCP),
• ICH guidelines, and relevant regulatory requirements. Deep understanding of the regulatory, competitive, and therapeutic landscapes.
• Site Management & Relationship: Ensure quality trial conduct by sites, while fostering partnerships with KOLs.
• Vendor Management: Collaborate with study vendors and key stakeholders to ensure data integrity and accuracy across all data types. Manage vendor deliverables on budget and within timelines.
• Problem Solving: Address and resolve any issues that arise during the trial. Ability to adapt to changing program needs and offer an innovative approach to problem solving.

Key Responsibilities:

• Lead or contribute to cross functional trial execution from planning to close-out, in alignment with the Indication Lead, program strategy and company goals
• Provide operational management of clinical trials including trial budget, tracking & reporting of trial deliverables, developing and managing timelines.
• Contribute to and oversee internal and external project materials, including study plans, manuals & specifications, systems, and regulatory submissions
• Support site trial conduct and help foster relationships with site staff and KOLs
• Ensure audit and inspection readiness and compliance across all clinical trial activities, including completeness of the TMF
• Lead and contribute to the successful conduct of the Study Team Meeting and other operational forums
• Contribute to CRO/vendors identification, selection and oversight; Provide oversight for relevant vendors-related activities, including contracting, budgeting and documentation
• Closely collaborate with CRO/vendors & key stakeholders to secure end-to-end data integration activities (i.e. eCOA, EDC, labs, imaging), including review of data specifications
• Assess, manage, mitigate and report risks throughout the trial. Collect and analyze qualitative and quantitative oversight data to identify risks and manage mitigations, investigations, action plans, and resolution.
• Contribute to other activities, such as team training, process development etc.

Qualifications:

• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable. 6 years of relevant clinical trial operations experience, and strong project trial management skills
• Vendor oversight
• Strong knowledge of ICH GCP and global regulatory and compliance requirements for clinical research. Experience with regulatory inspections, a plus.
• Strong critical thinking, with ability to understand the big picture as well as the important details that may impact the big picture.
• Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications
• Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing.
• Able to travel up to 10–25%, as required

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.

Compensation:

Base Compensation for this role will depend on a number of factors including a candidate’s

qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.