Profiles of Available Professionals
A business development/strategic marketing healthcare professional with experience in the following areas: Bio-Pharmaceutical, Medical Device, Vaccine, Diagnostic, and Disease Management Technologies.
- Proven results in specialty transactions including licensing, acquisitions, divestitures, and alliances.
- Commercial assessments, based on data and insights, to define market potential and projected return.
- Success in identifying, validating, structuring, negotiating, and closing external opportunities.
- Demonstrated impact in building high performing culture internally and with external partners.
- Six Sigma Black Belt & Digital Marketing Certification.
Forward-thinking leader offering a progressive career fostering success driven cultures via the right mix of organizational programs, P&L oversight, leadership talent, and systems. Fully engages with matrixed teams and the Board of Directors to scale businesses through astute operational improvements that have produced sustainable growth. A natural leader who innovates, inspires, and creates impact via a strong visionary outlook.
- Corporate Strategy Implementation, Multi-year Planning
- Multi-site Leadership, Culture Building
- Cross Market Plans, Customer Experience Strategy
- P&L Leadership, Program & Policy Execution
- Negotiator, Influencer, Change Facilitator
- Acquisitions, New Openings, Corporate Downsizing
- Talent Development & Building Future Leaders
An award winning and innovative Senior Sales Leader with over 15 years of experience in the diagnostic and pharmaceutical industries. Results oriented, with a proven track record of building high-performing teams by capitalizing on diverse experience and expertise in sales, sales management, managed care, sales training and development, and sales operations. A dynamic team leader with the ability to translate corporate vision into the tactical plans and performance expectations that front line sales people can execute against. A proven ability to create a collaborative, performance based culture that rewards results, and sets a high standard for professional growth and development.
- Strategic Leadership
- Building Commercial Teams
- Performance Management
- Cross Functional Integration
- Business Acumen Training
- Sales Force Effectiveness
- Communication/ Platform Skills
- Formalizing Career Development
- Business Intelligence & Analytics
- Managed Care/Markets
- Professional Development
- Incentive Comp Design
- KOL/Advocacy Development
- Personalized Medicine Positioning
- Unique Product Launch Expertise
Exceptional analytical, problem solving and leadership skills which have developed over 15 years in the Medical, Pharmaceutical, and Biotech fields. Medical expertise for safety data management and communications, including individual case assessments, aggregate reporting, safety-related label changes, and signal detection evaluation and management. Provide expert medical safety input to company core safety information and clinical development programs (Clinical Trial Protocol, Clinical Trial Report, Post-Authorization Safety Study, Risk Management Plan and developmental RMP’s, Safety Assessments).
- Accountable for all aspects of serious adverse event reporting for investigational and marketed products and medical case review in ARGUS and EMPIRICA.
- Thorough knowledge of FDA regulations related to Medical Device Reporting and Adverse Drug Experience Reporting.
- Provides input and medical opinion regarding content of safety aggregate reports (PSURs, PADERs).
- Provides input on post-marketing experience for registration/RX to OTC switch/renewal dossiers and to Health Authority queries.
- Coordinates and streamlines communication to the field organizations on strategies, tactical plans and action items in an effort to optimize execution.
- Experience with regulatory writing including, Clinical Study Protocols, Informed Consents, SOPs, Safety Narratives, INDs, PSURs, NDAs, regulatory responses, patient safety narratives and other clinical/regulatory documents.
- Knowledge of ICH, FDA, and EU guidelines and regulations.
A highly accomplished results-oriented procurement supply chain executive with an MBA and engineering undergraduate degree coupled with more than 20 years’ experience in the following industries: consumer packaging goods, biologics industry, financial services, national electrical supplies distribution, electrical energy provider, oil & gas industry. Core strengths include leading teams in the following areas of focus:
- Indirect & direct procurement
- Supply chain management
- Contracting excellence while strengthening the strategic alignment of cross-functional business partners
Life sciences commercial executive with 20 years of experience in commercialization of assets from the preclinical to transition to launch teams, and in business development. Extensive track record in orphan and chronic diseases. Hands-on, energetic, yet collegial team member who can help create a commercial vision for emerging assets and develop the operational plans to maximize value for public and private companies.
- Harvard Business School: Executive Education Seminar in Competitive Negotiation Yale University: MBA election in Corporate Finance
- Drew University: BA Political Science
Top-performing business development professional with a consistent track record of closing in- and out-licensing deals and alliance management.
- Extensive deal structuring, negotiation and due diligence experience.
- Deeply experienced in opportunity assessment including markets, products, clinical development, business operations, financial analysis, and IP.
