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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Program & Portfolio Leadership:

• 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.

Strategic Influence and Stakeholder Engagement:

• 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.

Operational Execution & Excellence:

• 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

Resource Planning & Organizational Leadership:

• 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).

Quality, Compliance & Risk Management:

• 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.

QUALIFICATIONS

• 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.
• Oncology and/or rare disease experience is preferred. required.
• 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.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $260,000 - $280,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.