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Day One Biopharmaceuticals · 2 hours ago

Senior Director, Development Clinical Operations

United States

Full-time

Remote

Director/Executive

$260K/yr - $280K/yr

12+ years exp

Day One Biopharmaceuticals is focused on advancing first- or best-in-class medicines for childhood and adult diseases. The Senior Director, Development Clinical Operations is responsible for providing strategic and operational leadership across the clinical development portfolio, ensuring execution excellence and collaboration across multiple programs and phases.

BiopharmaBiotechnologyHealth CarePharmaceutical

No H1B

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

Qualification

Clinical operations knowledgeOncology experienceRegulatory inspections experienceClinical Practice knowledgeTrial planning experienceRisk mitigation strategiesBudget developmentCross-functional collaborationTeam managementProblem-solving

Required

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