Description

Reporting directly to the Chief Medical Officer (CMO), the Senior Director of Clinical Operations will serve as the company’s senior operational leader responsible for all aspects of clinical trial planning, execution, oversight, and delivery. This is a pivotal leadership role for an experienced clinical operations executive who excels in lean, resource-constrained biotech environments and has a demonstrated track record of advancing oncology programs from first-in-human studies through late-phase development.

 The ideal candidate brings deep expertise in solid tumor oncology trials, has successfully led operations across the US and, preferably, Australian and APAC (South Korea, Taiwan) clinical environments, and is adept at managing complex multi-CRO and vendor ecosystems with minimal internal infrastructure. Comfort with AI-enabled clinical trial tools is a valued differentiator.

 Note on level: This role is scoped at the Senior Director level. Candidates should bring functional depth and hands-on execution capability alongside strategic leadership — the expectation is that this individual is both architect and operator in a lean sponsor environment.

Requirements

Key Responsibilities
Trial Planning & Execution

• Lead all clinical trial operations from pre-IND planning through FIH execution and beyond, including site feasibility, country selection, study startup, enrollment strategy, and operational risk management across the US and APAC (Australia, South Korea, Taiwan).
• Develop and maintain integrated study timelines, milestone trackers, and escalation frameworks aligned to corporate objectives.
• Partner with the CMO and medical team on protocol design review, operational feasibility assessments, and scenario planning for dose escalation decisions.

CRO & Vendor Governance

•  Serve as the primary company liaison to CROs, central labs, IRT/RTSM, EDC vendors, and specialty service providers.
• Lead RFP processes, bid defenses, contract negotiations, and Statement of Work reviews; hold all vendors accountable to agreed KPIs, milestones, and quality standards.
• Implement structured governance models including joint operating committees, escalation paths, and performance dashboards.

Infrastructure & Compliance

• Establish and maintain clinical operations infrastructure: SOPs, monitoring plans (risk-based and on-site), eTMF setup and inspection readiness, and quality oversight frameworks.
• Ensure GCP compliance in accordance with FDA regulations (21 CFR Parts 312, 50, 56), ICH E6(R3), and applicable international guidelines (TGA, MFDS, TFDA).
• Own TMF health and proactively address gaps in advance of potential regulatory inspections.

Cross-Functional Partnership

• Collaborate closely with regulatory affairs on IND/CTA submissions, protocol amendments, and country-specific regulatory strategies.
•    Partner with biostatistics and data management on eCRF design, data review plans, and database lock timelines.
•    Provide operational input to translational science and pharmacology teams on correlative sample logistics and PK/PD planning.

Budget & Resource Management
 

• Own the clinical operations budget; manage CRO/vendor accruals and deliver accurate budget-vs.-actual reporting in partnership with Finance.
• Build and manage a flexible network of FSPs, contractors, and consultants scaled to evolving trial needs; avoid over-hiring ahead of program milestones.

Technology & Innovation

• Evaluate and champion AI-enabled clinical tools (site selection analytics, patient recruitment modeling, central monitoring platforms, automated data review) as part of the company’s technology strategy.
• Serve as internal champion for eClinical platform adoption and optimization.

 Required Qualifications

• 12+ years of clinical operations experience in biopharma/biotech, with at least 5 years in a Director-level or above leadership role at a sponsor organization.
•    Substantial solid tumor oncology experience, including hands-on management of Phase 1/FIH dose escalation and dose expansion trials.
•    Demonstrated expertise managing end-to-end CRO relationships in a lean, predominantly outsourced sponsor model — including budget oversight, governance, and performance management.
•    Deep working knowledge of FDA IND regulations (21 CFR Parts 312, 50, 56) and ICH E6(R3) GCP guidelines.
•    Proficiency with eClinical platforms (e.g., Veeva Vault eTMF/CTMS, Medidata Rave, or equivalent EDC/CTMS systems).
•    Bachelor’s degree in life sciences or health-related field; advanced degree (MS, PharmD, PhD, or equivalent) strongly preferred.
•    Demonstrated ability to operate independently and make sound operational decisions with limited internal support infrastructure.

 Preferred Qualifications

• Clinical trial experience in Australia (TGA CTN/CTA framework) and/or APAC markets including South Korea (MFDS) and Taiwan (TFDA).
•    Experience building clinical operations infrastructure at a pre-Phase 1 or pre-IND stage company, including first-SOP and first-eTMF build.
•    Familiarity with AI-powered clinical operations tools (AI-assisted site selection, NLP-driven data review, predictive enrollment analytics).
•    Prior experience as the sole or lead clinical operations hire at a early-stage biotech.
•    PMP, RAC, ACRP, or SOCRA certification.