Angela R Jones-Leone
Green Lane,PA
Summary
Strategic-thinking professional with 17+ years of experience in medical affairs at the local and global levels. Ability to handle multiple projects simultaneously with a high degree of accuracy. Proven results within the organization and seeking a position that offers professional challenges utilizing my interpersonal and problem solving skills.
Overview
18
18
years of professional experience
Work History
Global Medical Affairs Senior Medical Director
Daprodustat, Specialty Medicine
03.2022 - Current
- Lead for annual global medical strategic and tactical business planning with co-partnering with commercial with the integration into the daprodustat business plan
- Global medical launch lead on strategic planning and execution (US) to make sure all markets are delivering on medical KPIs at 12, 6, and 3 months
- Medical lead for US partnership on launch and business strategy and execution
- Lead the unmet needs section of FDA advisory board committee meeting on both GSK briefing document and presentation
- Lead the unmet needs publication with a key expert and MSL slide deck for digital engagement
- Lead for all copy approval materials including, core claims, eDA, and website
- Lead for our bi-monthly GMAT meetings (i.e., restructuring the GMAT through new optimization forum, development of key agenda items)
- Medical competitor intelligence lead on communications to teams, development of materials for LOCs to train teams
- Mentoring/sponsoring a new secondee on GSK Code for copy approval sign-off and global medical affairs basics
- Lead the reworking the educational strategy on the risk of worsening of heart failure
- Lead MSL training on objection handling in preparation of launch activities
- Co-leading with our daprodustat insight lead to pilot our MD2i process from insights into metrics to measure how daprodustat is tracking against our SSOs
Global Medical Affairs Senior Scientific Director
Specialty
03.2017 - 03.2022
- Lead the development of annual global medical strategic and tactical business planning
- Lead the development of Lupus Nephritis strategic planning and execution with US, EU, and Japan for medical
- Implement and execute external engagement strategic plan with the top global experts in nephrology
- Regional global medical lead for US, China, and Japan regions
- Provide local product and disease lectures & webinars to external experts
- Provide oversight and medical expertise to support medical and commercial teams to deliver launch activities
- Interface with and coordinate medical activities with commercial, market access, R&D, and value evidence key matrix partners
- Provide medical and scientific input and review of publications/data presentations
- Lead coordination/development all Scientific Engagement activities (global advisory board meetings, Scientific Workshops, and EE meetings)
- Lead planning/execution of global symposia at scientific congresses, including planning scientific content with external experts
- Partner with key external clinical experts on evidence generation gaps and strategy for the treatment evolving landscape in SLE
- Accountable for ISSs and SCSs program for belimumab within the integrated evidence plan
- Accountable for all medical insights and collaborating with commercial insights lead
- Participating in designing and implementation for the MD2i process at GSK
- Serve as medical representative on medical commercial Strategy team (MCST) and medical matrix team meetings for both US and Global
- Therapeutic experience: Systemic Lupus Erythematosus (SLE) and lupus nephritis
- Congress Strategy lead for Immunology and Specialty Medicine including execution of medical booths at congresses across the global\ and GSK-led medical education programs and accountability on managing the over budget
Lead Medical Affairs Scientist
GlaxoSmithKline
10.2005 - Current
- For the Diabetes Franchise Team (US & Global):
- Diabetes products (Tanzeum and Avandia franchise) for ensuring claims and promotional materials are medically appropriate for the target audience, clinically relevant, consistent with current medical practice, consistent with prescribing information, and medically correct
- Prepare data on file summaries to support promotional materials with appropriate data and references
- Partner with commercial franchise brand team by representing the clinical department for all clinical content questions at speaker trainings
- Assist in training sales force by presenting clinical trial data
- Collaborate with regulatory to ensure the clinical/medical information conveyed in promotional material is compliant with US regulations
- Participate in labeling discussion and preparation of the product fair balance for all consumer and professional materials
- Working with safety on the REMS program, Phase 3b/4 clinical plan/life cycle management, organizing and participating in advisory boards for clinical, global health outcomes, and commercial, key role in the North America and Global Launch planning team, contribute to the discussion between commercial and medical (MCST), co-chair the MMT, preparing pre-clearance affirmative promotional material, support medical information (e.g., letter generation, disease state slides preparation), training sales reps, and medical services, and working with the patient advocacy with the professional organizations
- Field activities including partnering with MSLs and sales reps on Scientific Engagement, meeting with External Experts at Congresses or at the office, delivered promotional programs face to face and webinars
- Support Medical Information Booths US and Global
- Designing and implementing clinical trials to support evidence generation gaps
Affairs Scientific/Clinical Scientist, Metabolic Therapy Area
US Pharma/Medical
10.2005 - 09.2012
- Provide oversight and medical expertise to support medical and commercial activities (i.e., copy approval)
- Clinical Investigational Leader responsibilities included as follows: updating investigator brochures, protocols, ICF, eCRF design, investigator meetings, data review and interpretation, CSRs, authoring of abstracts, posters, oral presentations at scientific engagement meetings, and full manuscripts
- Partner with clinical operations to support efficient conduct of study in all aspects through start up to database lock
- Organizing and leading advisory boards with key opinion leaders
- Clinical Scientist support the Albiglutide Phase II/IIIa program
- Responsible for completing 3 clinical studies including review blinded data, drafting AE narratives, reviewing and presenting top line data to senior management, review safety data with the safety team, compiling CSRs and CTR summaries, abstracts/posters for key congresses, and publications
- BLA Submission – authoring sections of the clinical overview and the integrated analysis of efficacy, and briefing document
- Lead Scientist that partners with safety and regulatory affairs in the managing and preparation of clinical sections of DSURs and NDA annual reports, sNDA/regulatory submission documents, and the Avandia briefing document and slides for the FDA Advisory Committee meeting July 2007
Education
PhD - Epidemiology
Public Health, University of Pittsburgh
Pittsburgh, PAMaster of Science - Biochemistry and Molecular Biology
Oklahoma State University
Stillwater, OKBachelor of Science - Cellular and Molecular Biology
Oklahoma State University
Stillwater, OKSkills
- Problem Solving
- Strategic Thinker
- Launching Products
- Communication Skills
- Team Player
- Innovative Thinker
- Leader
- Strategic Business Planning
- External Expert Management
- Key Performance Indicators
- Copy Approval
Affiliations
Secretary for Phi Lambda Upsilon Honorary Chemical Society from 1997-1998.
Member of Phi Lambda Upsilon Honorary Chemical Society, since spring 1997.
Member of American Association for the Advancement of Science, since 1995.
Member of American Society of Plant Physiologist, since 1998
Member of American Chemical Society, since 1999.
Additional Information
- 25+ Publications upon request
Timeline
Global Medical Affairs Senior Medical Director
Daprodustat, Specialty Medicine
03.2022 - Current
Global Medical Affairs Senior Scientific Director
Specialty
03.2017 - 03.2022
Lead Medical Affairs Scientist
GlaxoSmithKline
10.2005 - Current
Affairs Scientific/Clinical Scientist, Metabolic Therapy Area
US Pharma/Medical
10.2005 - 09.2012
PhD - Epidemiology
Public Health, University of Pittsburgh
Master of Science - Biochemistry and Molecular Biology
Oklahoma State University
Bachelor of Science - Cellular and Molecular Biology
Oklahoma State University