The Senior Manager / Associate Director, Program Management will support strategy and 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 manage program related scope, timelines, budgets, deliverables, risks, decisions and action items, meeting planning, and communications.
Responsibilities include, but are not limited to:
- Leads program management activities for high performing, cross functional program teams to manage the development and execution of program strategy in alignment with corporate goals (including representatives from Research, Clinical, Translational, Regulatory, CMC, Nonclinical, Finance, and Commercial).
- Accountable as the primary contact for program team related information, and for obtaining and maintaining comprehensive knowledge of the program scope, deliverables, timelines, status, and key risks.
- 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.
- 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.
- Leverages input from all critical functions to prepare detailed integrated development plans that maximize the value of the programs. Defines the program’s critical path with program teams to understand the associated risks and to ensure the programs meet their milestones on time and on budget.
- Manages 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.
- Maintains program-related documentation such as program plans, budgets, timelines, risk logs, dashboards, and project goals ensuring appropriate access.
- Fosters strong relationships and supports effective, timely, and impactful communications with all stakeholders in order to ensure active management of issues, risks, decisions, opportunities, and planned changes to approved scope.
- Other duties as assigned
qualified candidates should email resume to jobs@tseworldwide.com
Position Requirements & Experience:
- BS, MS, or PhD in a relevant life science or related field, with at least 3-5 years of relevant hands-on pharmaceutical/biotech industry experience
- Strong understanding of the drug development lifecycle, and the strategic and operational requirements from pre-IND through NDA
- Demonstrated program management experience 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, Microsoft Visio, SmartSheet, Office Timeline Pro, One Pager Pro, Think Cell, etc)
- 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 and cover letter to jobs@tseworldwide.com