Clinical OutsourcingClinical Trial Site AgreementsOncology
Useful technologies
ExcelWord
Required qualifications
Field of studyBusiness Administration, Life Sciences (or related)
Study levelBachelor's
Original posting
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
We are seeking an experienced and highly motivated Director to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in clinical outsourcing, site contract and budget negotiation, and managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations.
Role and Responsibilities:
Under minimal guidance, lead the 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 other necessary documentation. Knowledge of CTA legal risks and possible fallback language required.
Rigorous analysis of budgets with the goal of securing the best price
Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledgeable of all details
Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts
Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts
Provide regular updates to management on progress and key performance indicators related to trial agreements
Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns
Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes
Build and maintain strong relationships with CROs, FSP providers, and clinical sites
Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations
Identify and implement departmental processes or standards
Assist and work with senior management on special projects
Develop and maintain outsourcing strategies to support clinical trials across various phases
Ensure timely and cost-effective solutions that meet project timelines and budgets
Address and resolve any issues or disputes related to site agreements
Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development
Develop and implement new ideas and solutions to increase the efficiency of the department
All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
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
This is the pay for this position
Pay Transparency$203,000—$253,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Clinical Study Start-Up Director at Summit Therapeutics — BranchFactor