Associate Director, Program Management (Regulatory)
Posted on Oct 28, 2020 by Dollar Tree, Inc.
This position will be responsible for providing Project Management expertise and support to Nektar projects to ensure all project milestones and deliverables are met, and that activities are well executed and managed. Responsibilities include the day-to-day planning, coordinating and tracking of critical activities and information flow between team members, the project leader, and senior management. This position will be responsible for establishing and developing cross-functional teams to support the company's clinical study pipeline with particular emphasis on supporting regulatory filing efforts. The project manager will be responsible for driving the project timelines to keep the project on schedule and within budget and scope. Typical responsibilities also include: planning, facilitating, and following-up on regular project team meetings; anticipating and managing potential project issues, understanding the scope, schedule and resources for the project, and the utilization of Gantt charts and other project management tools to facilitate communication within the team, across the organization, and with external collaborators. This particular role will be primarily allocated to supporting the Global Filing Team (GFT) for the Biologics License Application (BLA)/Market Authorization Application (MAA) of our lead oncology compound, bempegaldesleukin, and may also include project management of clinical trials and other key cross-functional activities.
Essential/Primary Duties, Functions and Responsibilities
Partners with Global Filing Team Leader, Project Team or Study Team Leader to optimize team effectiveness and decision making, facilitate team building and communication.
Partners with counterpart in external alliance partner to ensure organizational and tactical alignment.
Creates and drives timelines to keep project(s) on schedule. Prepares project timelines (Gantt chart) identifying all significant activities, dependencies.
Develops and distributes agenda for team meetings. Helps facilitate meetings and keep them on track. Responsible for writing and providing meeting minutes, and driving follow up on action items.
Proactively, and independently, identifies and resolves project team challenges. Drives scenario planning in support of strategic decision making.
Directs cross-functional project team(s) and drives information compilation and information flow
Communicates project status to all stakeholders in collaboration with the Project Team or Study Team Leader.
Works with Program Management Leadership and team to define program-related budget assumptions for annual operating plan.
Maintains effective communication within project team through oral and written correspondence.
Creates and maintains easily accessible, high level project documents in electronic format.
Prepares information with appropriate input from team members for internal as well as external partner review/governance meetings.
Demonstrates problem solving and good judgment in which analysis of situations or data requires an in-depth evaluation of various factors.
Develops knowledge of current therapeutic environment and drug development trends as needed.
Contributes to the development of the Program Management Department through introduction of new tools and processes.
Responsible for establishing and developing cross-functional teams to support research and development process and may identify optimal opportunities for product.
Organizes interdepartmental activities ensuring completion of the project on the schedule and within budget constraints.
This job contributes to and supports the companys research and development efforts to create high value therapeutics to address unmet medical needs.
Ensures budgets, schedules and performance requirements are met.
Directs the decision making process within the team; suggests and implements alternatives to meet changing program goals; resolves team and program issues/conflicts through strategic planning and the application of project management best practices to ensure program objectives are met.
In cooperation with functional area managers, ensures that resources assigned to the program are adequate to meet program objectives and identifies resource constraints.
Makes recommendations as to whether program or project activities should be outsourced for greater resource efficiency.
Reviews and revises project work plans to accommodate changes in technical, marketing, or business objectives and communicates changes accordingly.
Participates in work related professional organizations and represents the Company in appropriate professional public forums.
Integrates scientific and business objectives to maximize program success. May manage other junior program management staff.
Other Duties as assigned.
Minimum of a BA/BS in a scientific discipline is required, while an advanced degree (PharmD, PhD, MS, MBA, MD) is desirable in a discipline related to drug development or business. Certification in Project Management is preferred. Continuing education in Project Management best practices is required. A minimum of 10 years experience in the Pharmaceutical, Medical Products or other related industry is required. A minimum of 8 years management experience is preferred. Prior experience in managing interdisciplinary or cross functional pharmaceutical or medical device product development teams is required. Prior experience in managing cross-functional teams through Regulatory Affairs projects and related key milestones is required. Specifically, experience in driving teams to BLA/MAA filings is strongly preferred. Experience across various oncology indications and multiple countries (Health Authorities) is desired. Oncology experience highly desirable. Previous experience working with corporate partners or acting as a liaison is required. Understanding of FDA regulatory processes and prior experience with regulatory filings is highly desired. Participation in an executive steering committee for pharmaceutical or medical device product development is required. A working knowledge of basic financial accounting is required. Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint and Project is required. Demonstrated ability to develop, manage and lead cross-functional teams. Ability to relate and work with wide range of people (internal and external) to achieve results Ability to drive project plan and timelines (across multiple functional areas) essential. Proven success in goal setting, prioritization and time management. Proactive individual with strong leadership, facilitation, teamwork and influence management/negotiation skills. Proven ability to proactively identify risks and drive resolution of issues Ability to work independently for decision-making and resolution of project obstacles and conflicts. Familiarity with developing budgets and forecasting desirable. Keen insight, independent judgment and tactful discretion are required. Business acumen a big plus. Ability to deal with ambiguity. Self-motivated, flexible and resilient. Commitment to professional development of oneself, team members and department. Must be able to demonstrate strong analytical and problem solving capabilities. Excellent oral and written communication skills are required. Must be able to demonstrate strong organizational skills.