CMC Project Manager

CMC Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a CMC Project Manager to join our diverse and dynamic team. As a CMC Project Manager at ICON, you will be responsible for leading and managing regulatory affairs CMC projects, ensuring successful execution and delivery of project objectives.

This role is fully embedded with a hugely innovative Biotech where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways and differentiated therapeutic antibodies within Immunology.

Key Accountabilities and Responsibilities:

• Responsible for achieving project goals, including timelines, budget, and scope.
• Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs
• Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk;
• Build strong working relationships with internal and external key stakeholders to ensure timely completion of CMC activities by continuously monitoring progress;
• Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan;
• Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team;
• Perform scenario simulations and advise on optimum development planning
• Prepare and lead project team meetings including issuance of agenda, actions and meeting minutes to be documented, communicated and committed.
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team

Qualifications:

• Life Sciences degree
• strong CMC project experience.
• Experience in working with biologics
• Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize,
• Strong analytical, problem solving and critical thinking skills with action-oriented follow through
• Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships
• MS Project, Power BI, or Planisware experience

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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