Senior Director, Clinical Operations – Business & Excellence

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🔥 3 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $219k - $329k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Set the strategy for, establish, and lead a centralized Clinical Operations Business Office • Embed inspection readiness into clinical trial execution • Own the Business Office operating model, governance, roadmap, annual objectives, and performance measures • Lead resource and capability planning and recommend internal capabilities and external service models • Oversee clinical sourcing, vendor governance, site contracts and budgets, trial master file operations, standard operating procedures, operational quality, monitoring oversight, risk and issue management, and CAPA follow-through • Lead commercial strategy, complex contracting decisions, negotiations, and escalation practices with Legal, Procurement, and Finance • Own centralized site contracting and budgeting operations and improve study startup consistency and speed • Establish vendor governance forums, KPIs, service expectations, escalation pathways, and recovery plans • Own eTMF governance, filing standards, document ownership, completeness, timeliness, data integrity, access, retention, and record retrieval • Lead continuous inspection readiness, TMF health checks, quality metrics, audits, mock inspections, health authority inspections, remediation, and CAPAs • Establish portfolio-wide risk-based quality management, critical-to-quality factors, key risk indicators, and trial-level quality tolerance limits • Govern monitoring oversight standards for centralized, remote, and on-site monitoring • Lead development and harmonization of SOPs, work instructions, job aids, training, and process-change governance aligned with ICH-GCP and regulatory requirements • Lead the digital enablement roadmap, including dashboards, analytics, automation, validation, data protection, business cases, and investment sequencing • Serve as a senior cross-functional leader across Clinical Development, Quality, Regulatory, Biometrics, Finance, Legal, Procurement, technology partners, study teams, and vendors • Build organizational capability, define team structures and workforce plans, coach and develop talent, and establish succession and knowledge-transfer plans • Foster an inclusive, accountable, transparent, empathetic, and high-performing team environment

🎯 Requirements

• BSc in a scientific, business, healthcare, or related discipline • 12 or more years of progressively responsible experience in clinical operations, clinical business operations, or related functions within biotechnology or pharmaceutical organizations • Sustained leadership of complex clinical operations capabilities, teams, or vendor delivery models across multiple programs • Experience with inspection preparation for pivotal programs and developing team capabilities to be inspection ready at all times • Expertise in clinical sourcing, CRO and vendor governance, contract negotiation, and investigator site budgeting • 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 • Strong working knowledge of ICH-GCP and practical application of risk-based quality management • Ability to establish consistent standards across programs, identify systemic risks, and lead sustainable operational remediation in partnership with Quality • Track record of defining functional strategy, building scalable operating models, and delivering measurable results across multiple programs • Ability to influence senior internal and external stakeholders, navigate ambiguity, resolve competing priorities, and exercise sound judgment on portfolio-level decisions • Success leading and developing senior professionals and matrixed teams, strengthening leadership capability, and driving sustained process and organizational change • Clear communication, active listening, and ability to navigate difficult conversations with candor and empathy • Advanced degree such as MBA, MS, PhD, or PharmD preferred

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package • Equal employment opportunity

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