Pharmaceutical Research Physician Consultant: Clinical Research, (Phase 2-4), Regulatory Affairs-Filings, Life-Cycle Management and Launch Activities

Expertise

• Review of digital and non-digital Advertising and Promotion materials for existing brands, as well as new product launches, (U.S. and international) press releases, educational materials, sales rep training, OPDP, (Office of Prescription Drug Promotion) regulations.
• Life-cycle management and new product launch activities, including:Advisory boards, KOL development, presentations at medical conferences, symposia, advertising and promotion materials, press releases, internal company communications.
• Design of clinical research programs; Phase II, III, IIIb, and IV.
• Review of clinical documents, including: Investigator brochures, protocols, clinical study reports, publications, abstracts, presentations, and investigator meetings.
• Company replies to regulatory questions.
• Labeling language proposals.
• Negotiation with regulatory agencies worldwide to obtain best possible approval for products.
• Cross-functional and cross-divisional teams defining program direction and strategy for various therapeutic areas.

Experience

Undisclosed Company, Senior Medical Director, Global Medical Affairs, 2011 - 2014

• Served as a medical expert with regard to advertising, promotion, medical information, press releases, and educational activities in U.S. and international regions.
• Helped define the medical promotional strategy for brands and product launches.
• Collaborated cross-functionally with clinical research, commercial business unit leaders, international and external affairs, regulatory, legal, and compliance teams to ensure that all promotional and educational activities are coordinated and consistent.
• Guide teams to ensure sales training and promotional pieces are medically and scientifically correct and consistent with labeling, and that comparisons to other products are scientifically valid, fair, balanced and fulfill regulatory and legal requirements.
• Extensive knowledge of OPDP, DDMAC, (Division of Drug Marketing, Advertising and Communication) and other regulatory guidelines that govern product claims, advertising, and other promotional considerations.
• Acted as a senior company representative interacting with external scientific leaders (including Advisory Boards) and, or regulatory authorities.
• Collaborate with global therapeutic area scientific lead, research and business unit leaders, International Medical Director and external affairs, regulatory, commercial, compliance, and business unit management teams to ensure that all promotional and educational activities are coordinated and consistent.
• Provide medical guidance in support of brands and product launches in the GI and Renal Franchises.
• Review and approve promotional materials and activities, and provide medical and scientific input and approval for commercial and press releases for the GI and Renal Franchises.
• Assure conduction of appropriate steps to support therapy area business unit and commercial teams in crafting and utilizing core claim guides and balance (ISI) documents.
• Guide teams to ensure sales training and promotional pieces are scientifically correct and consistent with labeling, and that comparisons to other products are scientifically valid, fair, balanced and fulfill regulatory and legal requirements.
• Provide medical input for the distribution of scientific and medical information to effectively provide accurate, quality, and up-to-date information to internal and external customers while meeting appropriate legal and regulatory requirements.
• Remain up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge, and ensure consistent best practice across all activities.
• Provide medical information support for marketed products in GI and Renal Franchises
• Interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
• Adjudicate issues regarding medical approval of promotional activities.
• Help maintain zero tolerance for FDA untitled and warning letters by participating in internal audits of promotional material and other quality improvement initiatives across all brand teams.

Merck, Rahway, NJ, Senior Director, Medical Affairs, 2010 - 2011

• Provided strategic and tactical input for the development of new, innovative strategies, communications, promotional and educational materials for products in the respiratory, allergy, vaccine, and diversified brand franchises.
• Provided medical leadership in support of the global medical and marketing communities and other clients and customers worldwide on issues of early strategy development, lifecycle management processes, and support implementation of global and regional medical and scientific strategy.
• Designed, reviewed, guided and implemented medical promotion, and medical communication for physicians, key opinion leaders, and patients in compliance with regulatory and internal company standards while ensuring scientific and medical accuracy.
• Developed and reviewed material for internal medical education needs and developed disease education and other educational programs for external customers (patients, health care professionals, medical experts, KOL, and scientific leaders).

Senior Director, Regulatory Affairs and Labeling, 2006 - 2010

• Leader of multiple cross-functional and cross-divisional teams in charge of defining and negotiating best possible labeling language.
• Provided strategic direction for labels in various therapeutic areas; infectious disease, endocrinology, internal medicine, respiratory disease, oncology, neurology, psychiatry, and vaccines) to ensure consistency within the company and within each therapeutic area.
• Ensured cross-functional consensus, as well as accurate and up-to-date medical and scientific content of 90 product labels worldwide
• Clinical Liaison, advisor and internal expert for label language requirements for products in various stages of development, (i.e. pre-launch, marketed promoted or in-line products)
• Collaborated cross-functionally and provided strategic guidance for VLAD, (Value and Label as Driver) teams, thereby ensuring best possible clinical development and life-cycle development programs to obtain desired labeling language.
• Designed, reviewed, guided and implemented medical promotion, medical communication, and medical education materials for physicians, key opinion leaders, and patients in compliance with regulatory and internal company standards while ensuring scientific and medical accuracy.

