[Hiring] Senior Director, Clinical Operations Business & Excellence @Generate Biomedicines

Role Description

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
• 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.

Qualifications

• 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.
• 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.
• Experience with eTMF governance, inspection readiness, and clinical quality processes, including strong working knowledge of ICH-GCP.
• A track record of defining functional strategy, building scalable operating models, and delivering measurable results across multiple programs.
• Demonstrated success leading and developing senior professionals and matrixed teams.

Requirements

• Set the strategy and lead the Business Office operating model.
• Own the Business Office roadmap, annual objectives, and performance measures.
• Lead resource and capability planning, including recommendations on internal capabilities and external service models.
• Oversee and contribute to business negotiations for master service agreements, statements of work, and amendments.
• Own the centralized site contracting and budgeting operating model.
• Provide senior-level vendor governance and partnership leadership.
• Own the electronic trial master file governance strategy and business process.
• Lead a portfolio-wide approach to continuous inspection readiness.
• Set the Business Office approach to consistent, portfolio-wide risk-based quality management.
• Establish and govern monitoring oversight standards.
• Own the operational standards framework and improvement roadmap.
• Set and lead the Business Office digital enablement roadmap.
• Lead through strategic judgment, influence, and accountability.
• Build organizational capability and leadership depth.
• Build a high-performing, inclusive team environment.

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Company Description

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.