Senior Director of Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Take full responsibility for the clinical delivery of a licensed asset, managing the trial from initiation to completion.

• Oversee the clinical and regulatory execution of the trial, ensuring quality and adherence to timelines and budgets.

• Collaborate closely with and manage the Clinical Program Manager who handles day-to-day trial operations.

• Proactively identify and mitigate risks by contributing to the asset’s clinical development strategy.

• Work in partnership with Programme Directors within the Corporate Development team.

• Develop clinical operations and regulatory expertise for more intricate, FDA-facing trials.

• Enhance monitoring, oversight, and quality standards throughout the Clinical Operations team.

• Assist in the design of ClinOps SOPs and processes across the portfolio alongside the Director of Quality.

• Collaborate with technology and product teams on Citrus and other clinical delivery tools and systems.

• Mentor and support the professional growth of the broader ClinOps team.

• Act as a senior authority for operational and quality decisions, providing sign-off across all trials in the portfolio.

• Authorize safety, trial design, proportionality, essential trial documentation, and quality-related matters.

• Collaborate with cross-functional leads to address and resolve issues.

• Report directly to the VP of Operations.

⛳️ Requirements

• Over 15 years of experience in clinical operations, with substantial hands-on involvement in multiple Phase 2 drug trials.

• Experience with complex neurology trials in chronic conditions, preferably in Parkinson’s disease.

• Proven experience making clinical, quality, and safety judgments in real-time across various trials.

• Established track record of senior review and approval of essential trial documents, including monitoring plans, RAMPs, protocol deviations, and eTMF readiness.

• Proportionate, risk-based approach to clinical oversight.

• Proven ability to contribute to or lead SOP and process design at a portfolio or functional level.

• Extensive experience across various trial types, phases, and therapeutic areas.

• Comfortable in shaping clinical trial systems, including EDC, CTMS, and eTMF.

• Experience in multiple regulatory jurisdictions is highly advantageous, with FDA experience preferred.

• Strong sense of agency and a bias for action.

• Passionate and curious about transforming healthcare operations and health treatment development.

• Interest in contributing to a high-growth, mission-driven, VC-funded startup environment.

🏝️ Benefits

• Competitive salary along with significant stock options.

• 27 days of annual leave in addition to 11 National Holidays.

• Health insurance coverage through our PEO Trinet.

• $40 monthly wellness allowance, which can be utilized for a wellhub membership or wellness activities and expenses of your choice!

• Enhanced parental leave: 16 weeks of full pay for the primary caregiver and 6 weeks of full pay for the secondary caregiver.

• $2,000 annual Learning and Development allowance for courses, certifications, and professional development.

• Regular company-wide and team events, both in-person and virtual.

• Access to gym and retail discounts via our benefits platform, Happl.

• Monthly lunch voucher for our remote teams.

• Opportunities for charity events and fundraising through our partnership with the Forward Trust.