Director, Clinical Study Start-Up

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $203k - $253k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Lead development of pricing strategies for site budgets to enable contract execution and site activation • Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards • Negotiate and finalize site agreements, including budgets, contracts and required documentation • Analyze budgets to secure the best price • Present budgets to the Chief Accounting Officer for approval • Provide study-wide site payment estimates and forecasts with Clinical Finance • Work with legal counsel on indemnification, liability and confidentiality provisions • Provide management updates on progress and trial-agreement KPIs • Address budget, invoice, payment and purchase-order concerns with Finance and Clinical Leadership • Collaborate with external FSP providers on budget templates, work orders, purchase orders and site payment processes • Build relationships with CROs, FSP providers and clinical sites • Monitor FSP providers’ timelines, quality standards and contractual obligations • Identify and implement departmental processes and standards • Assist senior management with special projects • Develop and maintain outsourcing strategies for clinical trials across phases • Deliver timely, cost-effective solutions within project timelines and budgets • Resolve site-agreement issues and disputes • Collaborate with Legal, Clinical Operations and Clinical Development • Develop and implement efficiency improvements • Perform other assigned duties

🎯 Requirements

• Bachelor’s degree in Life Sciences, Business Administration or related field required • A minimum of 10+ years’ experience with clinical trial site agreements in biotech or pharmaceutical setting • Experience in oncology is highly desirable • Strong global negotiation and contract management skills • Experience in clinical finance, business development, or clinical operations • Strong financial acumen and ability to understand and create budgets • Experience working with site budgets on a global scale, and potential internal escalation pathway • Strong knowledge of using grant plan • Expertise in large, multi-site, clinical trials with multiple vendor types is required • The ideal candidate will have experience working with departments that have established processes in place • Direct experience vetting and negotiating with sites and vendors is a must • Good understanding of the clinical process is important • Proficient user of standard MS Office suite (e.g., Word, Excel); experience using electronic document management systems and document review tools desirable • Strong computer and database skills • Attention to detail, accuracy and confidentiality • Clear and concise oral and written communication skills • Excellent communication, interpersonal and organizational skill • Critical thinking, problem solving, ability to work independently • Must be able to effectively multi-task and manage time-sensitive and highly confidential documents • Communicate effectively and articulate complex ideas in an easily understandable way • Prioritize conflicting demands • Work in a fast-paced, demanding and collaborative environment • Knowledge of GCP guidelines and relevant regulatory requirements

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Equal Opportunity Employer