HEAD OF CLINICAL OPERATIONS
High-Growth Biotech Start-Up · Confidential Search · Managed by TSE Executive Search
THE COMPANY
This is a rare opportunity to join a high-energy, first-in-class biotech at the ground level. The organization is built on a culture of scientific ambition, entrepreneurial urgency, and a genuine belief that the therapeutics they’re developing will matter for patients. If you’re energized by building — not maintaining — and you want your fingerprints on something that counts, read on.
THE OPPORTUNITY
As Head of Clinical Operations, you will own the operational engine of the company’s clinical development programs. This is a strategic leadership role with full accountability for all clinical trial operations across the portfolio — from site selection and CRO management through enrollment, data collection, and study close-out.
You will report to senior clinical leadership, build and lead the Study Management organization, and serve as the operational partner to Clinical Development, CMC, Regulatory, and Finance. You’ll be expected to think strategically, move with urgency, and hold the organization to a high bar — because in a start-up, every day and every dollar matters.
WHAT YOU WILL OWN
Clinical Operations Leadership
- Lead all operational and strategic aspects of global clinical development programs across the full portfolio
- Provide end-to-end oversight of clinical trial site management — site selection, CSAs, CRF design, study documentation, initiation, enrollment, monitoring, data collection, and reporting
- Drive timely, high-quality execution of clinical studies in full compliance with GCP guidelines and Clinical Development Plans
- Serve as the operational point of accountability for program-level execution and deliverables
CRO & Vendor Management
- Identify, select, and manage CROs, contractors, clinical operations consultants, and external vendors across studies and programs
- Contribute to and own the clinical operations resource strategy — ensuring the right external partnerships are in place to support program timelines and budgets
- Hold vendors to performance standards and escalate proactively when execution is at risk
Team Building & People Leadership
- Recruit, develop, and retain best-in-class Study Management staff across the portfolio
- Provide direct line management, mentorship, and functional leadership to all Clinical Operations staff
- Build a team culture that reflects the organization’s entrepreneurial spirit — fast, accountable, and mission-driven
Strategic Planning & Program Governance
- Contribute to scenario planning, high-level timeline forecasting, global feasibility assessments, and resource and budget allocation
- Develop and communicate budget, resource, risk, and timeline information to internal and external stakeholders with clarity and confidence
- Input into risk management plans, long-range planning, and business value assessments
- Bring therapeutic area and indication expertise to program-level strategic discussions
WHAT WE’RE LOOKING FOR
Required
- Bachelor’s degree in a Life Science or Business discipline (or equivalent); advanced degree a plus
- 10+ years of industry experience in clinical operations within pharma or biotech
- Minimum 4 years of project and line management experience
- Demonstrated track record leading and managing global Phase 1–4 clinical trials on time, within budget, and to the highest quality standards
- Extensive experience in CRO and vendor selection and management
- Strong working knowledge of ICH Guidelines, GCPs, and operational and regulatory requirements across multiple regions — US, EU, China, and Japan
- Strong financial acumen — experience managing and reporting on clinical program budgets
- Working knowledge of data management, data review and analysis, drug safety, and pharmacovigilance
- Ability to travel as required
The Right Person
- Thrives in a start-up environment — comfortable with ambiguity, energized by growth, and willing to roll up their sleeves when needed
- Operates at both the strategic and tactical level without losing sight of either
- Communicates with clarity and credibility to internal teams, external partners, and senior leadership
- Holds themselves and their team to exceptionally high standards — and creates a culture of accountability without creating a culture of fear
- Brings genuine passion for the mission — first-in-class therapeutics and the patients who need them
HOW TO APPLY
This search is managed exclusively by TSE Executive Search.
Please submit your resume and cover letter to:
jobs@tseworldwide.com
All applications are held in the strictest confidence.