PROFILES OF AVAILABLE PROFESSIONALS
Accomplished team-focused leader with the ability to thrive in early stage start-up and high growth companies. Strengths include breadth of experience; ability to connect the dots for all aspects of business; business strategy development and initiatives using lean processes and systems which enhance productivity and provide cost savings across functional areas. Exceptional communicator with ability to scale project management methodology to meet corporate needs. Entrepreneur with hands on approach; adaptable; achievement oriented; effective coach and mentor.
- Business Strategy and Planning
- Human Resources
- IS Design and Implementation
- Data Analytics
- Program Management
- Operations Management
- Corporate Policy and Processes
- Commercial Sales Force and Operations
Quality Assurance professional with extensive experience working in regulated facilities in Food and Pharmaceutical industries. Performs broad range of responsibilities, including internal department/external supplier audits; documentation review; employee training; and QA/QC management experience. Expertise in compliance and quality issues as related to cGMP, GCP, and GLP. Possesses superior work ethic and integrity and ability to consistently provide quality end results in stressful environments, including working in a Consent Decree environment. Acknowledged as “rare exception who can produce both quality and quantity of work” during review.
- Technical skills, excellent people skills, and innate ability to plan and organize.
- Natural problem solver with proficiency in root cause analysis, conflict resolution, and presentations.
- Proficient in the use of Microsoft Word, Excel, Access, Outlook, Visio, and PowerPoint, as well as ComplianceWire, TrackWise, MES, and SAP quality management systems.
Sales Leader with 20+ years of turnaround and start-up experience responsible for teams ranging in size from 10 – 100+ and revenue up to ~$500mm. Passion for people with intentional approach to engagement that retains top talent and delivers exceptional results. Inspires others to act in accordance with clear priorities to generate customer advocacy and organizational share growth. Career-long track record of success – consistently recognized and rewarded for exceeding goals as the pacesetter and innovator. Breadth of specialty launch experience includes:
- Primary Care including Rx, Buy & Bill Infusion, and Injectable
Regulatory and pharmaceutical development executive with large pharma, biotech, CRO, and consulting experience. Success driven leader with broad experience across both US and ex-US pharma and biotech industry. Career accomplishments have been noted by leading global drug submissions and approvals of several products. Led and/or participated in numerous FDA Pre-IND, Type A and B, EOP2, and Pre-NDA meetings across multiple FDA divisions. Proven Business Leader and professional with a strong record of contributions in the strategic planning and detailed execution of projects that require research, analysis, initiatives, projects and programs.
- Regulatory Strategy and Communications
- Network Direct Solutions and Cost-Effective Planning
- Discovery Research
- Global Drug Development
- Clinical Strategy
- FDA / CTMS / ICH-GCP
- Mission-Critical Business Operations
- Crisis Management vs Risk Management
Pharmaceutical executive with extensive product launch experience across rare-disease, specialty, and blockbuster therapeutic categories. Acknowledged with regular promotions for fostering a culture of commercial excellence and maintaining strategic focus among sales, marketing, analytics, and business development teams. Motivational leader who energizes teams and inspires high performance to directly impact revenue and profit.
- Strategic Vision & Execution
- P&L Management
- Product Launch Commercial Operations
- Business Development
- Start Ups & Turnarounds
Responsible for signal detection activities for assigned products, including authoring and review of signal evaluation reports. Responsible for implementation and effectiveness of Risk Management Plans for assigned products. Serves as the safety lead to development sub-team and other multi-functional teams in a matrix environment. Plans, authors, and reviews aggregate reports such as PSUR/PBRER, DSUR, IND Annual reports, ad-hoc bridging reports and REMS updates.
- Represent PV position in internal and external negotiations such as Competent Authorities.
- Lead appropriate response to health authorities’ inquiries.
- Lead coding review committee during SAE reconciliation and up-versioning of MedDRA.
- Knowledgeable in investigation of signals and running queries in health authority related databases like FDA AERS, VigiBase, BRFSS, NHANES.
- Comprehensive knowledge in analysis of Seriousness/ Relatedness/ Listedness/ Labellness of ICSRs.
- Extensive hands on experience with late case investigation – filling out CAPA forms (corrective and protective action).
Extensive training and experience in immunology, conventional and humanized animal model development. Proven track record in rapid and effective learning and problem solving. High level experience with team building and leadership, competent management of multiple simultaneous projects. Excellent communicator, effective at interacting with research, clinical, and non-scientific groups.
- PhD in Pathology/Immunology
- MSc in Immunology of Infectious Diseases
- MA in Medical and Veterinary Sciences
- General Management
- Strategic Planning
- Ex-pat International Roles
- Global Operations
- Product Development
- Joint Ventures
- Strategic Licensing
- Business Development
- Board Membership
Pharmaceutical executive with demonstrated record of achievement in leadership and executing strategies which position companies and products for rapid growth. A tested and trusted leader who builds and coaches collaborative teams to success across global markets. Consistent record of superior performance validated by measurable results and internal promotions throughout career. Proven ability to successfully launch as well as reestablish growth for underperforming Brands.
- Corporate Leadership
- Marketing Excellence
- Strategic Planning
- Product Development & Launch
- Development Organizational Management
- P&L Ownership
- Commercial Strategy & Communications
- Business Development and M&A
- Research & Development
- OTC Private Label
- Strategic Planning & Implementation
- Revenue Growth & Business Expansion
- Project Management
- Operations Streamlining
- Metric Driven Decision Making
- Financial Modeling, Analysis, & Valuation Methods
- Client Engagement & Growth
- Process Improvement
- Mentor & Team Building
- Product Line Growth & Diversification
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