Medical Affairs leader with experience in global and US markets for the pharmaceutical/biotechnology industries. Demonstrated intellectual agility to contribute substantially in multiple leadership positions and therapeutic areas, including: internal medicine, primary care, infectious disease, vaccines, women’s health, endocrinology, and oncology. Marketing & Commercialization Support Clinical Trials | Phase I to Phase IV Regulatory Alignment & Strategy Investigator Initiated Research Medical Promotion | Medical Education Key Opinion Leader Interaction Medical Publications High Performance Team Development
Medical Director, US Medical Affairs
Since January 2014
Medical Director, US Medical Affairs Oncology * Medical input into key clinical brand activities including clinical trials, Real World Evidence (RWE) * All activities of study team physicians for US local trials including design of trials, medical oversight of trial conduct, data interpretation * Ascertaining the medical accuracy of medical information in promotional material and learning materials for both internal and external use Responsible: * Medical input into brand strategy * Interact with leaders of groups identified as strategic partners, including both payer and provider groups. * Interact with leaders in the therapy area (KOL, Academic Institutions, Societies). * Play an integral role in the planning and participation of national and regional medical advisory boards. * Play an integral role in the planning and providing of training for external medical/scientific speakers. * Provide clinical education and training for internal stakeholders such as regional scientific managers and members of product sales teams. * Provide medical review in concert with cross functional team members for investigator-sponsored research proposals. * Provide medical input into the Brand Team Investigator Sponsored Studies (ISS) program and Publication Strategies * Maintain key links into global brand clinical activities by maintaining collaborative working relationship with TA medical physicians including Medical Science Director (MSD), Clinical Research Scientists. * Supply medical input into safety profile of the product in collaboration with Patient Safety (PS) physicians * Act as medical spokesperson for US Brand as needed for media inquiries or other external groups.
Senior Medical Director | Team Leader | US Medical Oncology
January 2011 --- January 2013
Appointed US Medical Affairs lead for Sutent® (sunitinib), an anti-cancer drug, with a team of 3 direct reports (2 MDs, 1 PhD). Provided support for clinical trials (Phase I to Phase IV), protocol development, Key Opinion Leader (KOL) interaction, investigator initiated research, and publications. • Accountable for successfully delivering and implementing an overall tumor strategy for Sutent®. Harmonized clinical, development and commercial strategy to maximize benefit to the patient and Oncology Business Unit. • Regional point of contact for KOL engagement and relationship management. Created kidney cancer symposium for external academics and Pfizer Oncology medical. • Key member and active participant in design of strategic development plan to support the brand strategy and life cycle for Sutent®. Aligned Sutent® strategy with other Pfizer products for renal cell carcinoma, as well as for future products. • Led medical review of promotional and advertising strategies. • Created medical education goals specific for renal cell carcinoma and other indications for Sutent®. Ensured alignment of funded education programs towards the Sutent® strategy and all of global medical oncology. • Formulated publication strategy and effectively implemented with impactful publications above plan.
Senior Medical Director | Global Medical Oncology
January 2007 --- January 2011
Chosen to join the growing ‘invest to win’ Oncology Business Unit providing key medical expertise for inline and pipeline oncology products. Collaborated closely and interacted with fellow Clinical and Commercial team members to develop operating plans for oncology. Supported clinical trials, protocol development, investigator initiated research and strategic publications. Products included: Aromasin® (Exemestane), Celebrex® (Celecoxib) oncology, and figitumumab. Provided oversight for execution and management of MA strategies and dotted line leadership to the Regional Medical Research Specialist team to support product life cycle activities and key messaging. • Ensured integration of the asset strategies for tumor types; accountable for the seamless application of the tumor strategy across all applicable assets assigned to Medical Affairs. • Provided input to Clinical Development colleagues regarding development strategies and clinical trial concepts for investigator-sponsored, company-sponsored and cooperative group trials. • Worked collaboratively with and influenced external partners and KOL on global medical affairs strategies. • Established strong professional rapport with key customer segments to enhance value of Pfizer Oncology unit. • Developed and oversaw brand publication strategies. • Led strategy and administration of external educational grants and continuing medical education support.
Senior Medical Director | Group Leader | Medical Regulatory Services
January 2000 --- January 2007
Promoted to create and lead a group of up to 13 Medical Directors to be active members of high priority product teams across therapeutic areas, providing medical expertise for promotional, labeling, and clinical activities. Responsible for medical reviews of domestic and core international advertising and promotional materials, including product-related sales training materials and field force communications. • Educational resource to medical team members and Pfizer leadership for medical, legal, regulatory, and marketing. • Facilitated responses to medically related product queries and global product labeling issues from regulatory agencies. • Prior to 2004 reorganization, managed the Educational Operations Team, Quality Standards Teams, and Financial Disclosure Team with 50+ staff members.
