Director of Project Management-Pharmaceutical
IN Long Island, NY OR Ohio
The Company, develops, manufactures, and supplies high quality sterile injectable pharmaceutical drugs for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
Nature and Scope
The PMO (Project Management Office) Director is responsible for managing the end to end cross functional ‘idea to launch’ process for the development, approval manufacture and launch of new products. The incumbent will be responsible for leading the coordination of activities across multiple stakeholders in order to ensure timely and efficient product, ANDA and NDA, launches.
Essential Duties and Responsibilities
Performs project management activities in order to ensure efficient and timely new product launches. The incumbent manages and tracks projects and project teams by way of project charters, ensuring the appropriate individuals complete tasks and the final versions of documents/ outputs are in place.
- Create and Deliver an overall Company Project Management strategy.
- Lead the Corporate Project Management Office while acting as a clearinghouse for information, e., collecting from and disseminating to key stakeholders, ELT, and Departmental PMs.
- The PMO (Project Management Office) Director further monitors execution, communicates priorities and their adjustments, manages continuous improvement, and facilitates cross-functional collaboration to achieve strategic business goals.
- Accountable for the overall cross functional project performance including coordination of the integration of project activities and project resources, and mitigation and management of execution risks.
- The departmental PMs will be responsible for management/communication of goal and metric setting, and the day to day project activities within the department, coordination of the integration of project activities and project resources, and risk mitigation and management.
- Plan and deliver allocated product launches end-to-end
- Ensure the development of detailed project plans, to include objectives, timelines and responsibilities, to track and communicate project progress across the organization.
- Partner with Marketing, Regulatory Affairs, Research & Development, Medical Affairs (including Clinical Affairs), Materials Management, Quality, and Manufacturing leads to define critical paths. Ensure timely execution of critical tasks, milestones and deadlines are met.
- Ensure functional area deliverables are understood, cross-functionally aligned, execution of deliverables and timelines are on track.
- Own the logistics plan for stage-gate decision process and core team meetings
- Manage core team meetings and portfolio management committee meetings related to the selected portfolio.
- Ensure that performance metrics are defined, tracked, and reported back to leadership teams Member of functional sub-teams to assure deliverables are completed on time, and dependency assessments are conducted regularly Responsible for the preparation of monthly status reports.
- Ensure that budgets are aligned with project progress – and that the release of funds is seamless if projects are on time, on budget and the business case still holds
- Set up stakeholders for success by providing detailed briefings and clear instructions
- Identify and escalate issues appropriately when launches are at risk of delay/ failure
- Act as the day-to-day owner of product development/ launch planning and delivery
- Act as a data warehouse for all key information the drives decision making and progress tracking (Business cases, key labelling and data files, stage gate progress, Gantt charts, etc.)
- Participate in control tower meetings facilitating discussions / actions on allocated products
- Provide timely, routine, project updates to the Executive Team
- Share best practice and insights with other cross functional participants
Qualifications and Requirements
- Bachelor’s degree in science, business or related field strongly preferred.
- Minimum 10 years’ experience in a project management leadership role within a pharmaceutical environment. This should include experience successfully managing multi-disciplinary teams as well as multiple projects. Strong grasp of product development concepts and processes. Demonstrated aptitude for effective leadership of staff.
- Minimum 10 years in a supervisory or leadership role with appropriate management level experience required.
- Certification in Project Management is highly preferred.
- Position requires organizational and planning skills as well as strong oral and written communications.
- Exceptional influencing and team development skills.
- Superior organizational skills, must be able to manage multiple projects with high priority.
- Strong Microsoft Project and Excel skills
- Ability to manage multi-disciplinary teams.
- Effective interpersonal, communication skills, both verbal and written.
- Solid presentation skills.
- Proficient in Project Management Software.
- Experience implementing Quality Management Systems is a plus.
- Travel up to 25%