Associate Director, Clinical Study Start-Up

This position will be on-site in one of the following locations: Dallas, TX / Miami, FL / Princeton, NJ

*Relocation support will be considered for this role

Overview of Role

:We are seeking an experienced and highly motivated Associate 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 activatio
• nCollaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standard
• sNegotiate 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 pric
• eConfidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledgeable of all detail
• sPartner with Clinical Finance team to provide study-wide site payment estimates and forecast
• sWork with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contract
• sProvide regular updates to management on progress and key performance indicators related to trial agreement
• sWork with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concern
• sCollaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processe
• sBuild and maintain strong relationships with CROs, FSP providers, and clinical site
• sMonitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligation
• sIdentify and implement departmental processes or standard
• sAssist and work with senior management on special project
• sDevelop and maintain outsourcing strategies to support clinical trials across various phase
• sEnsure timely and cost-effective solutions that meet project timelines and budget
• sAddress and resolve any issues or disputes related to site agreement
• sCollaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Developmen
• tDevelop and implement new ideas and solutions to increase the efficiency of the departmen
• tAll other duties as assigne

dExperience, Education and Specialized Knowledge and Skills

• :Bachelor’s degree in Life Sciences, Business Administration or related field require
• dA minimum of 8 years’ experience with clinical trial site agreements in biotech or pharmaceutical settin
• gExperience in oncology is highly desirabl
• eStrong global negotiation and contract management skill
• sExperience in clinical finance, business development, or clinical operation
• sStrong financial acumen and ability to understand and create budget
• sExperience working with site budgets on a global scale, and potential internal escalation pathwa
• yStrong knowledge of using grant pla
• nExpertise in large, multi-site, clinical trials with multiple vendor types is require
• dThe ideal candidate will have experience working with departments that have established processes in plac
• eDirect experience vetting and negotiating with sites and vendors is a mus
• tGood understanding of the clinical process is importan
• tProficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirabl
• eStrong computer and database skill
• sAttention to detail, accuracy and confidentialit
• yClear and concise oral and written communication skill
• sExcellent communication, interpersonal and organizational skil
• lCritical thinking, problem solving, ability to work independentl
• yMust be able to effectively multi-task and manage time-sensitive and highly confidential document
• sCommunicate effectively and articulate complex ideas in an easily understandable wa
• yPrioritize conflicting demand
• sWork in a fast-paced, demanding and collaborative environmen
• tKnowledge of GCP guidelines and relevant regulatory requirement

s
The pay range for this role is $168,000 to $198,000 annually. 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 compensatio

n.
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