Associate Director Global Study Operations

BioMarin Pharmaceutical; San Rafael (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative biotechnology firm is seeking a People & Process Manager to lead a team of Study Specialists. This role combines leadership with strategic process management to enhance clinical trial execution. You will mentor and develop your team while collaborating with cross-functional departments to ensure successful project delivery. The ideal candidate will have extensive experience in the pharmaceutical industry, strong leadership skills, and a passion for fostering an inclusive and collaborative work environment. Join a dynamic team committed to advancing human health through groundbreaking research and development.

Qualifications

• 8+ years in the pharmaceutical industry with a relevant degree.
• 2+ years of management experience.

Responsibilities

• Manage and mentor a team of Study Specialists.
• Collaborate on process improvement initiatives.

Skills

Leadership Skills

Clinical Trial Management

Communication Skills

Agile Delivery

Problem-Solving

Education

BA/BS in Life Sciences

Master's Degree

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 contribute to process development based on lessons learned and innovative approaches to continuously improve trial execution. This role combines the complexity of study execution in early and late-stage development, with the need for rapid development to support registration and focus on lifecycle management post-approval. The role reports to the Head of People and Process Management.

Leadership Responsibility:

• The incumbent will manage between 8-12 Study Specialist and Senior Study Specialist staff. These direct reports will interact with cross-functional departments and vendors involved in clinical trial execution, including Clinical Development, Medical Affairs, Regulatory, Data Sciences, Clinical Supply Chain, Pharmacovigilance, and executive leaders of these departments.

Minimum Requirements:

• Minimum of 8 years in the pharmaceutical industry with a BA/BS in life sciences, nursing, or related discipline, or 6 years with a master's degree.
• Minimum of 2 years management experience.

Role-Specific Minimum Requirements:

• Strong leadership skills with experience managing, coaching, and motivating diverse teams to meet trial and program goals.
• Expertise in all phases of clinical trial management and vendor oversight.
• Solid business acumen with experience in agile delivery and effective communication skills.
• Experience with Learning, Development, Engagement, and Talent strategies emphasizing diversity, equity, and inclusion.
• Excellent written and verbal communication skills, with the ability to influence and foster collaboration across functions.
• Innovative mindset with a proven history of supporting change initiatives.
• Proactive, adaptable, and capable of navigating conflict or ambiguity to find solutions.
• Professional maturity for effective and confidential engagement with employees, vendors, and team members.

Key Responsibilities:

People Management:

• Support training programs and resources for staff development.
• Manage Individual Development Plans (IDP), conduct coaching, and performance assessments.
• Coach team members on communication and presentation skills.
• Partner with Study Managers to align on program delivery, develop process improvements, and establish best practices.
• Lead, develop, and retain high-performing teams; set clear goals and communicate effectively.
• Ensure alignment of individual and organizational goals.
• Build effective relationships across departments to support an inclusive and collaborative environment.
• Create a positive team environment through feedback, understanding retention issues, and setting priorities.
• Foster a respectful and accountable work environment locally and globally.
• Develop partnerships with key stakeholders and SMEs to promote a collaborative network.

Process Management:

• Collaborate on process improvement initiatives and contribute to the success of Global Study Operations.
• Coordinate with stakeholders to manage project scope, resources, schedules, and communication.
• Implement strategies to enhance drug development processes and capabilities.
• Maintain compliance with SOPs, ICH-GCP guidelines, regulations, and safety standards.
• Ensure quality standards and timely delivery of projects aligned with business requirements.

Note: This description is not exhaustive and may include other duties as assigned.

Equal Opportunity Employer/Veterans/Disabled

We are an equal opportunity employer. All qualified applicants will receive consideration 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.