Program Manager Clinical Development

Program Manager, clinical development

Our client is an exciting, rapid growing publicly listed clinical stage biopharmaceutical business focussed on establishing best in class teams across all its functions. In April 2021, the company secured financing of $125 million and in June 2021 successfully completed an IPO on the Nasdaq. To date, the company has raised $315.5 million, and is engaged in a major expansion of its team in Ireland.

Job Spec

· Provide PM oversight to the cross-functional program teams responsible for the execution of various projects including large, complex clinical trials from planning and design to execution and close out. 

· Work closely with cross-functional teams, and assigned clinical project managers to develop the scope, deliverables, required resources, work plan, budget, and timing of projects.

· Work closely with CMC, Device, Clinical Sciences and Clinical Operations, in project delivery, reporting project status to senior management on a regular basis.

· Deliver on projects and programs in all areas of the business, non-clinical, clinical trials, pharmacokinetics and pharmaceutical development.

· Monitor project/program progress against the established plans and ensure compliance with plans.

· Report on project budget working with the Project teams to understand budget status and reporting this to Finance.

· Calculate drug supply needs, liaise with CMC on Clinical Supply Management and re-supply needs.

· Work with other program managers to identify risks and opportunities across multiple projects within the department.

· Monitoring and manage risks during development of the program, with timely escalation to senior management with recommendations for mitigation and control.

· Produce program reports as required

Experience and Qualification Requirements:

· BS or equivalent with a minimum of 5 years of relevant hands-on Project Management/Program Management experience role in the pharmaceutical industry/CRO.

· Clinical research and / or clinical trial experience is required.

· PMP certified, excellent project management skills, including leadership and problem-solving skills.

· Experience in working with internal and external stakeholders from all disciplines and at all levels of the organisation.

· Experience in Phase II, Phase III clinical trials is preferable.

· Strong leadership, communication, management and organizational skills, conflict resolution

· Capable of managing several different stakeholders.

· Ability to manage different project demands in a fast-paced environment.

· Maintain a professional and positive attitude and present clear instruction/direction to team members.

· Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team.

· "A blend of conventional pharma plus biotech experience and the attitude and ability to be effective in a lean, small company environment

· Flexible, able to adjust, embrace and drive change.

· An entrepreneurial, business-oriented mindset and a strong fit with the team and willing to “roll their sleeves up”.

· Resilient, energetic and enthusiastic.

CV’s to Gerry Kennedy at gerry@rftgroup.ie /++ 353 (0)1 2302400