Associate Director, Clinical Outsourcing

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors recently completing a second financing round to support clinical development of our lead assets. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.#LIHybrid.com.

SUMMARY

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors recently completing a second financing round to support clinical development of our lead assets. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. This is a hybrid role that will require 3 days in the office (2 core days and 1 flex day). #LIHybrid

POSITION SUMMARY

Reporting to the Sr. Dir., Clinical Outsourcing, this position will be responsible as required for supervising staff in the Clinical Outsourcing group. This position will work with internal teams (e.g. Clinical Development, Clinical Science, Legal, Finance and Procurement Departments) to establish excellent working relationships and provide support and assistance in the selection of clinical study vendors (i.e. CROs, Labs, Imaging, RTMS/IRT, Clinical Sites, etc.), negotiation of contracts/budgets and help to manage vendor relationships. Must possess excellent communication and managerial skills and will be responsible for vendor governance and relationship strategies, vendor selection and budget process improvement, benchmarking and industry assessments, and be one of the key points of contact for issue escalation and resolution. This is an individual contributor role.  This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).s.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Will be responsible for developing/updating new and current SOPs and other Outsourcing processes, forms and templates.
• Assist with market intelligence research.
• Lead vendor evaluation activities (RFIs and RFPs) and selection process including facilitation of vendor capability presentations, software demonstrations, bid defense meetings and vendor award notifications.
• Lead vendor contracting process in collaboration with key internal and external stakeholders, including scopes of work, budgets, and payment schedules and out of scope management; revision (increases, decreases), and close-out; contract and budget lifecycle activities.
• Effectively manage and balance vendor costs, quality, timelines, and risks throughout the lifecycle of vendor scopes of work, budgets and contracts.
• Represent Clinical Outsourcing at internal Team meetings.
• Build, maintain and grow business relationships with current and prospective vendors through honesty, integrity, and trust.
• Support vendor governance activities.
• Liaise and partner with Structure’s Legal department to ensure timely execution of vendor Confidential Disclosure Agreements, Master Services Agreements, Services Agreements, Work Orders/Task Orders, Amendments, Change Orders, Completion of Service Letters, Termination Letters and other types of contracts.
• Liaise and partner with Structure’s Legal and Finance departments to ensure vendor contract terms and conditions adequately address all business needs and requirements for services and protect Structure’s interests prior to contract execution.
• Liaise and collaborate with Financial Operations, FP&A, and other functional areas as needed to perform internal monthly vendor financial accruals, and internal financial forecasts.
• Partner and collaborate with Financial Operations function where needed on internal vendor invoice review and approval process.
• Supports project teams in the resolution of vendor performance issues
• Other duties and responsibilities, as assigned.
• May include occasional travel to current and/or prospective vendor facilities

Knowledge, Skills, and Abilities:

• Very knowledgeable about the Clinical Trial Process and various key players involved in running clinical trials.
• Applies judgment and professional expertise independently
• Understand line management function
• Able to prioritize and handle multiple tasks simultaneously
• Prior management/supervisory experience
• Must have demonstrated expertise in relevant clinical outsourcing activities
• Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
• Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
• In-depth knowledge of ICH/GCP guidelines and FDA regulations
• Proven experience in managing all levels of key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into process improvements as appropriate.
• Excellent computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.
• Embrace Structure’s core values.

REQUIREMENTS

Education

• BA/BS in a Scientific, Business or Legal discipline, or related field; graduate degree a plus.

Experience

• 6-9 years of Biotech, Pharmaceutical, or CRO Outsourcing experience or relevant experience.
• Excellent analytical, communication, written, and verbal skills.
• Ability to drive the collection, organization, and analysis of financial and operational data.
• Proficiency in contracting, financial, legal, and business acumen with global studies.

Travel: 20%

The target salary range for this full-time role is $182,000 - 215,000 bonus equity benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.