Director | Medical Services
January 1998 --- January 2000
Recruited to supervise the development and implementation of global product labeling for all P-D pharmaceutical products. Provided support to the strategic development of advertising and promotional materials. • Key medical launch team member for Omnicef® (Cefdinir) and FemHRT® (Norethindrone Acetate, Ethinyl Estradiol). • Provided ongoing medical support for Lipitor® (Atorvastatin) and Rezulin® (Troglitazone) including global medical and regulatory challenges. • Conducted medical review of global advertising and promotional materials as well as other external documents to ensure medical and scientific validity. • Reviewed global competitive promotional challenges and developed market intelligence. • Collaborated with the legal division, providing medical expertise for case litigation. • Medical member of the global Product Review Committee that reviewed and addressed the medical impact of product deficiencies and manufacturing issues.
Medical Director | Medical Services
January 1997 --- January 1998
Selected to transition to the Merck Vaccine Division focused on developmental live virus vaccines. Responsible for creating trademarks and branding for new vaccine products in conjunction with outside marketing consulting firms. • Developed marketing forecasts for new products. • Provided marketing input for technical and stage reviews for new products and presented analysis to senior management in R&D and manufacturing divisions. • Created positioning presentations for new products to increase corporate funding for continued development. • Managed market research/focus groups to assess healthcare professionals' responses to developmental vaccines. • Attended FDA and CDC advisory meetings to present findings and influence policy for US vaccine programs. • Managed 4 vaccine products in the Merck portfolio including Rotavirus (infantile diarrhea), Zoster (shingles) and two other vaccines under development.
Team Leader | Director | Medical Services Hospital Group | Long-Term Care & Infectious Disease
January 1994 --- January 1997
Promoted to managed a team of 11-13 direct reports (Medical Directors, Scientists, Medical Communication Experts) charged with developing educational materials to support Merck’s portfolio of anti-infectives & vaccines as well as the release/re-release of products (VARIVAX, VAQTA, COMVAX). Provided regional educational & information support for anti-infectives & vaccine products as well as medical education on products to extended groups such as medical doctors, RNs, physician assistants, pharmacists & new Healthcare Providers with National Service Center. Provided Merck/Medco Managed Care with medical review of practice guidelines & scripts for consumer education. • Directed Hospital Group, Long-Term Care Group & Infectious Disease Group to shape a common team purpose, agree on performance goals, & define a common working approach. • Created new Oncology Medical Backgrounder to support use of PRIMAXIN for patients with neutropenic sepsis. • Reviewed/approved draft chapters on "Cephalosporins & Related Agents" published in AMA Drug Evaluation. • Collaborated with Marketing on marketing approaches, journal ads & advertising targeted to both medical doctors & consumers to ensure efficiency & accuracy in the development of appropriate promotional materials starting in the earliest stages of creative development. • Worked with Merck’s Legal Division to review & assess product-related litigation & other documents, providing medical opinions & recommendations. • Key member of team that implemented plan to consolidate, centralize & manage medical inquiries for all customers in conjunction with Merck's National Service Center (NSC). • Directed medical student summer internship program. • Analyzed/edited pre-launch & worldwide labeling for Merck's vaccine candidates including chicken pox, hepatitis A, & combination vaccines. Received special commendation for accuracy in labeling review of VARIVAX.
Associate Director | Professional Communications | Merck Human Health Division
January 1992 --- January 1994
Provided medical information, communication, and education for a portfolio of anti-infectives and ophthalmology products (PRIMAXIN, MEFOXIN, NOROXIN, TIMOPTIC and CHIBROXIN). Reviewed and edited Sales, Field Communications and Electronic Information Systems regarding presentation of medical/legal issues and concepts Managed 3 direct reports. Collaborated to train and develop 3 new Associate Directors. • Partnered with Marketing to travel the country and deliver talks to 1,500+ Medco Pharmacy professionals located across the country, to educate/inform on anti-hypertension treatment, medications and therapy. • Developed and delivered Phase I, II and III medical education programs for Regional Business Units and Sales Representatives including updating and revising existing materials. • Point of contact and resource for addressing questions on product labeling. • Responded to Professional Information Requests (PIRs) on vaccines and infectious diseases. • Represented Medical Marketing on Medical/Legal Review Boards. • Provided extensive assistance to Government Affairs Department during strategic drive to place Merck products on many formularies, including the California Medicaid Formulary. • Generated medical bulletins on new drugs such as NAPROXEN. • Initiated a medial student preceptorship within Medical Services with an ongoing rotation of 2 interns invigorating the department with the latest studies in medical schools.
Attending Physician | Department of Internal Medicine
January 1986 --- January 1992
Medical Director | Home Care Medicine
January 1986 --- January 1992
Private Practice | Internal Medicine
January 1986 --- January 1992
Resident | Internal Medicine
January 1983 --- January 1986
Doctor of Medicine (M.D.) in Internal Medicine from UMDNJ-Rutgers Medical School in 2004
Microbiology Major | Early Acceptance into Medical School in from Rutgers College | Rutgers University in 0
Training and Certification
American Board of Internal Medicine Board Certified, 1990 Certification
Licensed in the State of New York Certification
National Board of Medical Examiners Diplomate, 1983 Certification