Senior Director, Clinical Operations Business & Excellence

The Role:

Generate is seeking a Senior Director, Clinical Operations Business & Excellence to set the strategy for, establish, and lead a centralized Clinical Operations Business Office that embeds inspection readiness into clinical trial execution. This role will be accountable for the Business Office operating model, governance, and portfolio-level performance across that may include clinical sourcing and vendor governance, site contracts and budgets, trial master file operations, standard operating procedures, operational quality, monitoring oversight, risk and issue management, and corrective and preventive action (CAPA) follow-through. By establishing consistent metrics, processes, and clear accountability, the role will strengthen documentation traceability, enable timely identification and remediation of risks, and maintain sustained inspection readiness across the clinical portfolio.

Reporting into the head of Clinical Operations and partnering with development leadership and Quality, you will shape organizational inspection readiness. You will translate clinical portfolio priorities into scalable processes, clear accountabilities, and measurable improvements in quality, timeliness, and cost. In addition, you will anticipate the capabilities required as the portfolio evolves, recommend investment and resourcing priorities, and lead execution against agreed outcomes.

This role combines strategic judgment with hands-on execution and requires close collaboration across study teams, Clinical Development, Quality, Regulatory, Biometrics, Finance, Legal, Procurement, and technology partners. You will serve as a senior cross-functional leader, align stakeholders on complex operational decisions, and integrate commercial, financial, and quality insights into portfolio-level priorities. You will build the team capabilities, partnerships, and governance needed to scale the Business Office while enabling study teams to focus on advancing medicines for patients.

Here's how you will contribute:

Clinical Business Office & Financial Management

Set the strategy and lead the Business Office operating model. Define responsibilities, decision rights, service expectations, and handoffs with study teams. Own the Business Office roadmap, annual objectives, and performance measures. Lead resource and capability planning, including recommendations on internal capabilities and external service models, aligning priorities with clinical portfolio needs and reducing duplication across programs. Adjust the operating model as portfolio complexity and organizational needs evolve.

Vendor Governance & Site Contracting

· Be involved in commercial strategy and complex contracting decisions. Oversee and contribute to business negotiations for master service agreements, statements of work, and amendments in partnership with Legal, Procurement, and Finance. Establish clear deliverables, financial assumptions, performance expectations, and change-control practices within approved authorities. Set consistent negotiation and escalation practices, resolve material commercial issues, and evaluate cross-program implications of major commitments and changes.

· Own the centralized site contracting and budgeting operating model in partnership with service providers and internal teams. Oversee clinical trial agreement workflows, investigator budget templates, and negotiation practices to improve consistency, support appropriate site reimbursement, and accelerate study startup. Establish service expectations and performance measures, identify recurring bottlenecks, and lead cross-functional improvements that scale across the portfolio.

· Provide senior-level vendor governance and partnership leadership. Establish governance forums, key performance indicators, service expectations, and escalation pathways. Lead strategic business reviews and serve as a senior escalation point for material vendor performance issues. Drive recovery plans and recommendations on partnership continuation, expansion, or transition, engaging executive sponsors when decisions exceed delegated authority or carry significant portfolio implications.

Trial Master File & Continuous Inspection Readiness

· Own the electronic trial master file governance strategy and business process. Oversee eTMF structure, filing standards, document ownership, completeness, timeliness, and data integrity. Partner with Quality and technology teams on business requirements, access, retention, and reliable record retrieval. Establish portfolio-wide accountabilities and performance expectations, and prioritize process and system improvements based on risk and business needs.

· Lead a portfolio-wide approach to continuous inspection readiness. Establish risk-based TMF health checks and quality metrics, working with study teams and vendors to resolve gaps throughout study conduct and closeout. Provide development leadership with a consolidated view of readiness, recurring risks, and remediation progress, and drive cross-program action on systemic issues.

· Lead Business Office preparation and operational support for audits and inspections in partnership with Quality. Inform audit planning through operational

risk insights and coordinate Business Office participation in mock inspections and health authority inspections. Own delivery of Business Office remediation and CAPAs, including timely completion and assessment of effectiveness in partnership with Quality, while preserving Quality’s independent oversight and the independence of the audit function.