- Expertise in global drug development management across novel biologics, NCEs, biosimilars and specialty generics.
- Talented technology scout across a broad range of specialty pharmaceutical areas, most notably in Oncology, Immunology and Diabetes.
Over 30 years of experience working in clinical research with over 26 years of experience in business development and clinical product development. Clinical Research Therapeutic Areas include: Early Phase Clinical Trials, Ophthalmology, Medical Device, Infections/Vaccines, Endocrine/Metabolic, Oncology and Antiviral.
- Senior biotech and medical device executive
- Product and medical device development
- Directly involved with NDA and PMA approvals
- Post marketing communications
- Brand extensions
- FDA labeling surveillance
Extensive, broad-based experience with increasingly challenging assignments in privately held and publicly traded mid-market manufacturing and distribution organizations. Operationally oriented financial executive with a proven record of successfully streamlining operations and increasing profits. Background includes managing the information technology, human resources and procurement functions. Recent experience with private equity ownership. Expertise in:
- Cash management
- Bank financing
- Financial reporting and analysis
- Strategic planning
- Mergers and acquisitions
- Process improvements
- Software conversions
- Cost accounting
- Profitability analysis
Results-driven leader with 15 years experience in healthcare, 10 of which were in digital health. Core competencies include management, product innovation, strategic planning, business development, and developing strategic partnerships. Initiated, launched, and exited healthcare ventures; and lead technology commercialization and venture development efforts for universities. Passionate about innovation and entrepreneurship; opportunity identification; and leading for organizational growth, and coaching for a ‘can-do’ attitude. Experienced account manager, and in management of research, development, engineering and operations of technology organizations from concept to advanced product/service development through product support. Active in several local and national organizations; mentor for operational and strategic planning for early-stage companies; and invited speaker on subjects ranging from “entrepreneurship” to “doing business with the government.”
- Digital Health
- Medical Device
- Data Analytics
A rare diseases expert and a pioneer in the field of applied theranostics for the development of disease-modifying treatments. A board-certified Neurologist with a Ph.D. in Pharmacology and more than 20 years of drug development expertise in the pharmaceutical industry and academia.
- Started clinical practice activity in 1994 with specialist clinics in Europe and continues involvement providing targeted management of patients with rare neuromuscular disorders.
- Founded an IP holding company and an innovative contract-leadership company.
- Directed successfully a number of clinical development and medical programs across several therapeutic areas, as well as contributed to licensing/acquisition activities and strategic therapeutic positioning of assets.
- Led global medical/clinical departments successfully, leading clinical translational and late-stage programs, launches, and registrations of several products.
Medicine Development Leader with demonstrated ability to design and direct registration program activity in multiple indications, including: rheumatoid arthritis, psoriasis, inflammatory bowel disease (ulcerative colitis and Crohn’s Disease), ankylosing spondylitis, atopic dermatitis, osteoarthritis, irritable bowel syndrome, post-operative ileus and opioid induced constipation.
- “Hands-on” management style of both line and matrix teams, direct to achieve translation of clinical hypotheses into medical communications plans and Phase 2-4 registration programs.
- Expertise in development of surrogate markers of efficacy and safety for registration and innovating methodology to enhance understanding of benefit to risk proposition.
- Design and conduct of outcome studies for post marketing requirements and negotiation of REMS.
- Global Regulatory expertise including negotiations with FDA (SPA, End of Phase 2, NDA and presentation at Advisory Committees), CHMP and PMDA.
- Excellent communication skills - Creation of Medical Affairs strategies (in collaboration with Commercial and Marketing teams) and communication with internal and external stakeholders through all phases of a medicine’s lifecycle.
Clinical Research Professional with demonstrated success in Clinical Research and Project Management whose experience includes mentoring internal and external team members into high achieving professionals while integrating business and regulatory needs. Serves as an advisor and leader in designing, implementing, and closing large-scale projects, specifically clinical trials for all phases of development. Proven strategic leader who motivates high performing colleagues to exceed corporate objectives and to perform pioneering work in complex, global, and matrix organizations.
- Strategic Business & Operational Leadership
- Business Operations & Regulatory Integration
- Therapeutic experience in Pain, Infectious Disease, Critical Care, Cardiology, Respiratory, Nephrology, Urology, Transplant, Surgery, CNS, and Women’s Health
- Clinical Research & Development
- Medical Affairs Expertise
- Phase I, II, III and IV Trial Design and Execution
- High-Performing Team Management
- Process Improvement
- Scientific Presentation
- MBA, Leadership & Entrepreneurialism
- BS, Environmental Science