FEATURED

PROFILES OF AVAILABLE PROFESSIONALS

Physician / Surgeon with 20+ years of experience as a clinician, medical researcher and a management executive. Successful track record of providing medical leadership, building and implementing strategic plans, driving innovation, and managing professional teams.
  • Global Head, responsible for planning and execution of worldwide medical affairs strategy to support $2.7 B Medication Delivery and $2.1B Pharmaceuticals business units.
  • Managing 4 clinical studies to support product development and regulatory strategy.
  • Medical Affairs lead on recent acquisition. Core team member of the Innovation team supporting scientific evaluation of external R&D, business development and M&A opportunities.
  • Leading a team of 15 professionals – MDs, nurse practitioners, pharmacists. Managing a budget ~ 1.2M.
  • Provide medical leadership and recommendations to support new product development, medical education, risk assessment, clinical evidence generation / publication planning, clinical trial strategy, regulatory submissions, professional education / scientific exchange, build customer / KOL relationships, support investigators research, etc.
An experienced Drug Safety/Pharmacovigilance/Regulatory Writing professional with 9.5 years of relevant experience with top pharma/biotechnology firms worldwide. Significant experience in authoring and reviewing all safety regulatory document types (e.g., PSUR/PBRER, DSUR, PADER, CAR, ACO, RMP etc. and ad hoc safety responses to various Drug Regulatory Authorities). Quality Control of CSRs, IB, briefing documents, RTQ’s, RMP’s, REMS, PRAC RTQ’s, Safety Assessment Reports and clinical overview documents.
  • Signal Detection Activities: Assist Safety Risk Lead in analyzing safety signal data retrieved from the signal detection tool and literature review and discuss the results with the TAH, SRL, and other key stakeholders.
  • Mentoring, training and coaching new employees on ICH regulations and company SOPs.
  • Business process improvement: Developed QC score card: tool for RCA and CAPA.
  • Hands on expertise on various drug safety databases such as Argus, ArisG, Sapphire and tools such as EPIC and GDMS. Proficient in MedDRA coding, ICSR (including medico-legal case) processing and narrative writing.
  • Lean Six Sigma Green Belt trained professional adept at applying the principles of Six Sigma. Actively involved in Project management related activities including TCS Integrated Quality Management System.
Highly accomplished, versatile and respected professional presenting with over 17 years of extensive accomplishments within diverse environments in industry (Pharma, Medical Device, and Nutrition) and in academia (Medical Centers, University Hospitals, Clinics, Hospice), utilizing exemplary management, analytical, organizational, and people skills. History of accepting full accountability for divisional direction and strategic management, development of new services and operations, and revenue performance and enhancement strategies. Dynamic leader consistently achieving outstanding results in challenging environments while building and maintaining strong, loyal relations with both clients and colleagues. Moves and relates effortlessly across all levels of management. Broad based qualifications include:
  • Broad leadership and clinical research trials experience in various therapeutic areas with leading pharmaceutical, nutrition and medical technology companies.
  • Previously trained healthcare provider turned Research Scientist/Administrator for the past 15 years with clinical practice in Internal Medicine with sub-specialty training in Oncology/Hematology. Over 10 years diagnosing, controlling and treating the following symptoms: prostate cancer lung cancer, solid tumors, lymphomas, leukemia, breast cancer, ovarian cancer, cervical cancer and prostate cancer.
  • Lead medical trials in medical studies from preclinical to first in-human clinical trials (Phase Ib/IIa/III including IND and NDA/BLA filings) and research addressing major medical issues.
  • Broad based technical expertise to lead the development of generic and proprietary pharmaceutical products.
Experienced chemical development leader with a history of success leading teams of multifunctional scientists with a key focus on drug development. Strategic emphasis on enabling the discovery, development, scale-up, and technical transfer of API (Active Pharmaceutical Ingredient) manufacturing processes that deliver clinical supplies and, ultimately, commercial API. Proven ability to lead all aspects of science on development projects, delivering on time and within budget. Demonstrated leadership, communication, and motivational skillset, with the following areas of expertise:
  • Process Chemistry
  • Engineering
  • Drug Substance & Product Supply
  • Project Management
  • Risk Analysis
  • In-Licensing Team Leadership
  • Tech Transfer
  • Clinical Trial Supply
  • Compliance
  • Quality & Safety
  • Strategic Planning
  • Recruiting
Diplomatic, persuasive pharmaceutical executive with record of generating sales, building product portfolios, and expanding corporate value. Experience negotiating and closing deals including national account sales, licenses (product), acquisitions (product / corporate), and legal settlements. Deep understanding of the pharmaceutical market from sales, business development, and legal perspectives.
  • Juris Doctor (JD)
  • Master of Business Administration (MBA)
  • Bachelor of Science (BS)
An accomplished leader with 20 years of world class pharmaceutical experience in a variety of dosage forms associated with both Rx and OTC drug products. Leads through influence and inspiration, proven dot connector, culture and change champion. Proven leadership in Quality Assurance, cGMP Manufacturing, Product Development/Technical Services, and Technical Operations. Led the technical transfer of dozens of both internal and external projects in various stages of development through commercialization. Helped to establish and apply a stage gate process to the development of individual projects.
