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Director, Clinical Study Start-Up
Summit Therapeutics, Inc.. Lead development of pricing strategies for site budgets to enable contract execution and site activation .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing pricing strategies and managing clinical trial site agreements, with a strong focus on negotiation, budget analysis, and compliance with regulatory standards. Proven ability to collaborate across departments and deliver efficient solutions in a fast-paced environment.
Highest-signal resume keywords
Clinical Trial Site AgreementsGlobal Negotiation SkillsBudget AnalysisClinical Finance ExperienceKnowledge of GCP Guidelines
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Budget ManagementContract ManagementClinical OperationsFinancial AcumenMulti-Site Clinical TrialsGrant Plan UsageRegulatory ComplianceOncology ExperienceDocument Management SystemsDatabase Skills
Soft Skills
Attention to DetailClear CommunicationCritical ThinkingProblem SolvingInterpersonal Skills
Tools & Technologies
MS Office SuiteElectronic Document Management Systems
Industry Keywords
BiotechPharmaceuticalClinical TrialsCROFSP Providers
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package
- Equal Opportunity Employer