Multifaceted C-suite executive with contagious enthusiasm, respected for elevating brands and maximizing consumer loyalty through groundbreaking growth strategies, lean operational processes, and remarkable business transformations. Quick to identify untapped opportunities and deliver innovative solutions that drive millions in revenue. History of producing immediate results upon entering highly competitive markets. Known for re-evaluating current practices, stopping ineffective patterns, and pushing organizations outside their comfort zones to achieve tremendous results. Extensive success in building, coaching, motivating, and leading top-performing teams. Willing to relocate.

  • Unprecedented Profitability
  • Organic & Inorganic Growth
  • Corporate Turnarounds
  • Robust Sales Channels

Agile, influential executive with 20+ years of success in igniting business, sales, and market share growth in fiercely competitive corporate sectors during periods of healthcare breakthroughs and reforms. Adept at navigating complex market dynamics involving GPO, IDN, LTC, ACO’s, MCO, Medicare Part B and D, State Medicaid, and VA/DoD reimbursement. Effective at identifying, developing, and motivating high-performance field leadership teams.

  • National & Regional Account Management
  • Strategic & Tactical Planning / Execution
  • New Business & Market Development
  • Trends Analysis & Competitive Analysis
  • C-Level Executive Negotiations & Closings
  • Marketing, Contracting & Pull-Through Strategies
  • Product & Company Launch
  • Regulatory, Legal, Compliance & Reimbursement

Senior physician-scientist (M.D., Ph.D.) and drug development executive with over 30 years of diverse experience in the biotechnology/pharmaceutical industries. Involved in the clinical development and approval of 17 drugs, with three years’ experience in academic medicine as an associate professor at UCLA. Manages small biotechnology and mid- to large-size public pharmaceutical companies, including all aspects of drug development and medical affairs operations, such as pre- clinical pharmacology and toxicology; Phases I-II clinical development; Phase III pivotal trials; as well as Phase IV and market support activities, including management of clinical risk/benefit, pharmacovigilance, and medical information, on a global basis. Extensive experience with buy- and sell-side analysts and investment bankers in framing medical need and delivering corporate presentations of clinical data. Reputation for excellent managerial, motivational, problem-solving, and planning skills, achieving goals and objectives. Files NDAs/MAAs and supports the launch of new products. Negotiates face to face with FDA/EMA and through written correspondence with health authorities worldwide. Areas of medical training/expertise include:

  • Gastroenterology and Liver Diseases
  • Oncology
  • Allergies
  • Respiratory Diseases
  • Cardiovascular Diseases
  • Osteoporosis
  • Women’s Health
  • Endocrinology
  • Diabetes
  • Metabolism
  • Rare and Orphan Diseases

Scouting and evaluation of business development opportunities including scientific evaluation, competitive landscaping, and formal due diligence. 125+ business development assessments to date. Devised upstream and downstream marketing strategy and implementation plans. Assessed the clinical economic value of medical devices designed for diverse therapeutic applications for business development deals and venture investments. Devised clinical development programs for phase IIA to IV cardiovascular disease assets.

  • Master of Business Administration
  • Doctor of Medicine
  • Master of Philosophy: History and Philosophy of Science
  • Bachelor of Science: Physiology

Innovative & self‐motivated professional with extensive experience of approximately 8 years in programming, process improvement & implementation, team management, project management & managing large‐scale projects from requirements gathering to completion. Demonstrated track record of successfully managing small to large projects from start to finish. Highly skilled in tracking details, communicating deadlines, & following‐up with internal & external partners to ensure on‐time completion. Ability and interest in learning & incorporating new technology. Consistently receive positive feedback from managers, co‐workers & clients.

