The Senior / Director-Executive Director, Program Management will support corporate goals and objectives by supporting execution of programs from Pre-IND planning through NDA approvals. S/he will be a key leader in actively managing highly technical, cross functional teams to ensure the execution of clinical development programs in a dynamic, collaborative environment. S/he will oversee and manage program related scope, timelines, budgets, deliverables, risks, decisions and action items, meeting planning, and communications. PM deliverables also include dashboards that allow cross functional teams, governance committees and the senior management team to quickly understand progress against goals, identification of interdependencies, and an assessment of risk, timelines, and cost.
Responsibilities include, but are not limited to:
• Develops and leads program management activities for high performing, cross functional program teams to manage the development and execution of corporate goals (including representatives from Research, Clinical, Translational, Regulatory, CMC, Nonclinical, Finance, and Commercial).
• Translates goals into detailed project tasks, properly sequenced, resourced and budgeted with estimated timeframes (Gantt charts) to key milestones.
• Provides continuous support for teams to proactively track and monitor project progress. Works with teams to identify criteria and metrics for decision making and support team in creating forums for presentation of new information, timely decision making and responsiveness.
• Establish best practices and benchmarks to measure performance and results against peers.
• Ensures all PM deliverables are fit-for-purpose, scalable and easy to understand for decision-making.
• Summarizes complex topics and relay information regarding project status, issues, decisions, etc. team members, senior leadership and staff as appropriate.
• Leads team through periodic risk identification and management process.
• Works with the program team members to facilitate project/program execution from Pre-IND planning through NDA/MAA approvals, utilizing project management tools and processes to maintain strategic direction, project schedule/timeline, communications, and identify and mitigate risks.
• Effectively communicates horizontally and vertically to ensure decisions are made at the right venue and understood by all stakeholders.• Facilitates program related decision-making processes by working with the program teams for proposals and resolutions and preparation for senior management review as part of the governance process.
• Manages and oversees program team meeting operations including planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items. Ensures program team activities and decisions are clearly communicated, documented, and archived.
• Ensures program-related documentation is maintained such as program plans, budgets, timelines, risk logs, dashboards, and project goals ensuring appropriate access.
• Works with project lead and sub team leaders to create a highly functional team environment.
• Interacts with support functions (legal, finance, strategy and operations) to ensure transparency alignment for programs.
• Identifies the need for and creates new PM Standard Operating Procedures (SOPs).
• Other duties as assigned
Position Requirements & Experience:
• BS/BA degree (MS, MBA, PhD and/or PMP certification preferred) in a relevant life science or related field
• 7+ years up to 15+ year of relevant hands-on pharmaceutical/biotech industry experience, managing cross-functional teams
• Strong understanding of the drug development lifecycle, and the strategic and operational requirements from pre-IND through NDA
• High level mastery in program management, managing clinical phase deliverables and timelines to ensure the program remains on schedule and within agreed to scope and budget
• Experience with cross-functional team roles and responsibilities in clinical stage drug development, with a track record of influencing and problem solving to find creative solutions to risks or issues that arise
• Experience working with project management methodologies including cross-functional project planning, budget development/accruals assessment, and project management software and visualization tools (Microsoft Project, SmartSheet, Office Timeline Pro, One Pager Pro, Think Cell, etc)
• Leadership skills, personal integrity and the ability to work effectivity with others in a fast paced environment is critical. Being comfortable working under ambiguity is required.
• Proficiency working with Microsoft Office programs (Word, PowerPoint, Excel, Outlook, Teams, OneNote, etc) and document storage/management systems (SharePoint, Box, Veeva Vault, etc)
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Proven ability to manage competing priorities in a fast-paced, rapid-growth environment
• Ability to work independently and collaboratively adapt as part of a team
• Strong interpersonal skills, including verbal and written communication• Candidates must be authorized to work in the U.S.
• Travel may be required up to 10%
Qualified candidates should email resume to jobs@tseworldwide.com