Description
Position Summary
Shasqi is hiring a Director, Clinical Operations to build and lead our clinical operations function for our oncology program. We’re looking for an individual who’s not afraid to get hands-on in the early days but is ready to spread their wings and help shape something much bigger as we grow. You will be the first hire shaping this function from the ground up, delivering high-quality, on-time, on-budget execution for a single Phase 1/2 study while designing it to scale across multiple programs. We are seeking a capable leader with the ability to deliver operational excellence and meet aggressive clinical milestones. The Director of Clinical Operations will report directly to the Chief Medical Officer (CMO).
Requirements
Required qualifications:
- 10+ years pharma/biotech experience, with 5+ years in oncology clinical operations (must include Phase 1 and 2 studies).
- Experience scaling ops from a first in class program to multiple programs in a biotech startup environment.
- Proven track record building and leading clinical ops teams, including direct hiring, mentoring, and performance management
- Hands-on experience leading global Phase 1/2 oncology studies end-to-end, from study startup to database lock
- Strategic thinker who translates vision into actionable plans and proactively mitigates risks- knows what can go wrong and how to proactively prepare for all possible outcomes.
- Strong vendor/CRO management: selection, oversight, issue resolution at executive level
- Expertise in financial planning, budgeting, forecasting, and resource allocation for clinical programs
- Advanced analytical skills; Excel/MS Project/Smartsheet expert for timelines, trackers, risk registers
- Highly organized, detail-oriented, autonomous yet collaborative
- Tech-savvy with passion for tools/processes driving efficiency
- Cross-functional leadership in matrixed organizations, influencing without authority
- Excellent communicator (written/verbal); comfortable presenting to C-suite/executives
Responsibilities including but not limited to the following:
- Lead operational delivery of Shasqi's lead oncology clinical program, ensuring on-time/on-budget execution while building scalable processes
- Serve as hands-on leader: roll up sleeves for critical tasks (study startup, site management, monitoring oversight)
- Build and scale clinical ops function: hire/ train first team members, establish SOPs, systems for growth
- Own clinical budgeting, forecasting, resource planning; achieve fiscal targets with <4% variance
- Select/manage CROs/vendors; negotiate contracts, oversee performance, resolve escalations
- Drive risk management, scenario planning, contingency strategies for study milestones
- Collaborate cross-functionally with others in the organization for integrated program success
- Provide strategic input to clinical development strategy; represent ops on leadership team
- Travel to sites as needed to meet with investigators, estimated 10% travel.
