The Project Lead will aim for the successful progress of several vaccine and mabs R&D projects in various stages of development through providing solid oversight, management and excellence to Hilleman Laboratories vaccine and monoclonal antibody projects, with specific interest in early development programs, and through effective tracking and guiding activities around CMC R&D.
Responsibilities:
Proactively manage and oversee key elements of projects through monitoring, in-charge of the scope, timelines, risk, budget and quality, striving for an optimum use of resources, cost versus timelines and risk.
Define specific Product Development strategy, including for early development programs, and help the team with early R&D plan roll out definition.
Assess and provide feedback to cross-functional technical proposals and recommendations.
Manage multiple workstreams and projects. Make sound and timely decisions based on project priorities. Discern paths forward within ambiguous environments.
Maintain a deep and broad understanding of vaccine and biologics development and manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial and resource impact.
Develop a clear understanding of the content of respective HLS projects and maintain relevant knowledge throughout the project life cycle.
Support due diligence and expert review of proposals; develop good understanding of the project subject.
Establish a strong working relationship with respective project team members and functional leads to jointly ensure timely deliverables.
Guide team members in the execution of operational plans.
Track project progress against timelines, financial and quality milestones as well as report to management and, where asked, to investors. Proactively identify issues and / or obstacles, working with subject matter experts to develop resolutions and contingencies to guide the project to a successful outcome.
Closely manage project risks to ensure that mitigating activities are appropriately considered. Ensure that risks are sufficiently and regularly briefed to management
Identify synergies and efficiencies, facilitate collaboration and communication between different projects; identifying ways to accelerate project execution where possible while maintaining high quality standards.
Manage project team related documentation and communications. Assist with determination of cross-functional communication and coordination of action items.
Actively contribute to portfolio review and analysis, working closely with colleagues across the organization, external experts and Scientific Advisory Committee, contributing to continuous improvement.
Being a coach and mentor for team members that may require more guidance.
Provides vision and passion for driving technology and innovation within the vaccines and biologics portfolio
Able to operate effectively through ambiguity.
Ability to influence broadly across the organization to drive decisions, alignment, and conflict resolution for complex cross-functional issues
Is able to effectively manage multiple products
Displays and drives Hilleman’s corporate values of innovation, respect and passion, trust, integrity and agility, safety, and quality into the organization
Draws in others focused on innovation to drive better outcomes from the product.
Provide scientific leadership to a team of internal experts working on the various programs, be a mentor and resource to junior team members
Education, Experience, Knowledge And Skills:
Advanced degree (Master or Doctoral) degree in life sciences or it’s equivalent, medical-related sciences or equivalent relevant experience. Qualification in Project Management or Certified PMP is highly desirable.
Significant experience working in the pharmaceutical industry, or not-for profit vaccine development, as a project manager for vaccine development projects in global multidisciplinary teams. Desirable 10 years working experience or more
Experience with early development desirable.
Experience operating globally in a matrixed organization highly preferred.
Advanced knowledge of global research and development processes related to vaccine development.
Expert planning and tracking skills, well-organised, focused on results, capable of managing multiple projects, excellent time and self-management.
Demonstrable problem-solving abilities with ability to identify issues seeking advice as required.
Strong interpersonal skills, team player, able to work in different cultural environments, to negotiate timelines and develop effective international collaboration.
Strong critical and objective interpretation of development and scientific issues with the ability to articulate and establish processes which impact cross-functional activities.
Track record of using the latest tools and methods for state-of-the-art project management excellence.