Note: The job is a remote job and is open to candidates in USA. Tarsus Pharmaceuticals, Inc. is seeking a Manager II to lead program management for a late-stage drug development program. The role partners with program and development teams to drive cross-functional strategy, integrated planning, regulatory submission execution, and launch readiness.
Responsibilities
- Partner with the Program Team Lead and Development Core Team to develop and execute cross-functional program strategy and integrated development plans for a late-stage program
- Establish and maintain functionally integrated program timelines spanning clinical, regulatory, CMC/manufacturing, quality, nonclinical, medical affairs, and commercial activities to enable accurate program analyses, identify critical path activities, and surface resource constraints
- Lead cross-functional planning and coordination for pivotal (Phase 3) trial execution, database lock, and topline readout activities
- Drive integrated regulatory submission planning and execution (e.g., NDA/BLA/MAA) in close partnership with Regulatory Affairs, ensuring alignment of cross-functional deliverables to support on-time, high-quality filings
- Support launch readiness planning by coordinating cross-functionally across clinical development, regulatory, medical affairs, commercial, and supply chain/manufacturing
- Identify and assess program risks; develop, track, and drive mitigation and contingency plans, including maintenance of a program risk register
- Lead scenario planning efforts to prepare teams for differing outcomes at key milestones (e.g., pivotal readouts, regulatory interactions, launch)
- Challenge assumptions and provide recommendations to improve program processes, decision-making, and outcomes
- Facilitate and document Development Core Team and sub-team meetings, cross-functional communications, and governance decisions, ensuring alignment with internal functional groups and leadership
- Support program budget and resource planning in partnership with Finance and functional leads, tracking spend against forecast and flagging variances
- Develop strong relationships with key functional stakeholders and their leadership across the organization to support execution of program goals
- Serve as a Program Management subject matter expert and resource for the broader organization, championing program management best practices and continuous improvement
Skills
- Minimum 8+ years of product development experience in biotech or pharmaceutical settings, including at least 5+ years in a project/program management role
- Experience managing drug development programs from pre-clinical through Phase III studies is essential
- Bachelor's degree in a biopharmaceutical-related field (e.g., biology, chemistry, engineering) required
- Working knowledge of the end-to-end drug development process, including GxP/ICH guidelines and health authority interactions, for late-stage programs
- Ability to quickly and effectively pivot in response to changing priorities across programs and resources
- Proficient use of IT/project management tools (Outlook, Excel, PowerPoint, MS Project, Smartsheet, or similar)
- Established track record of effective people management, problem solving, collaboration, cross-functional leadership, and communication
- Excellent communication, influencing, stakeholder management, and decision-making skills
- Strong project/program management foundation
- Excellent communication and emotional intelligence to lead cross-functional stakeholders in achieving deliverables on time and within budget, with a demonstrated ability to implement effective processes and innovative solutions that improve program management efficiency
- Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there's not a blueprint for success. Owns their decisions and actions
- Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first
- Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met
- Direct experience supporting a program through pivotal trials, regulatory submission, and launch readiness
- Advanced degree
- PMP or PgMP certification
Benefits
- Onsite gym
- Onsite pool
- Snacks and drinks
- Occasional catered meals
- Hybrid work environment
- Remote work will be considered
- Bonus
- Stock equity
- Health, dental and vision insurance benefits
- Generous paid time off, including vacation, holidays, and personal days
Company Overview