Summit Therapeutics, Inc. एक बायोफार्मास्यूटिकल ऑन्कोलॉजी कंपनी है, जो गंभीर और अभी तक पूरी तरह से पूरी न हुई चिकित्सा आवश्यकताओं के लिए दवाएँ विकसित और व्यावसायीकृत करती है। इसका प्रमुख कार्यक्रम, इवोनेसिमैब (SMT112), PD-1 और VEGF को लक्षित करने वाली एक द्विविशिष्ट एंटीबॉडी है, जिसका Akeso से प्राप्त लाइसेंस के तहत गैर-लघु कोशिका फेफड़े के कैंसर और अन्य ठोस ट्यूमर के लिए तीसरे चरण के नैदानिक परीक्षणों में मूल्यांकन किया जा रहा है। कंपनी का कार्य अपने लाइसेंस प्राप्त क्षेत्रों में नैदानिक विकास, नियामक रणनीति और संभावित व्यावसायीकरण तक फैला हुआ है, जिसमें मरीजों और उनकी देखभाल करने वालों की सहायता के लिए बनाए गए उपचारों पर ध्यान केंद्रित किया जाता है।
Director of Clinical Study Start-Up (United States Remote)
Lead site-agreement strategy, budgeting, negotiations, and payment forecasting for Summit Therapeutics’ global oncology trials. Drive compliant, efficient clinical-site activation and vendor coordination across study programs.
विवरण
- Develop site-budget pricing strategies that support contract execution and clinical-site activation
- Partner with Legal, Finance, CROs, and clinical teams to ensure site agreements meet regulatory and company standards
- Negotiate and execute site agreements, including budgets, contracts, and supporting documentation
- Review budgets to achieve favorable pricing
- Present proposed budgets to the Chief Accounting Officer for approval
- Prepare study-wide site-payment estimates and forecasts with Clinical Finance
- Coordinate with legal counsel on indemnification, liability, and confidentiality terms
- Report progress and trial-agreement KPIs to management
- Resolve budget, invoice, payment, and purchase-order matters with Finance and Clinical Leadership
- Coordinate with external FSP providers on budget templates, work orders, purchase orders, and site-payment processes
- Build effective working relationships with CROs, FSP providers, and clinical sites
- Track FSP providers’ timelines, quality standards, and contractual commitments
- Establish and implement departmental processes and standards
- Support senior management on special projects
- Create and maintain clinical-trial outsourcing strategies across development phases
- Deliver timely, cost-effective solutions within approved timelines and budgets
- Resolve site-agreement issues and disputes
- Work cross-functionally with Legal, Clinical Operations, and Clinical Development
- Design and implement process-efficiency improvements
- Complete other assigned responsibilities
आवश्यकताएँ
- Bachelor’s degree in Life Sciences, Business Administration, or a related discipline is required
- At least 10 years of experience managing clinical-trial site agreements in a biotechnology or pharmaceutical environment
- Oncology experience is highly desirable
- Demonstrated strength in global negotiation and contract management
- Experience in clinical finance, business development, or clinical operations
- Strong financial judgment with the ability to understand and develop budgets
- Experience managing global site budgets and navigating potential internal escalation pathways
- Strong working knowledge of grant plans
- Experience supporting large, multisite clinical trials involving multiple vendor types
- Experience working with departments that have established processes
- Direct experience evaluating and negotiating with clinical sites and vendors
- Sound understanding of clinical-trial processes
- Proficiency with standard Microsoft Office applications, including Word and Excel; experience with electronic document-management and document-review systems is desirable
- Strong computer and database skills
- High level of attention to detail, accuracy, and confidentiality
- Clear, concise verbal and written communication skills
- Excellent communication, interpersonal, and organizational abilities
- Critical-thinking and problem-solving skills, with the ability to work independently
- Ability to manage multiple priorities and time-sensitive, highly confidential documents effectively
- Ability to explain complex ideas clearly and understandably
- Ability to prioritize competing demands
- Ability to succeed in a fast-paced, demanding, collaborative environment
- Knowledge of Good Clinical Practice guidelines and applicable regulatory requirements
लाभ
- The total compensation package may include a bonus, equity, benefits, and/or other applicable variable compensation
- Summit Therapeutics, Inc. is an Equal Opportunity Employer