Associate Director/Director, Clinical Program Management
About The Position
Associate Director/Director, Clinical Program Management Skyhawk Therapeutics is seeking a Clinical Program Manager (Associate Director/Director level) to support the operational execution of clinical programs. The ideal candidate will ensure study activity alignment and financial oversight with overall program timelines and development objectives. This individual will work closely with Clinical Operations, Finance, Legal, and external partners to ensure clinical programs are delivered efficiently and within budget. This role will report to our VP of Clinical Operations. Skyhawk Therapeutics is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.
Requirements
- Bachelor’s degree in life sciences, clinical research, business, or related discipline
- 8–12+ years of experience in clinical operations, clinical program management, or clinical outsourcing within the pharmaceutical or biotech industry
- Experience managing cross-functional clinical trial execution and program timelines in outsourced clinical development models.
- Working knowledge clinical trial budgets, vendor invoicing, and financial tracking.
- Strong organizational and project management skills with the ability to manage multiple priorities across clinical programs.
- Proficient in Microsoft Office project suite (excel, word, MS Project, PowerPoint) and Share Point.
- Proficient in developing and managing Gantt charts for individual studies and overall program timelines.
Responsibilities
- Develop and manage integrated clinical program timelines, tracking key deliverables across Clinical Operations and external vendors.
- Coordinate planning and execution of key clinical milestones, including DSMB/DMC meetings, data cuts, interim analyses, and database locks.
- Ensure cross-functional readiness for data reviews, safety monitoring activities, and program governance meetings.
- In collaboration with the individual study leads, provide oversight of CROs, laboratories, and other vendors to ensure deliverables, timelines, and quality expectations support successful program execution.
- Partner with Legal and Finance on vendor contracts, scopes of work (SOWs), and change orders as needed.
- Monitor clinical study budgets and vendor spend against forecasts and yearly approved budgets.
- Review and track vendor invoices for accuracy and alignment with completed work against approved budgets.
- Contribute to the development of processes, tools, and best practices that support efficient clinical program execution in an outsourced development environment.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
