Associate Medical Director, Late Stage Clinical Development- UK (also open in the US)
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.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\u00A0Associate Director / Associate Medical Director\u00A0is 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. This includes developing key documents to support study execution;\u00A0building and leveraging relationships with external parties (KOLs, Investigators); conducting data analysis in support of reports and key messagingThe\u00A0Associate Director / Associate Medical Director\u00A0may also take on the role of Medical Monitor for a study depending on clinical experience.\u00A0Responsibilities may include, but are not limited to:Scientific ExpertiseDevelop 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 timelinesDevelop scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reportsStay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirementsDevelop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publicationAttend and contribute to relevant scientific conferences, seminars or presentationsEngage and establish rapport with KOLs and scientific or clinical expertsContribute to content and submission of abstracts to key symposiaWork with CLS and Clinical Operations to ensure the success of Investigator Meetings by contributing and presenting scientific content\u00A0Data AnalysisDevelop 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\u00A0Clinical Science Communication and CollaborationServe 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\u00A0Clinical Study MonitoringAct as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating riskInitiate and provide the scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverablesAct as study scientific subject matter expert and main point and of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issuesProvide leadership to sites by developing or participating in training, answering investigator/site/HA questions about the protocolConduct 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 neededProvide leadership in compliance with GCP and appropriate reporting standardsWork 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 labelsCollaborate 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)Present study updates and topline results to CLS leadership, as neededRecommend and develop Key Opinion Leader (KOL) and Advisory Panel Networks, as appropriateProvide representation at regulatory meetings, as neededThe 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 siteGovernance and CommunicationProvide 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 meetingsAct as the medical and scientific subject matter expert (SME) to the SET with the ability to make decisions and recommendations on behalf of Clinical ScienceProactively identify and communicate potential risks and mitigations relevant to the Clinical Science deliverablesContribute to the development and maintenance of study- specific plans; manage the development of study-specific plans that are the responsibility of the Clinical ScienceCollaborate with CLS Therapeutic Area Lead, CDTL and CSL on all study related decisions, as appropriateEscalate issues affecting CLS function deliverable quality, timelines, resources or budget, as appropriate\u00A0
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