Program Manager (Contractor - 9 mos)
About The Position
Provide strategic program management leadership beginning in early development to ensure preclinical plans, regulatory strategy, and operational activities are aligned to enable timely IND/CTA submissions and expeditious initiation of First-in-Human (FIH) studies. Facilitate development of early clinical strategies that inform and shape preclinical planning, ensuring research-level outputs and key documentation appropriately support IND/CTA submissions. Partner cross-functionally with Research, CMC, Preclinical, Clinical, Regulatory, and Commercial teams to develop and execute cross-functional program strategy and integrated long-range plans spanning early research and preclinical development through regulatory approval and commercialization. Drive team alignment and execution of the integrated program plan using strong Project and Program Management principles and best practices, including proactive management of stakeholders, timelines, risks/issues, budget, resources, and governance processes. Manage program reporting, escalate risks/issues to leadership, and highlight key milestones and team achievements to the broader organization.
Requirements
- BS/BA degree in Life Sciences discipline and 8+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry, including experience with both early and late phase pharmaceutical program management including IND/CTA, NDA/MAA submissions. Experience managing global drug development efforts
- Master’s degree in Life Sciences discipline and 6+ years of similar experience noted above
- PhD in Life Sciences discipline and 4+ years of similar experience noted above
- Experience as a PM on early and mid-phase global drug development programs including some of: early CMC & Preclinical alignment, understanding of pharmacology, DMPK, and translational strategy integration into early clinical planning, IND/CTA submissions, First-in-Human though Phase 2 clinical development and execution, end-of-phase 2 meetings
- Ability to lead cross-functional teams
- Ability to meet multiple deadlines across a variety of projects/programs
- Good leadership and mentorship skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture and longer-term impact on division/company
- Demonstrated knowledge of project management practices, tools and methodology
- Knowledge of the drug development process and inter-dependencies between key functions including research, CMC, non-clinical development, clinical development and operations, and regulatory affairs
- Ability to manage conflict, drive consensus, and promote decision-making
- Ability to independently identify and manage project objectives, timelines, budgets, providing formal and informal status updates to stakeholders as needed
- Ability to challenge assumptions
- Proficiency in Smartsheet, MS Project or other project management software
Nice To Haves
- PMP Certification highly desired
Responsibilities
- Partner cross-functionally with Development Team members to manage the development and execution of program strategy
- Provide strategic program management leadership in early development to align preclinical strategy, regulatory planning, and operational activities in support of IND/CTA readiness and timely initiation of First-in-Human (FIH) studies
- Establish and maintain functionally integrated program schedules in accordance with established structures to enable accurate project analyses, identification of critical path activities and areas of resource constraint
- Assess program risk and support mitigation planning and tracking
- Lead scenario planning efforts to prepare teams for differing outcomes at key milestones
- Identify and leverage inter-dependencies in short-, mid-, and long-term program plans and advise teams on areas of risk or possibilities to accelerate development
- Challenge assumptions and provide recommendations to improve processes and outcomes
- Facilitate and document meetings, cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership
- Develop relationships with key functional stakeholder groups and their leadership across the organization to support the execution of program goals
- Contribute to the development of the Program Management function through the introduction of new tools and/or processes
- Contribute to successful execution of Program Management department goals and activities
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
