Associate Director, Clinical Business Operations – Clinical Outsourcing

🔥 44 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $150k - $200k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Encoded Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Encoded Therapeutics Inc. is a biotechnology company focused on developing innovative genetic medicines to address central nervous system (CNS) disorders. Their work aims to tackle the root causes of these disorders, providing potentially transformative, long-lasting therapies designed to improve patient outcomes and quality of life, particularly for conditions such as Dravet Syndrome and Angelman Syndrome. The company uses a unique targeting and regulation platform allowing for increased gene specificity and cell selectivity, overcoming challenges associated with first-generation gene therapies. Encoded Therapeutics is dedicated to translating cutting-edge science into practical, life-changing solutions for patients worldwide.

📋 Description

• Partner with clinical operations, data management, and biometrics teams to author Request for Proposals (RFPs) and define vendor scopes of work. • Lead cross-functional bid defense meetings, analyze commercial proposals, perform cost benchmarking, and provide data-driven recommendations to leadership. • Drive the strategic selection of CROs and specialized clinical vendors, optimizing the vendor portfolio for quality, scalability, and cost-efficiency. • Partner with Legal and the clinical development team in the drafting, negotiation, and final execution of Master Services Agreements (MSAs), Statements of Work (SOWs), Change Orders and confidentiality agreements across clinical functions. • Design, author, and standardize SOW templates to streamline vendor onboarding, establish baseline metrics, and reduce execution cycle times. • Manage the negotiation and execution of Clinical Trial Agreements (CTAs) and investigator budgets for sponsor-managed sites, ensuring rapid study startup. • Manage an active change order management pipeline to rigorously track contract amendments, budget shifts, and vendor performance. • Partner closely with study teams to proactively identify operational deviations from the original SOW, mitigating scope creep before it impacts the budget. • Liaise between Clinical Operations and Corporate Finance to ensure financial alignment across all programs. • Partner with the Head of Clinical Operations to build robust, multi-year clinical trial budget forecasts, lifecycle cost models, and annual operational plans. • Support quarterly Budget vs. Actual (BVA) reviews; track investigator grant accruals and vendor pass-through costs, and accurately explain financial variances to leadership. • Identify operational gaps and implement scalable business processes, tools, templates, and governance mechanisms to improve efficiency, transparency, compliance, and organizational effectiveness. • Support due diligence, alliance management, and business development activities as needed. • Champion a culture of accountability, operational rigor, collaboration, and continuous improvement across the Clinical organization.

🎯 Requirements

• Bachelor’s degree in life sciences, business, healthcare administration, finance, or related discipline required. • 7-9+ years of biotechnology, pharmaceutical, or life sciences experience with a heavy emphasis leading clinical outsourcing, clinical finance, or clinical business operations. • Demonstrated experience in clinical budgeting, forecasting (LRP) and vendor financial management. • Experience supporting clinical programs in rare disease, neurology, oncology, cell therapy, gene therapy, or advanced therapeutics strongly preferred. • Strong understanding of clinical development processes, CRO/vendor management models, portfolio planning, and GxP-regulated environments. • Proven ability to influence across functions and operate effectively with senior leadership in a dynamic, matrixed organization. • Excellent analytical, financial, organizational, project management, and problem-solving capabilities. • Exceptional communication and executive presentation skills, with the ability to translate complex operational and financial information into actionable insights.

🏖️ Benefits

• Comprehensive benefits package, including competitive employer premium contributions • Meaningful stock option grants • PTO, sick time and holiday pay • Generous Parental Leave program • Pre-tax medical and dependent care programs • STD, LTD, Life and AD&D • Professional development opportunities • Team-building events • Fully stocked micro - kitchen • Fitness center at South San Francisco location