Bryan Boone

Bryan Boone Email and Phone Number

Global Program Director @ Novartis
Philadelphia, PA, US
Bryan Boone's Location
New York City Metropolitan Area, United States, United States
Bryan Boone's Contact Details

Bryan Boone work email

Bryan Boone personal email

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About Bryan Boone

Bryan Boone is a Global Program Director at Novartis. He possess expertise in clinical trials, clinical development, clinical research, gcp, ctms and 18 more skills. Colleagues describe him as "Bryan is a well respected professional. he us hard working, fast leaner and can succeed with minimal supervision. He us dedicated and will work hard to succeed and play the role as a team member or leader to achieve goals and success", "I had the honor of working with Bryan for a number of years at Merck. He is an invaluable resource to any team and often uses his experience and depth to think outside the box coming up with creative solutions with big impacts. He is a team player and seamlessly takes the lead when an issue arises- driving to a quick and decisive resolution. He diligently works to build strong relationships with his peers, key opinion leaders, direct reports etc. , which helps him work efficiently and fruitfully with all of his teams. Anyone who has had the opportunity to work with Bryan understands how valuable Bryan is to the team!", and "Recommending Bryan is effortless, let me tell you why; Bryan is an individual with integrity who demonstrates a polished and professional manner in all aspects of his role. He consistently showcases his commitment in providing high quality deliverables and outputs (in accordance with GCP/ICH) on the clinical trials he oversees; with both patient safety and data integrity being a paramount priority. When sharing challenges, proposals or operational overviews, he communicates with clarity and delivers messages clearly and directly. Bryan has an outstanding ability to remain calm under stress and negotiate under pressure - with skill and tact. Leveraging logic, he is able to consider alternative solutions, displays flexibility and creativity in thinking and makes good use of observations in decision making. His clinical trial subject matter expertise demonstrates a high level of competence and self confidence, all while remaining humble which is great complimentary skill set to have. Bryan fosters an incredible relationship with those in Clinical Quality Assurance who provide support to the trials within his therapeutic area; one of trust, collaboration, teamwork and partnering. It has been and continues to be a pleasure working with Bryan; he is a valued asset."

Bryan Boone's Current Company Details
Novartis

Novartis

View
Global Program Director
Philadelphia, PA, US
Website:
novartis.com
Employees:
79781
Bryan Boone Work Experience Details
  • Novartis
    Global Program Director
    Novartis
    Philadelphia, Pa, Us
  • Johnson & Johnson Innovative Medicine
    Sr Director, Compound Development Team Leader, Immunology
    Johnson & Johnson Innovative Medicine Jan 2024 - Present
  • Novartis
    Portfolio Team Lead, Specialty Oncology
    Novartis May 2023 - Jan 2024
    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.
  • Novartis
    Global Program Director, Immunology
    Novartis Nov 2020 - May 2023
    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).
  • Novartis
    Clinical Development Director, Respiratory And Allergy
    Novartis Apr 2018 - Nov 2020
    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.
  • Novartis
    Associate Clinical Development Director, Respiratory And Allergy
    Novartis Nov 2015 - Apr 2018
    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.
  • Novartis
    Submission Writer, Oncology
    Novartis Nov 2013 - Oct 2015
    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.
  • Merck
    Clinical Scientist, Respiratory And Immunology
    Merck Mar 2012 - Nov 2013
    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.
  • Forest Laboratories (Now Abbvie)
    Senior Clinical Scientist, Respiratory
    Forest Laboratories (Now Abbvie) Oct 2011 - Mar 2012
    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.
  • Merck
    Early Clinical Scientist, Clinical Pharmacology
    Merck Oct 2009 - Oct 2011
    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.
  • Pfizer
    Clinical Trial Associate
    Pfizer 2007 - 2009
    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®).

Bryan Boone Skills

Clinical Trials Clinical Development Clinical Research Gcp Ctms Pharmaceutical Industry Protocol Fda Cro Oncology Therapeutic Areas Drug Development Good Clinical Practice Clinical Study Design Regulatory Affairs Clinical Trial Management System Medical Writing Cro Management Biotechnology Regulatory Submissions Ind Inform Ophthalmology

Bryan Boone Education Details

  • California State University, Monterey Bay
    California State University, Monterey Bay
    General
  • Oakwood University
    Oakwood University
    General

Frequently Asked Questions about Bryan Boone

What company does Bryan Boone work for?

Bryan Boone works for Novartis

What is Bryan Boone's role at the current company?

Bryan Boone's current role is Global Program Director.

What is Bryan Boone's email address?

Bryan Boone's email address is br****@****tis.com

What schools did Bryan Boone attend?

Bryan Boone attended California State University, Monterey Bay, Oakwood University.

What skills is Bryan Boone known for?

Bryan Boone has skills like Clinical Trials, Clinical Development, Clinical Research, Gcp, Ctms, Pharmaceutical Industry, Protocol, Fda, Cro, Oncology, Therapeutic Areas, Drug Development.

Who are Bryan Boone's colleagues?

Bryan Boone's colleagues are Lexington Wilson, Wendi Ni, Emmanuel Sunday, Walid Shalaby, Girish Rupani, Markus Wunderlin, Fatima G..

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