Senior Director, Development Clinical Operations

Day One Biopharmaceuticals•Brisbane, CA

20d•$260,000 - $280,000•Hybrid

About The Position

SENIOR DIRECTOR, DEVELOPMENT CLINICAL OPERATIONS At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned. POSITION SUMMARY: The Senior Director, Development Clinical Operations provides strategic and operational leadership across Day One’s clinical development portfolio. This leader is accountable for translating development strategy into operational delivery — driving execution excellence across multiple programs and phases while fostering collaboration, innovation, and efficiency across the organization. Strong preference for candidates in the San Francisco Bay Area or Greater Boston area who can work a hybrid schedule with regular in-office days; however, remote opportunities may be considered. Domestic US travel up to 30%, and internationally up to 10% in support of trial activities.

Requirements

BS/BA degree in science-related discipline; or, Advanced degree in related discipline; or, Certification in assigned area.
12+ years plus of related experience, contingent on education/training.
Extensive clinical operations knowledge and cross-functional understanding of global clinical trial planning and execution
Experience with participating in and preparing for regulatory inspections
Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
Adept at addressing and solving challenges with complexity and ambiguity; ability to collect, digest and communicate information through relevant business analyses to influence decision-making.
Ability to communicate vertically and horizontally through multiple channels, leverage contact network to motivate diverse teams, and enable cross-functional collaboration.
Prior experience managing full-time and contract employees.
Works on assigned problems of complex scope with analysis of situation or data required.
Exercises judgment within defined procedures and practices to determine appropriate action.
Builds productive internal and external working relationships.
Uses professional concepts and company policies and procedures to solve a variety of routine problems.

Nice To Haves

Oncology and/or rare disease experience is preferred.

Responsibilities

Partner with clinical development leadership and cross-functional stakeholders, including program and study teams to develop and implement the operational strategy for the clinical portfolio, aligning with overall company objectives.
Translate asset strategy into operational plans, timelines, budgets and resource models across multiple programs.
Drive scenario planning, resource modeling, and risk mitigation at the program and portfolio levels.
Act as a key operational liaison across functions — clinical development, regulatory, medical affairs, safety/pharmacovigilance, supply chain, data management/biostatistics, business development — ensuring alignment and collaborative delivery of clinical assets.
Engage with senior stakeholders and serve as escalation point for operational issues impacting program and study timelines, quality or budget.
Influence portfolio decision-making through data-driven insights and operational risk/opportunity analysis.
Represent Development Operations in advisory and decision-making committees, governance committes, and external forums (i.e. investigator meetings, industry conferences) as applicable.
Oversee and ensure timely and high‐quality execution of global clinical trials (Phase I – IV as applicable), including site selection/start-up, enrollment, monitoring, data management, and close-out.
Lead outsroucing strategy, vendor/CRO selection, negotiation, scope development, oversight and performance management; ensure optimal resource allocation and vendor deliverables meet or exceed contract commitments and KPI targets.
Establish and monitor operational KPIs at study and portfolio levels in collaboration with Development Operations colleagues
Contributes to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents.
Champion process improvement and, innovation (e.g., decentralized models, digital enablement, automation), and operational consistency across studies and programs
Forecast, plan and manage resource needs (internal FTE and external vendors) for current and pipeline programs; contribute to capacity planning, budget development, and cost management
Lead, develop and inspire a high‐performing clinical operations organization; mentor team managers, foster continuous improvement culture, and champion innovation (e.g., trial design, digital tools, automation).
Ensures compliance with GCP/ICH, FDA/EMA regulatory requirements and corporate standards; leads and promotes inspection readiness.
Proactively identify and manage operational risks and opportunities across the portfolio, design mitigation/contingency plans, and adapt operations accordingly.
Partner with Quality to identify systemic operational gaps, shape CAPA strategies that address root causes, and drive sustainable process improvements that elevate clinical operations performance across programs.
May attend qualification, initiation, interim monitoring, monitoring oversight and close-out visits.
Ensures all trials are conducted in accordance with Standard Operating Procedures, established guidelines and work instructions, and ICH-GCP
Other duties as assigned.