The process of discovering a drug and taking into to market is a lengthy and highly complex procedure, which involves cross-functional elements of preclinical research, CMC, regulatory and medical project management. My client, a globally leading Biotech company in the field of Biotherapeutics, is currently seeking the expertise of a Project Leader to further advance their clinical stage, diverse large molecule pipeline. This pivotal position in the company shall chair these cross-functional project management meetings to ensure a healthy progression of drug candidates to the clinic.
Project Leader Key Responsibilities:
- Lead responsibility for project management of preclinical and clinical stage development programs.
- Manage and coordinate the efficient and effective achievement of deliverables and milestones for the development projects by planning, scheduling and overseeing work plans and all associated activities to ensure successful and timely completion.
- Manage and oversee the work of consultants, vendors, partners, collaborators and internal team members to meet development goals in the areas of clinical, regulatory, pre?clinical toxicology, manufacturing, research, patents, marketing, alliance management, finance, etc.
- Research and summarize program information for response to external requests, project proposals, reports and external meetings.
- Develop tools and mechanisms for monitoring program progress for intervention and problem solving with function heads and other project managers.
- Analyze and critically review the status of programs, timelines and budgets within context of scientific milestones, financial impact and long?term strategic goals.
- Prepare and disseminate project update reports and ensure timely reporting to the Company’s executives and Board.
- Facilitate, organize and maintain an extensive set of technical reports and electronic files, track status of reports and documentation utilizing the Company’s IT infrastructure.
- Bachelor’s degree in a scientific discipline minimum, MSc/PhD or MBA preferred.
- Experience in (bio)pharmaceutical project management or drug development, including managing multiple overlapping projects and budgets.
- An understanding of quality systems required to cover GMP, GLP and GCP activities.
- Proven track record and experience in managing small teams and complex budgets to deadlines.
- Experience in overseeing the work of consultants, vendors, partners, and collaborators and managing those relationships successfully.
- Experience with regulatory filing requirements, especially in support of IND/CTA filings.
If you have the suitable background, please apply and call 01619427163 for more information.