PROFILES OF AVAILABLE PROFESSIONALS
- 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.
- 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.
- 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.
- Process Chemistry
- Drug Substance & Product Supply
- Project Management
- Risk Analysis
- In-Licensing Team Leadership
- Tech Transfer
- Clinical Trial Supply
- Quality & Safety
- Strategic Planning
- Juris Doctor (JD)
- Master of Business Administration (MBA)
- Bachelor of Science (BS)
- 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.
- 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.
- 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.
- 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
MORE PROFESSIONALS IN OUR TALENT BANK
CONTACT ASHTON TWEED FOR MORE INFORMATION ON TALENT
Phone: (610) 725-0290
Fax: (610) 975-0291
Ashton Tweed, Ltd.
314 S. Henderson Rd.
King of Prussia, PA 19406