Senior Clinical Study Manager

2 weeks ago

London, Greater London, United Kingdom BIOMARIN Full time
Job Summary

We are seeking a highly skilled Senior Clinical Study Manager to join our team at BioMarin. This role will be responsible for leading clinical programs across various phases, from proof-of-concept to Phase 3 and BLA/NDA/MAA filing.

About Us

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.

Responsibilities
  • Scientific Expertise
    • Develop key documents to support trial execution and regulatory submission, including IND Annual Reports, Investigator Brochures, Briefing Books, and Pediatric Plans.
    • Support 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 success of Investigator Meetings by contributing and presenting scientific content.
  • Data Analysis
    • Develop thorough understanding of clinical trial data to help guide 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 scientific subject matter expert and primary contact for assigned clinical study; take proactive approach to identifying issues and mitigating risk.
    • Initiate and provide 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 rationale, 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).
    • Attend and present at Investigator Meetings, as needed.
    • Provide leadership in compliance with GCP and appropriate reporting standards.
    • Work closely with Pharmacovigilance representatives providing medical input into safety reports, including SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs), 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 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).
    • Present study updates and topline results to CLS leadership, as needed.
    • 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).
    • Provide agenda topics to be discussed during SET meetings.
    • 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.
    • Collaborate with CLS Therapeutic Area Lead, CDTL, and CSL on all study-related decisions, as appropriate.
    ,

Estimated salary: $120,000 - $160,000 per year.

Please note that this estimate may vary based on location and experience.

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