CMC Project Manager

ICON plc

3d • Onsite

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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.

Requirements

• 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

Nice To Haves

• 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

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

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level