Since 1997, AMS has been a competent partner to pharmaceutical and healthcare industry providers in areas of clinical research. As an experienced CRO, we offer 360 degree client support in all phases of clinical development and life-cycle management.

Serves as key member of leadership team, developing and directing Medical Affairs function for a commercial-stage biopharmaceuticals company specializing in innovative anti-infective agents. Develops and implements effective strategies to build credibility within the medical community, supports the development of key products, and manages communication and education plans. Develops long-term strategic plans, serves as key clinical spokesperson with stakeholders, delivering medical presentations both internally and externally in support of business development efforts. Collaborates with cross-functional teams including Sales, Marketing, and Market Access to align strategic initiatives, leads key opinion leader (KOL) engagement plans, and leads all operational and medical aspects of Pharmacovigilance (PV).Highlights:★ Leads all Medical Affairs operations including product launch readiness initiatives and serves as subject matter expert (SME) and Medical Affairs Business Lead on steering committees with key business partners.★ Spearheaded integration of Medical Affairs with Clinical and Regulatory Affairs initiatives to support life-cycle management opportunities and planning efforts.★ Directed and developed internal and external Medical Affairs personnel and created culture of KOL advocacy.★ Administered and managed Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEA), and provided operating guidance on all PV matters.★ Led post-merger activities with companies in Eastern Europe and Asia including Medical Affairs and Pharmacovigilance agreements and training, and participated in committees to establish pricing for European Union market as well as BARDA funding.

Led development of medical strategy, planned and executed Medical Affairs activities, and provided medical and scientific leadership. Developed strategic plans and budgets for Medical Information, Medical Education, and Publications functions, developed scientific communication plan for new drug launches, and served as Medical Advisor to cross-functional stakeholders including Marketing, Market Access, Sales, and Sales Operations. Presented and developed content, managed advisory boards, and led key opinion leader (KOL) engagements. Developed strategy and content for non-CME symposia during pre-approval phase, presented clinical and pre-clinical data at national meetings, and participated in safety review activities to establish Adverse Drug Reaction (ADR) list for New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions.Highlights:★ Represented Medical Affairs as part of interdisciplinary team to prepare for launch of 2 products, collaborating with Project, Launch Readiness, Brand, and Global Value teams, and serving on Labeling Committee.★ Developed Target Product profiles, aligned brand initiatives, and collaborated with Investor Relations to develop press release strategy for new drug launches.★ Served as key member of several committees including Chair of Safety Monitoring Committee, Voting Member of Compliance Committee, Co-Chair of Promotional Review and Medical Legal Review Committees, and member of Commercial Planning Committee.★ Played key role in the integration of Zavante Therapeutics after acquisition, leading integration of assets for Medical Information department, serving as subject matter expert in business development activities with prospective European marketing partners, and leading change of control documents for both Medical Affairs and Pharmacovigilance.

Directed Project Management function overseeing all aspects of development of organization’s lead product. Developed project plan in collaboration with all functional areas including CMC, Non-Clinical Microbiology, Non-Clinical and Clinical Development, Regulatory Affairs, Toxicology, Commercial, and Finance. Worked closely with C-Suite Executive Team to report and advise on clinical development for Phase III Program for lefamulin.Highlights:★ Leveraged proactive and analytical problem solving to manage key business challenges including participating in the development of Pediatric Investigational Plan focused on pediatric formulation prototype activities, and supported NDA content plan development.★ Established Chemistry, Manufacturing, and Controls (CMC) and Commercial Planning Committee.★ Developed strategic plans and budgets for Medical Publications, established Publications Strategy Team and served as Chair of team meetings, and developed Advisory Board plans, often wearing Medical Affairs ‘hat’ in this start-up organization.

Led scientific and medical content strategy including advisory boards, speaker programs, sales training, and presentations. Developed and implemented communication and publication strategy to include medical and healthcare communications, promotional medical education, and pharmaceutical marketing and commercialization. Developed SOPs and process improvements to improve operations, collaborated with cross-functional teams including Regulatory Affairs, Research and Development, and Strategic Marketing in support of business objectives. Participated in new product development, presented clinical data to medical advisory boards in the U.S. and Europe, and led the development of medical content and product training. Developed campaigns for U.S. and consulted for European markets, developed strategy and content for educational initiatives, and ensured compliance with all regulatory requirements. Developed policies and procedures in accordance with International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company Sponsored Medical Research (GPP) standards.Highlights:• Served in Medical Director capacity, managing Promotional Review, Global Project, Safety Review, and Labeling Teams, and facilitating communication with KOLs and other stakeholders.• Selected by senior leadership to direct the reorganization of Medical Affairs department after ViroPharma’s acquisition by Shire.• Established organization’s first global multi-disciplinary Publications Strategy Team responsible for developing detail plan to distribute scientific and clinical data to healthcare professionals for two products.• Served as Medical Content Expert and member of Global Project Team for CINRYZE, presenting at major meetings and U.S. and European ad boards and developing Hereditary Angioedema (HAE) KOLs.• Key member of Safety Review and Labeling Team, and served on Promotional Review committee.