Associate Medical Director, Clinical Science (United States)

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.

About Worldwide Research and Development

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.

BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring. 

KEY RESPONSIBILITIES

• Develop key documents to support the components of trial execution and regulatory submission (including IND Annual Reports, Investigator Brochures, Briefing Books and Pediatric Plans)
• Support the design, update and implementation of Clinical Development Plans (CDPs), and work with Project Management to ensure progress in line with current plans and timelines
• Develop scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports
• Stay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
• Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication
• Attend and contribute to relevant scientific conferences, seminars or presentations
• Engage and establish rapport with KOLs and scientific or clinical experts
• Contribute to content and submission of abstracts to key symposia
• Work with CLS and Clinical Operations to ensure the success of Investigator Meetings by contributing and presenting scientific content

• Develop thorough understanding of clinical trial data to help guide the drafting of CSRs and Key Messages.
• Perform preliminary analyses on clinical study data as it becomes available to help build and guide Statistical Analysis Plans (SAPs)
• Help define study quality metrics and perform study data reviews during study execution to ensure integrity of accruing study data

• Serve as CLS representative and liaise with Pharmacovigilanc