Essential Functions and Responsibilities
Smartsheet Implementation & Administration
- Serve as the internal Smartsheet subject matter expert and primary administrator.
- Lead implementation, configuration, and optimization of Smartsheet across Program Management, Clinical Operations, CMC, and other development functions.
- Design, build, and maintain project plan templates, dashboards, reports, and automated workflows.
- Drive standardization of project planning processes and reporting methodologies across programs.
- Design, build, and optimize automated reporting systems for program and clinical study metrics.
- Provide training, support, and best practices to end users.
Project Planning & Timeline Management
- Develop, maintain, and continuously improve integrated cross-functional project plans.
- Partner with Program Management, Clinical Operations, Regulatory Affairs, CMC, Translational Sciences, and other teams to ensure timelines reflect strategies, deliverables, dependencies, and milestones.
- Monitor critical path activities, identify schedule risks, and proactively escalate potential timeline impacts.
- Support planning/execution for regulatory submissions, including IND-enabling activities and IND submissions.
Program Operations Support
- Support program teams through meeting coordination, action item tracking, risk management, and milestone monitoring.
- Contribute to continuous improvement of project management tools, processes, and governance practices.
- Provide operational support for candidate nomination, IND planning, and early clinical development.
- Support alliance and partnership activities, as applicable.
Qualifications
- Bachelorβs degree in life sciences, scientific, engineering, or related field.
- 5+ years of project management/program operations/clinical operations/regulatory operations experience in biotech/pharma drug development.
- Demonstrated experience with oncology and/or autoimmune development programs.
- Hands-on experience supporting IND submissions and early-stage drug development.
Skills/Abilities
- Advanced Smartsheet expertise (implementation, customization, workflow automation, dashboards, project plan development).
- Experience building/maintaining integrated cross-functional development timelines.
- Strong understanding of Regulatory, Clinical Operations, CMC, and Translational drug development processes.
- Excellent organization, communication, and stakeholder management skills.
- Ability to thrive in a fast-paced biotech environment.
Benefits (as stated)
- Base salary: $132,000β$147,000/year; stock options, restricted stock units, stock purchase plan (ESPP), and target bonus; comprehensive medical/dental/vision and supplemental disability insurance; relocation assistance may be available; annual bonus program; incentive stock option plan; 401k with flat non-elective employer contribution; HSA/FSA; unlimited PTO; generous holiday schedule (summer/winter shutdown).