- Provide oversight and leadership to cross-functional Study Team(s)
- Develop the strategies and tactics to ensure the team is high functioning and executes according to timelines, budgets, and corporate objectives
- Plan resources and tasks to meet corporate goals for timely initiation and completion of clinical studies
- Recruitment and mentorship of development operations personnel in US and China
- Be an active member of Clinical Development Teams to provide direction and oversight to Study Teams
- Manage overall study activities, including vendor selection, investigator recruitment and selection, study start-up, enrollment, data collection, study close out, and reports
- Accountable for CRO selection, development of RFPs, budget negotiations, and overall CRO management
- Manage team members responsible for CRO and vendor oversight.
- Develop and review SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials
- Oversight of clinical vendor and site budgets and contract negotiation
- Contribute to the development of study plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
- Interact with investigators and thought leaders for SAB meetings, development of patient engagement plans, and study execution
- Participate in investigator meetings
- Coordinate clinical site audit activities including pre-inspection training at clinical sites in partnership with QA
- Establish systems for tracking of various activities during clinical trials, e.g., accruals/invoices, tracking of clinical reviews, data query resolution, etc.
- Oversight of Trial Master Files according to applicable domestic and/or international regulations and internal SOPs
- Participate in monitoring visits, including Site Qualification, Site Initiation, and Close Out as needed
- Able to travel internationally to meet with team members as needed to build collaboration across development operations
- BS and/or graduate degree in a technical discipline with a minimum of years of pharmaceutical and biotechnology industry experience running multinational clinical trials
- Proven success in leading and coordinating global, cross-functional clinical operations teams
- Proven ability to build strong relationships with global CROs/vendors and to manage CROs and vendors throughout entire clinical operations life cycle
- Excellent interpersonal skills, strong written and verbal communication/presentation skills necessary to meet the needs of various audiences
- Strong team leadership experience and motivational skills
- Able to problem solve and use good judgement
- Detail oriented
- Strong program management skills
- Strong people management skills
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Ad/d Clinical Operations
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Director, Clinical Operations
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Structure Therapeutics Inc South San Francisco, United StatesPOSITION SUMMARY · The Director, Clinical Operations will build and lead a diverse and dynamic Study Team · responsible for planning and coordinating the conduct of clinical trials, including protocol · development, site and vendor assessment, and ensuring adherence to GCP and ot ...
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Director, Clinical Operations
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Aligos Therapeutics, Inc. South San Francisco, United StatesAbout Aligos: · Ready to make a difference in the lives of patients all around the world? As a leading clinical-stage biopharmaceutical company, that's our top priority. · Established in 2018, Aligos became a publicly-traded company in 2020. Our employees thrive in a science-firs ...
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Director, Clinical Operations
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Director, Clinical Operations
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Structure Therapeutics South San Francisco, United StatesJob Description · Job DescriptionSalary: · 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 inter ...
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BioPhase South San Francisco, United StatesTHE ROLE · The VP of Clinical Operations is a critical leadership position and is responsible for leading all clinical operations activities within the organization. This individual will be primarily focused on managing and executing domestic and international clinical studies, e ...
Director, Clinical Operations - South San Francisco, United States - Structure Therapeutics
Description
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.
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.#hybrid.
POSITION SUMMARY
The Director, Clinical Operations will build and lead a diverse and dynamic Study Team responsible for planning and coordinating the conduct of clinical trials, including protocol development, site and vendor assessment, and ensuring adherence to GCP and other applicable guidelines and regulations.
In addition, the Director, Clinical Operations will partner with cross-functional stakeholders in Clinical Development and other functions to develop systems and procedures to assure uniform operation of all projects in the department.
This position is accountable for Clinical Operations deliverables and for updating management on the status of responsible programs.ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
The target salary range for this full-time role is $218,000 - $262,000 + 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.
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Director, Clinical Operations professionals in South San Francisco
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Angelisa Marie Marie Letele
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