Associate Director Global Study Operations

Company: Lyten
Location: San Rafael
Posted on: May 4, 2025

Job Description:

Who We AreBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.The People & Process Manager of Study Specialists is responsible for ensuring consistent application of line management and process execution across the work portfolio to support trial delivery at BioMarin. This role involves mentoring, coaching, and managing Study Specialists, contributing to process development, and continuously improving trial execution methods.This position combines the complexity of managing early and late-stage development studies, supporting rapid development for registration, and focusing on life cycle management post-approval. The role reports to the Head of People and Process Management.Leadership Responsibility:

• Manage 8-12 Study Specialist and Senior Study Specialist staff.Direct reports will collaborate with cross-functional departments and vendors involved in clinical trial execution, including Clinical Development, Medical Affairs, Regulatory, Data Sciences, Clinical Supply Chain, Pharmacovigilance, and department heads.Minimum Requirements:
  • 8+ years in the pharmaceutical industry with a BA/BS in life sciences, nursing, or related field, or 6+ years with a master's degree.
  • At least 2 years of management experience.Role Specific Minimum Requirements:
    • Strong leadership skills with experience managing, coaching, and motivating diverse teams.
    • Expertise in all phases of clinical trial management and vendor oversight.
    • Solid business acumen, experience with agile methodologies, and excellent communication skills.
    • Experience with diversity, equity, and inclusion frameworks.
    • Effective communication and stakeholder management skills.
    • Innovative mindset and change management experience.
    • Proactive, adaptable, and capable of navigating ambiguity and conflict.
    • Professional maturity for confidential engagement with employees, vendors, and teams.Key Responsibilities:People Management:
      • Support staff training and development, including IDPs and coaching.
      • Align program delivery expectations with Study Managers.
      • Lead, develop, and retain high-performing teams, setting clear goals and fostering an inclusive environment.
      • Build effective relationships across functions and support a culture valuing diversity and inclusion.Process Management:
        • Collaborate on process improvements and project management.
        • Ensure compliance with SOPs, ICH-GCP, and regulatory standards.
        • Maintain high-quality standards and timely delivery of projects.Note: This description is not exhaustive and may include other duties. BioMarin is an Equal Opportunity Employer offering a comprehensive benefits package, including salary, bonuses, stock incentives, and health insurance. For more information, visit https://careers.biomarin.com/benefits.
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Keywords: Lyten, Parkway-South Sacramento , Associate Director Global Study Operations, Executive , San Rafael, California