Risk-Based Quality Management, Process Improvement & Digital Enablement

· Set the Business Office approach to consistent, portfolio-wide risk-based quality management. Partner with study teams, Quality, and Biometrics to establish consistent risk assessment and review processes, including critical-to-quality factors, key risk indicators, and, where appropriate, trial-level quality tolerance limits. Integrate cross-study trends to identify systemic risks, establish escalation priorities, and drive preventive improvements while retaining study-level accountability for trial-specific decisions and execution.

· Establish and govern monitoring oversight standards. Define oversight standards for centralized, remote, and on-site monitoring activities. Use monitoring outcomes, emerging risks, and quality trends to drive timely action with study leaders and CROs. Evaluate the effectiveness of oversight practices across the portfolio and lead improvements in partnership with study leaders, without replacing their responsibility for study delivery.

· Own the operational standards framework and improvement roadmap. Lead the development, harmonization, adoption, and periodic evaluation of standard operating procedures, work instructions, job aids, and training in alignment with ICH-GCP, including E6(R3) as applicable, regulatory requirements, and company quality standards. Promote approaches proportionate to trial risks and avoid unnecessary operational complexity. Establish clear process ownership and change governance, and measure whether improvements are adopted and deliver the intended outcomes.

· Set and lead the Business Office digital enablement roadmap. Prioritize and oversee implementation of fit-for-purpose dashboards, analytics, and automation with technology partners, incorporating appropriate validation and data protection. Connect monitoring, TMF, and vendor performance insights to future sourcing decisions, contract terms, and process improvements. Develop business cases, sequence investments against portfolio priorities, and assess adoption and measurable operational value.

Leadership & Cross-Functional Collaboration

· Lead through strategic judgment, influence, and accountability. Serve as a senior Clinical Operations partner in cross-functional governance forums. Make decisions within delegated authority, resolve complex issues with cross-program implications, and align stakeholders on competing priorities. Bring senior leadership clear recommendations on material risks, investment decisions, and resource tradeoffs, with defined options, implications, and accountable next steps.

· Build organizational capability and leadership depth. Define the capabilities and team structure needed to deliver the Business Office strategy and recommend workforce plans aligned with approved priorities and resources. Set clear goals and

performance expectations for team members and matrixed contributors. Coach and develop talent, strengthen delegation and accountability, and build succession and knowledge-transfer plans for critical capabilities.

· Build a high-performing, inclusive team environment. Model accountability, transparency, empathy, and urgency. Encourage courageous communication, early escalation, and continuous learning, and lead cross-functional change with clear sponsorship, stakeholder alignment, and sustained adoption. Foster adaptability and resilience while maintaining focus on agreed priorities and outcomes

The Ideal Candidate will have:

· BSc in a scientific, business, healthcare, or related discipline. An advanced degree, such as an MBA, MS, PhD, or PharmD, is preferred.

·12 or more years of progressively responsible experience in clinical operations, clinical business operations, or related functions within biotechnology or pharmaceutical organizations, including sustained leadership of complex clinical operations capabilities, teams, or vendor delivery models across multiple programs. Demonstrated scope, leadership impact, and results will be considered alongside years of experience.

· Experience with Inspection Preparation for pivotal programs and developing team capabilities to be inspection ready at all times.

· Demonstrated expertise in clinical sourcing, CRO and vendor governance, contract negotiation, and investigator site budgeting, with the ability to balance quality, delivery, cost, and partnership considerations. Experience setting sourcing and governance strategy, leading complex negotiations, and resolving material partner-performance issues.

· Experience with eTMF governance, inspection readiness, and clinical quality processes, including strong working knowledge of ICH-GCP and practical application of risk-based quality management. Demonstrated ability to establish consistent standards across programs, identify systemic risks, and lead sustainable operational remediation in partnership with Quality.

· A track record of defining functional strategy, building scalable operating models, and delivering measurable results across multiple programs. Demonstrated ability to influence senior internal and external stakeholders, navigate ambiguity, resolve competing priorities, and exercise sound judgment on decisions with portfolio-level implications.

· Demonstrated success leading and developing senior professionals and matrixed teams, strengthening leadership capability, and driving sustained process and organizational change. Experience establishing clear accountabilities and building collaborative relationships across functions. Clear communication, active listening, and the ability to navigate difficult conversations with candor and empathy are essential.

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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

 

 

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