Bryan Boone Email & Phone Number

Philadelphia, Pa, Us

Basel, Baselstadt, Ch

Portfolio Team Leader responsible for the overall execution related performance (KPIs) and ensured project deliverables and milestones were met for specialty oncology (all NVS radioligand trials and cell and gene therapy trials within the United States). Led a team of clinical project managers and feasibility managers to advance project management and implement global strategy.

Basel, Baselstadt, Ch

In this role, I was responsible for providing cross functional leadership for two blockbuster drugs. This included over 10 indications across several development units (Immunology, Hematology, Dermatology and Respiratory). As the project lead on the Global Program Team (GPT), I ensured the consistency of our program strategy and development plan by providing realistic planning (budget, resources, timelines) with functional alignment. This has allowed me to lead the teams through several tollgates and governance boards successfully which notably included two Submission Decision Points (SDPs).

Basel, Baselstadt, Ch

As the Clinical Development Director, I was an executive leader with a core team of 8+ and contributing to 5 studies across 48 countries. I drove the execution of the clinical program in partnership with global line functions, assigned global trial directors (GTDs), and regional/country medical associates. Additionally, I conducted ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) and appropriate oversight from the Medical Lead. Impactfully, I was a critical member of the safety extension study being conducted in over 40 countries. I was also the acting as the Chair for the Global Clinical Team (GCT) and co-authored briefing books for several indications on high priority projects.Despite the complex obstacles presented by the COVID-19 pandemic, I was still able to engage my team and we successfully locked the database of a large global trial. In the process, I became a clinical lead for accessing home visits and digital devices into our trial designs. This demonstrated my ability to drive positive program outcomes.

Basel, Baselstadt, Ch

Moving up in the organization, I facilitated clinical leadership, strategic insight, and development of trial-related documents for assigned clinical trials consistent with the integrated development plan (IDP). Here I was able to partner with key investigators to optimize scientific quality and innovation of program and/or clinical study design, execution, reporting, and publication. I co-led 13 protocol trainings in Germany, Japan, US, Taiwan, Argentina, Czech Republic, and China.Here I co-managed the Xolair pediatric submission for Canada, which encompassed review of the clinical overview, summary of clinical safety, and summary of clinical efficacy to be submitted to Health Authorities.A major accomplishment was when my team and I achieved our FPFV (first patient first visit), and we are now exceeding recruitment timelines. I was also tapped internally and nominated for the Voyage Early Talent Engagement Journey. This identified me as a future leader within the company and allowed me to undertake a 9-month leadership program.

Basel, Baselstadt, Ch

Tapped to join the Novartis team, I took on a lead role to ensure adequate medical writing resources were provided for dossier preparation. The core of my role surrounding authoring, reviewing, and managing clinical and safety documents. This encompassed non-registration clinical study reports (CSR) [EXJADE®], development safety update reports (DSUR), clinical trial registry database (CTRD), risk management plans (RMP) in neuroendocrine tumor population (AFINITOR®), periodic safety update reports (PSUR), clinical pharmacology reports, common technical document (CTD) Module 2 summary documents, and health authority responses.Notably, I authored the RMP as a core member of Afinitor Radient 4 submission team. This role was a tremendous stepping stone into my progressive career with Novartis.

Stepping back into the Merck team, I conducted real-time medical oversight of ongoing trials. I strove to deliver appropriate clinical safety assessment and risk management of compounds. A major moment in my career is when I co-led the Grastek® submission, which was presented to the FDA and approved in April of 2013. I was also a member of the Grastek® advisory committee. And finally, I also co-authored the pivotal CSR for the Ragwitek® submission.

Us

In this role, I capitalized on prior experience to track clinical trial progress through regular documented contact with sites, regional site managers, and vendors. I diligently documented study start-up and gained document approval in RASS. I also monitored data during the course of the study. My focus would be to identify potential issues with data and provide feedback to management and resolutions to remediate issues.

Taking a new step in my career, I entered Merck to lead as the primary site contact for all operational and protocol issues in support of clinical studies. I provided support to clinical monitor in scientific leadership/investigator initiatives. Additionally, I acted as primary site contact for operational and protocol issues in support of clinical studies. Effectively, I authored and reviewed institutional review boards (IRBs), and regulatory documentation. Over my time with the organization, I was an instrumental player in Merck’s Legacy CSR Project. This was a high visibility project with over 300 studies. I personally led the freezing/database lock of 63 studies.

New York, New York, Us

Entering the realm of pharmaceuticals and clinical research, I joined Pfizer to facilitate the full spectrum of clinical trial operations. The core of my role encompassed consent authoring, vendor selection, contract review and approval, investigator meeting planning, clinical site monitoring and training, safety monitoring, patient enrollment tracking, and all clinical data review.For trials, I would procure supplies, managed site start-up activities, and prepare status reports. The realm of my experience includes cardiovascular (Inspra®), ophthalmology (Macugen®), respiratory and allergy (Spiriva®), central nervous system (Aricept®), and urology (Viagra®).

Master Of Business Administration - Mba, Business Administration And Management, General

Bachelor'S Degree, Biology, General