Senior Director of Clinical Operations

The role

The Senior Director of Clinical Operations will take personal ownership of the clinical delivery for an in-licensed asset from start-up to close-out. This role involves managing clinical and regulatory execution, providing senior oversight for SOPs and quality, and mentoring the wider ClinOps team.

What you will do

• Own the delivery of the trial for one asset, accountable for clinical and regulatory execution, quality, and budget.
• Line-manage the Clinical Program Manager running the trial.
• Proactively spot and mitigate risks by contributing to the assets clinical development plan.
• Build clinical operations and regulatory capability for complex, FDA-facing trials.
• Input into ClinOps SOP and process design across the portfolio.
• Work with tech and product teams to input into tool and system design.
• Guide, mentor and support professional development of the wider ClinOps team.
• Act as senior authority on operational and quality decisions and sign-off across every trial in the LTx portfolio.

Required qualifications

• 15+ years in clinical operations, with genuine hands-on delivery across multiple Phase 2 drug trials.
• Real, first-hand experience making clinical, quality and safety judgement calls in real time across a range of trials.
• A track record of senior review and sign-off on essential trial documents - monitoring plans, RAMPs, protocol deviations, eTMF readiness.
• A proportionate, risk-based approach to clinical oversight.
• A track record of contributing to or leading SOP and process design at a portfolio or function level.
• Broad experience across trial types, phases and therapeutic areas.
• Comfortable shaping the tools you work in, including influencing how trial systems (EDC, CTMS, eTMF) get built.
• High agency and a bias for action.

Nice to have

• Experience across multiple regulatory jurisdictions, with FDA preferred
• Experience from both a CRO and Sponsor point of view

Benefits

• Competitive salary, plus meaningful stock options
• 27 days annual leave in addition to 11 National Holidays
• Health insurance coverage through our PEO Trinet
• $40 monthly wellness allowance
• Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
• $2,000 Learning and Development allowance each year
• Regular whole company and team events, both in person and virtually
• Access to gym and retail discounts through our benefits platform Happl
• Monthly lunch voucher for our remote teams
• Charity events and fundraising opportunities

Before you apply

• Initial conversation with Senior Talent Partner
• Second interview with VP Operations and others
• Functional Interview with CMO and head of Quality
• Values interview with 2 team members

About the company

Lindus Health is building the next generation of biopharma by in-licensing clinical-stage therapeutic assets and developing them through an integrated, technology-first clinical trial infrastructure.