Associate Director, Clinical Operations

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

The BioMarin Clinical Operations (CLO) function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Role Summary

The Associate Director level is the entry level role of Clinical Program Lead (CPL) a critical role accountable for ensuring the efficient execution of one or more Clinical Operations programs throughout the clinical development lifecycle.  The responsibilities include oversight of the program team, accountability of the Study Execution Team (SET), associated vendors, program quality, program budget, and timeline. In addition, the CPL serves as a key member of the BioMarin Clinical Development Team and is the conduit from the Study Execution Team for risk and issue escalations.  The Associate Director will provide strategic and tactical input and updates to executive leadership and align and collaborate closely with cross functional stakeholders. The CPL demonstrates sound decision-making, proactive and clear communication, and presentation skills, and is highly adept at representing the program both internally and externally.

Within the role the candidate is expected to show and have advanced knowledge and experience in the following core and technical competencies:

• Core:
  • Decision Making, Strategic Thinking, and Problem Solving
  • Influence and Collaboration
  • Agility and Proactivity
  • Leadership
  • Communication and Collaboration
• Technical:
  • Data Analysis and Interpretation
  • Drug Development and Study Design
  • Product and Therapeutic Area Knowledge

With mastery in the following technical competencies:

• Study Management and Execution
• Compliance and Quality

Key responsibilities include but are not limited to:  

Clinical Development strategy and planning:

• Contribute to the clinical development strategy for a program or programs providing input on the design and operationalization of the Clinical Development Plan (CDP) and supporting studies. Provide operational expertise and guidance on all relevant program and study deliverables. Ensure development and implementation of recruitment and retention strategies as applicable to support enrolment according to projections.

Overall program operational accountability:

• Provide global program-level oversight, leadership, and direction, ensuring that Clinical Operations team members and cross-functional Study Execution Team achieve assigned deliverables within timelines, budget, and in accordance with BioMarin’s quality standards. Ensure consistent study execution practices to drive successful outcomes and deliverables across all studies in a program. Ensure effective communication across all key program stakeholders.
• The primary point of escalation for program and study execution issues or risks related to deliverables, vendors, quality, timelines, and budget when staff or study team members are not able to resolve independently; take ownership of appropriately escalated issues and drive to resolution.
• Provides strategic and tactical input, guidance, and reports on program progress, risks, issues, metrics as needed to executive leadership across WWRD and BioMarin as appropriate

Program vendor oversight

• Ensure all study managers on the program understand and follow vendor oversight guidance and governance as documented in the CLO vendor oversight playbook. Act as the escalation point for all program vendor issues in accordance with the BioMarin Vendor Governance model.

Departmental contributions:

• Drive and implement critical cross functional initiatives across the portfolio of programs and/or Clinical Operations to improve efficiency and effectiveness of clinical program development
• Contribute to the development of a cohesive, balanced, and high-functioning team focused on driving continuous improvement for the organization. Mentor and manage team members in alignment with a matrix team environment

Education

• BA/BS degree (advanced degree preferred) with a focus on life sciences, nursing, or related technical or scientific discipline

Experience

• 10+ years global clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS; 8+ years with MA/MS; or a PhD with 5 years’ experience; or equivalent experience.
• Prefer clinical trial operations experience in Gene therapy, but not mandatory.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.