  • Designated site decision-maker for Operational Quality and Development.
  • Accountability for site Quality Management Systems and compliance with site procedures and global regulations.
  • Ensures all commercial and pre-commercial products released to the US and worldwide markets are in compliance with current GMPs and regulations.
  • Provides support for worldwide regulatory site inspections.
  • Reviews CMC sections of IND, NDA, ANDA, and other global regulatory submission documents in support of clinical trials and marketing applications and deficiencies.
  • Extensive knowledge of ICH and ISO requirements, and experience in preparation and submission of documentation to support investigational and marketing registrations to worldwide authorities.
Strong business leader with over 19 years of experience in rare diseases, oncology and digital health across various commercial roles, company sizes and markets. Proven track record of exceeding targets, value creation, corporate and business development, strategy development and implementation, product launches and brand management, sales, market access and commercial operations. Skilled in formulating, evaluating and implementing successful strategies for highly specialized products. Focused on improving organizational performance through cross-functional collaboration.
  • Able to align systems, people, resources, processes, policies and culture to achieve goals.
  • Board and executive leadership team experience.
  • Strong motivator who effectively shares vision and leads by influence, inclusion and transparency.
  • Advanced science and business training, and passion for excellence in both.
  • Driven by integrity, innovation, performance and adding value to the patient, medical and investment communities.
Extensive background in pharmaceutical Corporate Strategy, Strategic Planning/Business Planning, Commercial Operations and Corporate/Brand Strategy. Worked directly on enterprise-wide and cross-functional business operations, innovation and transformation initiatives including strategy development, M&A/merger integration, business development, commercial launch/growth, corporate turnaround, business restructuring and organizational design. Eight years’ experience driving Pharmaceutical PMOs, working on key corporate strategic initiatives. Served as Chief of Staff to Pharmaceutical CEOs/COOs/Executive Team for six years; building and maintaining credibility with C-Suite/Executive Management as a result of consistently exceptional performance and leadership of strategic projects across functions and organizations.
  • Accomplished in the functions of Corporate Strategy/Strategy Development, Business Planning, Business Development/M&A, Restructuring & Merger Integration, Internal Consulting, Business Operations, Marketing and Sales, on both a US and global basis.
  • Highly proficient in project management, process improvement, presentation development, Executive meeting design/execution/follow through and corporate communications.
  • Native English speaker, proficient in German, knowledge of French and Spanish. Dual Citizen: US & EU.
  • Strong leadership, negotiation and team-building/team facilitation skills, with ability to work in highest levels of confidentiality with integrity, diplomacy and tact.
Managed 18 employees in the Commercial QA Manufacturing group, R&D QA Manufacturing group, and QA Product Release group. Performed final review and disposition for process validation protocols and reports, master manufacturing records and SOPs. Served as Inspection Readiness core team member; was responsible for walk-through inspections. Prior to new positions being added, chaired the quality review board meetings, managed QA Raw Materials group and owned the commercial TrackWise system for production deviations and CAPAs. Performed review and final disposition of production deviations for site and contract packagers and issuance and closure of CAPAs.
  • Implemented TrackWise system for deviation and CAPA modules; provided hand-on training to super users.
  • Created the quality review board and developed metrics for compliance measurement.
  • Identified opportunities for improvement and performed failure mode and effects analysis (FMEA).
  • Created an umbrella protocol procedure to unite multiple fragmented protocol systems.
  • Improved QA sampling and inspection procedures.

Ten years of success leading scientific, medical and clinical affairs in diagnostics (IVD) industry. Focused on developing medical value for novel clinical diagnostic solutions in global environment. Talent for establishing productive partnerships, scientific collaborations and business alliances. Broad scientific and medical expertise with significant contributions including peer-reviewed publications, conference presentations and active membership in major professional organizations. Visionary, strategic thinker with entrepreneurial spirit driven to discover and develop innovative diagnostic products that address unmet medical needs and achieve business goals.

  • Scientific & Medical Affairs Strategy
  • Biomarker Clinical Development
  • Post-market Evidence Development
  • Thought Leadership, Strategic Alliance and Partnerships
  • New Product Development Process and IVD Regulations
  • Technology Assessments
  • Market Access / Reimbursement
  • Team Leadership
  • Strategic Business Planning
  • International Scientific & Business Experience
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CONTACT ASHTON TWEED FOR MORE INFORMATION ON TALENT

Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
314 S. Henderson Rd.
Suite G370
King of Prussia, PA 19406

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