  • All phases of clinical trials & drug development process
  • Clinical data management process flow
  • Pharmacovigilance process flow
  • Regulatory affairs
  • ICH-GCP, Schedule Y & ICMR guidelines
  • SDTM, CDISC/ CDASH Standards
  • Clinical Study Reports (CSR) and submissions

Bio Engineering graduate with 7+ years professional experience of working with various sponsors, CROs, IT companies, and faced many local regulatory audits. 4+ years of experience as a Clinical Team Lead in Risk Based Monitoring & Clinical Operations.

  • Managing team of 70+ global resources (CRAs, Central Monitors, CTAs, PAs) & responsible for entire Clinical project management of trial.
  • Reviewed around 300 monitoring visit reports & have performed more than 200 site visits inclusive of site qualification, site initiation, site monitoring, site QC visit and close-out visit.
  • Strong background in various therapeutic areas like Neurology, Endocrinology, Nephrology, Hematology, Cardiovascular, Ophthalmology, and Gastrointestinal.
  • Expertise in the selection of CROs, vendors, contractors and sites.
  • Skilled in training and knowledge of regulatory laws.
  • Process oriented, creating SOPs, Work Instructions and following ISO guidelines to deliver quality to the clients.
  • Total Global Clinical Trials worked till date – 15. Managed RBM Operations of 45 countries at a time in multiple projects.

Experienced medical device product development leader with expertise in structuring for success, aggressive R&D predictability improvements and product and process quality improvements. Successfully led product line remediation and full Design Controls re-engineering in two businesses. Implemented cross-functional product development and business line portfolio management processes in multiple businesses, resulting in consistent on time, on-quality new product introductions. Experienced in creating, growing, empowering and re-organizing high performance cross-functional product development organizations. Experienced innovation leader, with a strong record of building and managing technology innovation funnels to support long range portfolio planning and risk-reduced product development.

  • User Based Innovation
  • Leading Cross-Functional Product Development
  • Customer Management
  • Global R&D Management
  • Strategic planning & growth
  • Program & Portfolio Management
  • Project Management
  • FDA design controls
  • Process Re-Engineering
  • DFSS integration
  • Regulatory compliance

Medical Affairs professional and M.D. with 3 years of experience in the Pharmaceutical and Biotechnology industries. Exchanges scientific and medical information with physicians and managed care (MC) organizations. Drives pharmacoeconomic value vis-à-vis research initiatives, including: Health Economic and Outcomes Research (HEOR), Investigator Initiated Trials (IIT), and publication strategies. Optimal territory management and organizational skills; including effective operation under full consideration of industry and corporate specific guidelines on compliance standards and regulations. Leverages relationships with Key Opinion Leaders (KOLs) to advance corporate goals in Therapeutic Areas of industry experience, including:

  • Cardiology
  • Neurology
  • Pulmonology
  • Immunology

Clinical Quality and Compliance Executive offering 20 years of corporate leadership success. Strategic and innovative thinker experienced in development and deployment of management controls, process governance, and quality and compliance systems in diverse business environments and cultures. Excellent understanding of regulatory requirements, pharmaceutical Good Clinical Practices (GCPs) / ICH and 21 CFR Part 11, and leveraging this understanding to enhance clinical trial and software R&D operations. Experienced in managing group and individual efforts to leverage technology to improve quality and efficiency. Strong business command focusing on the customer.

  • Quality Operations
  • Strategic Business Planning
  • EDC/eCRF, RTSM, CTMS, Supply Chain, Safety and Financial Reporting
  • Global Process Development
  • Regulatory Auditing
  • IT Processes, Qualification, and Change Management
  • Software Development and Validation
  • Employee Training
  • Risk and Incident Management
  • ISO 9001 and SOC Certifications

An accomplished CEO and leader who has used breadth and depth of experience to produce notable success in healthcare services and information technology companies. Objective as CEO, is to lead a healthcare services company to achieve optimal results for employees, customers, suppliers, and shareholders.

  • Healthcare
  • Information Technology
  • Operations
  • Sales & Marketing
  • Business Development
  • Growth Strategy
  • Reorganization & Transitions
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Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Suite 214
Wayne, PA 19087

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