3290 Project Manager (CMC / Technical Development Team)
The Technical Development Team Project Manager (TDT PM) partners with a Technical Development Leader (TDL) to manage technical development team(s) in defining and implementing CMC strategies and activities associated with developing clinical candidates from pre-entry into humans until launch.
He/she provides advanced project and process management expertise including project planning and scheduling, resource forecasting, performance monitoring and facilitation of communication and decision making to help drive assigned projects to a successful outcome.
Applies drug/CMC process development knowledge and project management expertise to manage TDT(s) and partners/CMOs for multiple projects across various platforms (including large and small molecules, combination products/devices, new modalities), from pre-EIH though approval.
Establishes and maintains integrated project schedules and manages/reduces risk associated with CMC critical path.
Actively manages project resource forecast and variance in collaboration with Project Team, finance and cross-functional resource planners.
Ensures TDT is successful in making progress toward its objectives and adheres to timelines, milestones and resource forecast as per approved plans.
Drives business processes for TDTs including proactive risk assessment, lessons learned, governance reviews; adapts processes and tools to fit project needs.
Demonstrates an end-to-end enterprise mindset to increase the value to the assigned projects.
Facilitates cross-functional communication and decision making to ensure alignment within TDT and with internal/external stakeholders.
Keeps all relevant stakeholders updated on project status, key risks and issues; keeps all TDT project-related information current in information systems.
Applies agile principles to TDTs to ensure fit for purpose meetings, fast and focused decisions, transparent communication.
Drives the projects in the context of broader portfolio (e.g. facilitates tradeoff resource decisions within TDT and across TDTs).
Ensures optimization of TDT dynamics, performance and results through effective use of project management and tools (effective meeting facilitation).
Acts as role model for implementing change into organization (e.g. proactively identifies & leads continuous improvement opportunities and encourages smart risk taking at TDT level; advocates within TDT for broader initiatives).
Acts as a valuable member of the overall Project Team System (e.g. shares best practices and lessons learned).
Participates in departmental or cross-functional initiatives and assignments.
BS degree in Life Sciences; advanced degree (M.S/PhD) is preferred.
5+ years in the pharmaceutical/biotech industry.
3+ years drug development Project Management experience.
PMP certification is a plus.
Strong knowledge of the drug development process.
Strong knowledge with experience with end-to end CMC process development; relevant regulatory, quality and cGMP expertise is strongly preferred.
Proven ability to manage cross-functional teams and development projects and to apply advanced project management skills, methodologies and tools.
Strong collaborative and relationship-building skills; demonstrated ability to effectively partner and influence internal and external stakeholders.
Excellent verbal and written communication skills; must be able to effectively communicate/articulate TDT strategy and deliverables to team members and external business partners.
Demonstrated ability to exercise independent judgement in obtaining results and to handle multiple priorities in a fast paced, ever-changing, team-based environment.
Proven ability to think strategically including assessment of business impact of technical decisions (e.g. scenario planning/risk assessment/trade off decisions from portfolio and end-to-end development perspectives.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.