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Senior Manager of Clinical Trials

2 months ago

South San Francisco, California, United States Structure Therapeutics Full time
Job Overview

Salary: Competitive compensation package

Structure Therapeutics is at the forefront of developing transformative therapies for patients, utilizing cutting-edge structure-based and computational drug discovery methodologies. Our innovative platform integrates state-of-the-art molecular interaction visualization, computational chemistry, and data synthesis to create orally available, superior small molecule therapies that address the limitations of existing biologic and peptide treatments. We are advancing a clinical pipeline of unique therapies aimed at chronic conditions with significant unmet medical needs, including cardiovascular, metabolic, and pulmonary diseases.

POSITION SUMMARY

We are seeking a dedicated Senior Clinical Trial Manager (Sr. CTM) to join our Clinical Operations team. This role presents a unique opportunity to contribute to a dynamic organization focused on transforming biologics and peptides into impactful small molecule therapies. The Sr. CTM will oversee the daily management of global clinical trials, coordinating with internal teams, contract research organizations (CROs), various service providers, clinical monitors, and trial sites. The focus will be on managing multinational, multicenter Phase II studies, with potential involvement in additional studies and indications as necessary. The Sr. CTM will collaborate closely with the Clinical Development Operations team, receiving assignments in the form of objectives, ensuring that deliverables are met on schedule and within budget.

This position will also involve working alongside a cross-functional team to ensure clinical trials are executed efficiently and in compliance with standard operating procedures (SOPs), ICH/GCP guidelines, country-specific regulatory requirements, and organizational goals.

KEY RESPONSIBILITIES

  • Lead and coordinate global cross-functional study teams throughout all phases of the study lifecycle (initiation, execution, closure).
  • Collaborate with internal stakeholders to drive the RFP and RFI processes, evaluate service providers, analyze budgets and proposals, conduct bid defense meetings, award contracts, and negotiate complex agreements.
  • Provide oversight and guidance to CROs and service providers to ensure accurate coordination of clinical study activities.
  • Assist with inspection readiness activities, which may involve developing, modifying, and implementing policies to maintain high quality and integrity in all study operations.
  • Coordinate clinical study timelines with project management and escalate issues that may affect timelines or deliverables.
  • Lead or participate in the creation and review of study documents, including CRF design, project plans, and TMF plans.
  • Adhere to established processes and procedures, recommending changes to SOPs and policies to ensure comprehensive and compliant operations.
  • Identify potential study issues or risks, escalate as necessary, and propose/implement solutions.
  • Manage study sites and related activities, including feasibility assessments, site selection, initiation, subject recruitment, enrollment, study management, monitoring report reviews, and data management.
  • Provide regular updates to the Study Lead and other stakeholders, proactively identifying and managing issues.
  • Coordinate with the Study Lead and Finance to monitor vendor accruals and financial status against budget.
  • Prepare or review clinical sections of regulatory submission documents and responses to inquiries from ethics committees or health authorities.
  • Monitor study progress for potential changes in scope to ensure timely adjustments.
  • May oversee and manage the study budget, including site and service provider expenses.
  • Facilitate ongoing communication regarding operational issues and provide accurate progress reports to the Study Management Team and Clinical Development Team.
  • Ensure data and information in study-specific systems (e.g., EDC, CTMS, eTMF) are current and accurate.
  • May lead collaborative efforts on project teams or contribute as a subject matter expert on key initiatives to identify and implement process improvements.
  • Perform other supportive duties as assigned to achieve operational objectives.

COMMUNICATION & INTERPERSONAL SKILLS

  • Excellent written and verbal communication skills, with the ability to convey objectives clearly and maintain open communication with internal stakeholders and service providers.
  • Strong negotiation and project management skills, capable of coordinating across multiple projects and timelines.
  • Ability to integrate and collaborate effectively within a remote cross-functional team environment.
  • Proficient in prioritizing and managing multiple activities while remaining flexible and responsive to changing priorities.
  • Exemplifies core values: Passion, Integrity, Innovation, and Patient Focus.

CORE COMPETENCIES, KNOWLEDGE, AND SKILL REQUIREMENTS

  • Proficient in PC applications; MS Office skills (Outlook, Word, Excel, PowerPoint) required.
  • Comprehensive understanding of FDA and EU regulations, ICH Guidelines, and GCP requirements governing clinical trial conduct.
  • Flexibility to work on-site as required.

EDUCATION & EXPERIENCE

  • Bachelor's degree or equivalent in a scientific or healthcare discipline preferred.
  • 7+ years of experience in a biotech or pharmaceutical environment, leading cross-functional clinical activities with increasing responsibility.
  • Minimum of 3+ years of study management experience in clinical and drug development, including oversight of studies outsourced to CROs.
  • Experience in selecting, managing, and overseeing sites, CROs, specialty labs, and other service providers in global studies.
  • Experience in supporting SOP development and implementation is preferred.
  • Experience working with global teams is preferred, particularly in Asia-Pacific and EU regions.

TRAVEL - Up to 30% may be required.

The target salary range for this full-time role is competitive, including bonuses, equity, and benefits. Salary ranges are determined based on level and scope of responsibilities, as well as location, with individual pay further influenced by relevant experience, specific job skills, education, and training.