Clinical Project Manager

COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa companies are advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

SUMMARY:

Centessa is seeking a Clinical Project Manager (CPM) or Sr. CPM that will be accountable for driving operational excellence within one or more Centessa clinical stage studies. The Clinical Project manager will partner with the cross functional team to align goals and internal activities with an extensive network of external partners.  In addition, the CPM/Sr. CPM will be accountable for the overall project(s) including definition of the operational strategy, management of timelines, cost, quality, and risk assessment and mitigation. The role requires active involvement, to meet schedules or resolve problems or conflicts, and entails frequent interaction with collaborators, vendors, consultants, functional peer groups at various management levels and senior management.  

RESPONSIBILITIES:

• Leads the planning and communication with cross functional teams to ensure proper execution and conduct of the clinical trials
• Reviews and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol
• Represents and leads the study team to design, develop and deliver the study to agreed upon timelines
• Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating when appropriate
• Develop and manage critical study documents and plan(s)
• Assist study team with preparation for audits/inspections
• Drives the review and finalization of clinical study-related documents such as protocols, protocol amendments, and CSRs
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Drive critical clinical trial activities including trial site activations, recruitment, and database lock
• Maintain project dashboards, Gantt charts, finance systems, and documents to track and report on progress
• Drive efficient decision making by acting as a key liaison between the project team and stakeholders while effectively communicating project status and progress to management, partners, and governance teams
• Manage interdependencies and connections between study-level functions and ensure visibility and alignment
• Facilitate cross-functional study team meetings in preparing agendas, presentation materials, and meeting minutes that ensure follow up of action items
• Provide periodic status reports regarding study timelines, accruals, etc. as requested
• Provide support for the planning and preparation of documents to a quality standard required for Regulatory/Health Authority submissions
• Work effectively in a global and virtual environment with an international team, operating across US, EU, and Asia time zones
• Provides oversight for the setup, maintenance, and close out of the Trial Master File and ensures it is complete and inspection ready

QUALIFICATIONS:

• Strong communication, collaboration, interpersonal skills, and influence to accomplish work without formal authority and to ensure optimal team performance.
• Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and global team members.
• Ability to deal with multiple priorities with aggressive timelines
• Excellent analytical and organizational skills (resources, timelines, cost/risk/benefit analysis, and overseeing data management)
• Working knowledge of project management principles and practices with the ability to thrive in a fast-paced dynamic environment (PMP certification is an advantage)
• Working knowledge of current global regulatory requirements and strong knowledge of ICH guidelines and GCP
• Able to recognize need(s), find solutions and take initiative to address in proactive manner.
• Ability to find creative solutions to issues impacting timelines and budgets

EXPERIENCE:

• Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
• 8+ years’ experience in the life sciences industry, with 5+ years of Project Management/Clinical Trial Management experience in clinical drug or program development or equivalent academic experience in clinical trials.
• Experience in rare disease, CNS and/or Oncology within global clinical trials preferred

POSITION: Full-Time, Exempt, Remote Work with occasional travel

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.