Associate Director Global Study Operations

Company: Initial Therapeutics, Inc.
Location: San Rafael
Posted on: June 1, 2025

Job Description:

Who We Are

BioMarin 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 accountable for the consistent application of line management and process execution across the book of work to support trial delivery at BioMarin. In this role the PPM manager is the mentor, coach, and line-manager for the Study Specialist. In addition, the incumbent will be expected to contribute to the process development based on lessons learned, and innovative approaches to continuously improve the execution of trial delivery. This role combines the complexity of study execution in the early and late-stage development space, with the need for rapid development to support registration and the focus on life cycle management in the post approval space. This role will report to the Head of People and Process Management.Leadership Responsibility:

• The incumbent will manage between 8-12 Study Specialist and Senior Study Specialist level staff.Direct reports will interact with cross-functional departments and vendors involved in the execution of clinical trials including but not limited to Clinical Development, Medical Affairs, Regulatory, Data Sciences, Clinical Supply Chain, Pharmacovigilance, as well as the executives that are the function heads of those departments. Minimum Requirements:
  • Minimum of 8 years in the pharmaceutical industry with a BA/BS degree with a focus on life sciences, nursing, or related technical or scientific discipline or 6 years in the pharmaceutical industry with a master's degree
  • Minimum of 2 years management experience Role Specific Minimum Requirements:
    • Strong leadership attributes with solid line management experience, leading, coaching, and motivating a diverse team of individuals to reach their highest potential and successfully deliver on trial and program expectations.
    • Expertise in all phases of clinical trial management and vendor oversight
    • Solid business acumen with comfort in agile delivery in a complex learning environment, including the ability to produce and present clear, concise, professionally written communications and presentations.
    • Experience in working with Learning, Development, Engagement and Talent Strategy frameworks that welcome diversity, equity, and inclusion.
    • Effective written/verbal communication and people skills, with experience influencing and fostering collaborative relations with cross-functional stakeholders
    • Innovative mindset with proven history of championing and supporting change to positively impact the business and its stakeholders.
    • Proactive, flexible, adaptive, and successful navigation of self and team through conflict or ambiguity to seek clarity, structure, and solutions.
    • Professional maturity to engage effectively and confidentially (as warranted) with employees, vendors, and team members.Key Responsibilities may include but are not limited to:People Management focus:
      • People management to support training programs and resources to develop staff.
      • Support with Individual Development Plans (IDP), and conduct quarterly coaching conversations, mid and end of year assessments for direct reports.
      • Strong communication skills, including coaching direct reports on how to flex presentations or discussions based on the level of the audience and the critical information required.
      • Partner with Study Manager to align on program delivery expectations for direct reports, contribute to the development of process improvements and establish best practices to enhance the execution of trial delivery across the organization.
      • Effectively lead, develop, manage, and retain high performing teams; set vision and purpose through goals, clear and authentic communication.
      • Ensure visibility and alignment of corporate and functional goals with individual goals.
      • Build and manage effective working relationships with other line managers and leaders to ensure effective relations to support an engagement strategy that values diversity, inclusion, and equity.
      • Build and establish a positive team through management best practices including but not limited to giving timely feedback, understanding retention issues, and ensuring clear priorities.
      • Build and establish a positive work environment by encouraging mutual respect, and accountability on a functional and project level, both locally and globally to implement and deliver the study.
      • Develop and manage partnerships with key enterprise business partners, SMEs, and stakeholders to support a strong network fostering an open and collaborative environment across the global network.Process Management focus:
        • Collaborate with key business partners and contribute to the process improvement efforts and overall success of the wider Global Study Operations team.
        • Collaborate with stakeholders and cross-functional leads to manage project scope, plan resources, maintain schedules, and facilitate open bi-directional communication.
        • Contribute to the implementation of strategies and plans to improve complex drug development processes and capabilities.
        • Ensure compliance with all SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of global clinical trial execution.
        • Establish and maintain high quality clear work standards for projects while ensuring timely delivery of customer's business requirements within the specific business initiative and project timelines.
          
          Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
          
          Equal Opportunity Employer/Veterans/Disabled
          
          An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Keywords: Initial Therapeutics, Inc., Mountain View , Associate Director Global Study Operations, Executive , San Rafael, California