Project Mgr – Drug Development (FSP)

Project Manager – Drug Development

Purpose of the Role: The Project Manager Drug Development partners with the Project Leader to proactively manage end‑to‑end development programs (from pre‑clinical to commercial), supporting the Project Leader and Project Team to identify and mitigate risk, facilitate issue identification and resolution, contingency planning, and ensure decisions are documented and communicated appropriately. The Project Manager is responsible for creating and maintaining integrated development plans, timelines and budgets for the program, as well as tracking and reporting progress.

Responsibilities

• Partner with the Project Lead and Project Team members to create a fully integrated operational plan aligned with the program strategy and company vision.
• Work cross‑functionally to build an integrated development plan aligned with goals and objectives and that anticipates and mitigates risk.
• Support the Project Lead and Project Team in scenario planning.
• Track activities to ensure project execution is consistent with the integrated development plan, budget, scope and timing; maintain documents to track and report progress to management and relevant stakeholders.
• Represent the program at governance meetings with the Project Leader.
• Prepare presentation materials with the Project Leader.
• Document meeting discussions and outcomes with clear and concise minutes.
• Ensure outcomes are clearly communicated to stakeholders.
• Ensure timely, open and effective communication to relevant stakeholders, including team members, collaborators, functional managers and partners.
• Manage the Project Team and ad‑hoc meetings in alignment with the Project Leader (agenda preparation, minute‑taking, communication of decisions, tracking and resolution of action items).
• Provide PM support for planning and preparation of documents to a quality standard required for Regulatory / Health Authority submissions.
• Ensure operational excellence in all processes in support of the business.
• Contribute to creation and management of templates, trackers, and business process documents.

Qualifications

• Education : Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
• Experience : Comparable to 8+ years of relevant experience, or an equivalency of education, training and/or directly related experience.
• Knowledge, Skills and Abilities:
• Technical and systems competency, including effective use of Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity).
• Ability to delegate and effectively prioritize own workload and that of project team members in a frequently changing environment.
• Effective oral and written communication and presentation skills.
• Proactive, solutions‑oriented and adaptable to changing priorities and situations.
• Advanced therapeutic area knowledge and clinical development guidelines and directives.
• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen.
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross‑functional project teams.
• Good judgment and decision‑making skills and capability to apply critical and analytical strategic thinking to manage complex/ambiguous situations.
• Ability to negotiate, persuade and influence others, including cross‑cultural awareness.
• Employees hired in this role may be assigned to a US government contract and, if so, would be subject to COVID‑19 vaccination and reporting requirements.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.