Associate Manager, Clinical Trials Regulatory Management

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. The Associate Director / Associate Medical Director is an emerging leadership position within Clinical Science. S/he leads tasks related to Clinical Science core deliverables across all stages of program and study design and execution, data analysis and regulatory filings as delegated by the Clinical Science Therapeutic area lead or other Clinical Science leader. building and leveraging relationships with external parties (KOLs, Investigators); conducting data analysis in support of reports and key messaging.
The Associate Director / Associate Medical Director may also take on the role of Medical Monitor for a study depending on clinical experience.
Scientific Expertise
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.
Data Analysis
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.
Clinical Science Communication and Collaboration
~ Serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed.

Clinical Study Monitoring
Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk.
Initiate and provide the scientific content and insight for development and review of: protocols, protocol amendments; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverables.
Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues.
Provide leadership to sites by developing or participating in training, answering investigator/site/HA questions about the protocol.
Conduct review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate interpretation including thorough review of SAEs and other important AEs (per the study specific Medical Monitoring Plan).
Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee (per protocol specific Protocol Deviation Plan).
Work closely with the Pharmacovigilance representatives providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels.
Collaborate with Biometrics to identify key issues, prepare content and facilitate discussions at study Data Review Board (internal) or Data Monitoring Committee (DMC).
Lead the selection of and interactions with independent Data Monitoring Committees (DMC).
Participate in and provide scientific advice, as appropriate, during key Database Lock (DBL) activities (final listing review, review of blinded tables, listings and figures (TLFs), etc.) and actively participate in all data snapshots taken (not limited to final DBL).
Contribute to and review Clinical Study Report (CSR) writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings).
Recommend and develop Key Opinion Leader (KOL) and Advisory Panel Networks, as appropriate.
Provide representation at regulatory meetings, as needed.
The Associate Medical Director will also act as the medical subject matter expert for review of clinical and safety data to ensure data are correct and presented with the appropriate medical interpretation and for discussing safety concerns with sites.
Governance and Communication
Provide timely and high-quality functional deliverables and contributions to Study Execution Team (SET).
Act as primary point of contact between SET and Clinical Science to ensure appropriate dissemination of information and communication (including functional managers and other relevant individuals).
Act as the medical and scientific subject matter expert (SME) to the SET with the ability to make decisions and recommendations on behalf of Clinical Science.
Proactively identify and communicate potential risks and mitigations relevant to the Clinical Science deliverables.
Contribute to the development and maintenance of study-specific plans; manage the development of study-specific plans that are the responsibility of the Clinical Science.
It is expected that the Associate Director / Associate Medical Director has the experience and knowledge required to demonstrate advanced skills in communication and collaboration, proactivity, scientific knowledge, drug development, data analysis, and scientific writing. Anticipate risks or issues to program or business and take the necessary steps to mitigate or address.
Proactively critique clinical and scientific evidence and research and interpret how findings may impact BioMarin clinical development plans and publication plans.
Demonstrate understanding of clinical study protocol scientific rationale, methodology, biostatistical concepts and data analysis and procedures through the life of the clinical trial.
The Associate Medical Director will also demonstrate relevant clinical and therapeutic area knowledge to support clinical decision making, problem solving, safety surveillance, as well as collaboration with external physician stakeholders.
Associate Medical Director: MD, MD/PhD (or equivalent).
Advanced degree in life or health sciences (e.g. PhD/PharmD/RN) may be considered.
2 or more years of relevant experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases desired; 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. #