Assistant Director, Associate Director, and Director, Clinical Research, 1996 - 2004

• Served various positions in numerous locations at Merck; United Kingdom, PA, and others. Functioning in a variety of leadership roles within clinical research, neuroscience and ophthalmology franchises for:
• Head Clinical Neuroscience Department, United Kingdom.
• Head Clinical Neuropharmacology Department, U.S.
• Head Ophthalmology Department in U.S.
• Leader of the migraine product development team.
• Core member of the migraine worldwide business strategy team.
• Internal clinical expert for migraine.
• Clinical monitor for Phase II, III, IV and V clinical trials in a variety of patients with ages ranging from 2 week old infants, adolescents, adults to elderly.
• Authored various sections, and filed 3 original regulatory filings (2 WMA's and 1 INDA).
• Authored and supervised several expert reports for supplemental filings and Type II variations in order to obtain label changes of existing products.
• Designed, conducted, analyzed, published and presented the design and results of various clinical trials in peer-reviewed journals, medical conferences and advisory boards.
• Pharmacovigilance: reviewed adverse event reports of several marketed products and took appropriate actions.

Sanofi-Aventis, Bridgewater, NJ, Vice-President, Global Strategy Development, 2004 - 2006

• Managed 7 direct reports and 200 indirect reports in the U.S.A. and France.
• Defined the strategic development (pre-clinical to Phase V) and life-cycle management of compounds within the complete neurology portfolio of the company (Alzheimer Disease, Parkinson Disease, Multiple Sclerosis, and Spinal Cord Injury).
• Defined the strategic development of compounds in other therapeutic areas including psychiatry (alcohol dependence, smoking cessation), internal medicine (Type II Diabetes mellitus, obesity, Metabolic syndrome), urology (urinary urge Incontinence), and oncology (chemotherapy induced sensory peripheral neuropathy).

Senior Director, Global Product Team Leader, 2004

• Managed over 30 indirect reports in a matrix organization.
• Defined strategy and life-cycle management for an oral CNS compound under development for MS, (Multiple Sclerosis).
• Leader of a global cross-functional, cross-divisional team of scientists, managers and executives working in the following areas: Preclinical research, toxicology, pharmacokinetic and pharmacodynamic research, clinical research, pharmacovigilance, regulatory and labeling, commercial and marketing, finance, legal and patent, and (PPPM), Productivity, Portfolio and Project Management.

Honors & Publications

Languages

• English (fluent)
• Dutch (native tongue)

Academic and Professional Affiliations

• President - Annual Scientific Meeting Medical Society "Sir Alexander Flemming."
• Local Committee Member - 2nd Congress European Headache Federation, Liege, Belgium
• Dutch Association for the Study on Headache-DASH

Research

• Successfully set-up, managed, and grew a new internship department at Leiden University for medical students conducting research.
• Designed, conducted, analyzed, presented, and published various scientific projects in clinical research, and epidemiology for the area of neurology (focus on migraine).
• Clinical Investigator for Phase IIa, IIb, and III clinical trials.
• Managed a team of up to 17 medical students.
• Consultant, migraine expert, invited speaker, and press conference speaker for several pharmaceutical companies such as Merck, GlaxoSmithKline, Wellcome, Pfizer and AstraZeneca
• Clinical Research Physician (Neuroscience), Center for Human Drug Research, the Netherlands
• Designed, conducted, analyzed, presented, and published various scientific projects in clinical pharmacology and imaging research (SPECT, Doppler) for the area of neurology (focus on migraine).
• Clinical Investigator for Phase I clinical trials.

Awards

• Shire Award of Excellence: Best Digital disease state, and promotional website development for patients.
• Shire Award for Making a Difference: Best and company-first iPad design for use in promotion to HCPs in US and ex-U.S.
• Merck Marketing Award: "Brand of the Year Finalist" for promotion and medical communication/education materials.
• Merck Award of Excellence: Negotiated successfully with regulatory agencies worldwide to obtain new indications and desired labels.
• Merck Award of Excellence: Defined and implemented best strategy for Migraine Franchise within the company, from pre-clinical to life-cycle management.
• Merck Award of Excellence: Collaborated cross-functionally and defined strategy with Medical Affairs & Marketing for pre-launch, launch, and post-launch activities of migraine product.
• Merck Appreciation Award: Designed, reviewed, guided and implemented medical promotion, medical communication, and medical education materials for physicians, key opinion leaders, and patients in compliance with regulatory and internal company standards while ensuring scientific and medical accuracy.

Publications and Patents

• Author and Presenter of over 70 peer-reviewed publications, book chapters, abstracts and oral presentations.

Education

• Ph.D. Neuroscience, Leiden University, Human Drug Research, Leiden, The Netherlands
• M.D. General Medicine, Leiden University, Leiden, The Netherlands
• Pharm.D. Pharmacy-Propaedeutics, Leiden University, Leiden, The Netherlands