Medical Information Director in Philadelphia PA Resume Kiumars Q Vadiei by KiumarsQVadiei

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Kiumars Q Vadiei is a Life Sciences and Medical Information and Communication Professional with experience in Medical Affairs and Clinical Research at large and small pharmaceutical and biotechnology companies; Functioned as a visionary leader and creative manager with sound business acumen in Medical Information and Scientific Communications roles responsible for supporting commercialization of medicinal products (e.g., immunology, oncology, neurology, psychiatry, pain, renal, GI, human genetics); Demonstrated excellent organizational development skills with successful track record in developing & motivating staff, and building cohesive teams to consistently obtain high performance; Created an open environment to promote professionalism, respect, innovation, accountability, and excellence; Proven ability to inspire and influence others, take initiatives, and solve complex organizational and business problems.

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									                                     Kiumars Q. Vadiei, PhD, RPh, FCP
Exton, PA 19341                                                                              Cell: 610.659.3430
kvadiei@biopharmaffairs.com                                                                 Home: 484.875.0594
http://www.linkedin.com/in/kiumarsqvadiei

                                                  EXECUTIVE PROFILE

Life Sciences and Medical Information and Communication Professional with experience in Medical Affairs and Clinical
Research at large and small pharmaceutical and biotechnology companies; Functioned as a visionary leader and creative
manager with sound business acumen in Medical Information and Scientific Communications roles responsible for
supporting commercialization of medicinal products (e.g., immunology, oncology, neurology, psychiatry, pain, renal, GI,
human genetics); Demonstrated excellent organizational development skills with successful track record in developing &
motivating staff, and building cohesive teams to consistently obtain high performance; Created an open environment to
promote professionalism, respect, innovation, accountability, and excellence; Proven ability to inspire and influence
others, take initiatives, and solve complex organizational and business problems.

                         CORE COMPETECIES & RESPONSIBILITIES in MEDICAL AFFAIRS

Organizational Responsibilities:
    Created dynamic and matrix organizational structures to address the therapeutic area needs and provide cross
       functional support (e.g., call center, operational systems, procedures, and education resources).
    Collaborated with commercial, legal, compliance, regulatory, clinical, drug safety, and quality assurance.
    Developed integrated strategic and tactical plans for optimal execution of key functional objectives consistent
       with departmental and corporate goals; Oversaw annual program budget of up to $ 3,000,000.
    Provided operational leadership in US and multiple affiliates in Europe, Asia, and rest of the world (ROW).
    Served as a key medical and scientific resource within Medical Affairs and across the organization.
    Recruited and managed highly qualified professionals, developed job descriptions, created assessment tools, and
       training program to enhance staff competency, increase efficiency, and boost leadership development.
    Established good working knowledge of regulatory and government requirements (e.g., FDA, OIG).
    Authored multiple SOPs, work instructions, and manuals to ensure functional and operational consistency,
       efficiency, and transparency; served on a corporate audit and review team.

Strategic and Operational Responsibilities:
     Guided and oversaw development of key medical information (MI) documents including written standard
         response documents, verbal FAQs, medical slides, monthly literature reviews, and educational brochures.
     Managed professional call center; directed proper capture, documentation, and processing of MI inquiries, initial
         reports of adverse events (AEs), special safety events (abuse, diversion), and product complaints.
     Developed and managed a team of medical science liaison (MSLs), developed MSL scientific and clinical plan for
         effective educational activities, managed care support, and key opinion leader (KOL) engagement.
     Developed publication strategy; drafted, reviewed, and approved abstracts and publications; guided publication
         logistics including author selection, contractor support, and journal submission.
     Served as a member of corporate education board to provide scientific oversight and strategic vision for medical
         affairs advisory board meetings, investigator meeting, and medical education and symposia.
     Organized and staffed MI booths at scientific meetings and medical congresses; gathered and reviewed
         competitive intelligence to support medical and commercial activities.
     Developed RMP, safety assessment tolls, and medication use brochures in collaboration with drug safety.
     Created periodic reports for call center activities, medical meetings, and relevant operational activities.
     Guided concept discussions, reviewed content, negotiated context, and approved promotional materials.
     Developed and implemented market support activities (e.g., drug access, patient assistance program,
         compassionate use and access program); engaged in disease and patient advocacy campaigns.
     Guided development of AMCP Dossier, drug utilization review summary, and managed care presentations;
         Interfaced with medical team, health economics group, field-based MSLs, and managed care organizations.
     Screened, reviewed, and updated drug compendia and external medical information review documents.
     Participated in training activities (i.e., material development, review, and presentation) for sales staff, speakers,
         medical science liaisons, and other internal stakeholders.
     Reviewed phase IIIB/IV clinical trials protocols; developed strategy, tactical plan, and program policies for
         investigator-initiated trials (IITs), provided operational leadership for implementation of IIT program.
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                                            PROFESSIONAL EXPERIENCE

BioPharmAffairs Consulting, Exton, PA                                              2010 – Present
Principal Consultant, Sr. Director Medical Information and Communication
Consult with pharmaceutical, biotechnology, and device companies in medical information, scientific communication,
organizational and operational s excellence, communication with healthcare professional, field-based medical activities,
commercial and promotional endeavors, market assessment, managed care, medical education, publication strategy and
medical writing. Design phase I-IV clinical studies, conduct data analysis, and prepare study reports.
Selected Achievements:
      Develop a phase I (formulation/PK) and a phase II (proof of concept) clinical study protocols.
      Develop, conduct, and analyze a managed market assessment survey.
      Prepare medical feasibility and clinical practice utility white paper.
      Prepare healthcare professional communication and awareness letters.

Shire Pharmaceuticals, Wayne, PA                                                   2007 – 2010
Sr. Director, Global Medical Information and Communication
Led Medical Communications Department in support of global CNS, GI and Hematological products, and US Renal &
Human Genetics Therapy products. Provided operational leadership for Europe, Asia, and Pacific Rim affiliates.
Managed 5 direct reports and 7 medical communications professionals.
Selected Achievements:
      Drove the medical launch of several new (Vyvanse, Intuniv, Daytrana, Lialda, Fosrenol) products in the US and
         ROW successfully and promptly.
      Designed and implemented a comprehensive promotional review management process resulting in 20% to 50%
         cost-saving, reduced review and approval time (> 1-2 weeks), increased processing efficiency, and significantly
         greater compliance with regulatory submission requirements compared to historic values.
      Developed close partnership with corporate managed care and alignment with health economics group to
         significantly improve formulary coverage and product reimbursement (100% formulary acceptance / 75%
         preferred status).
      Established communication among US and international affiliates to confirm awareness and consistency of
         relevant medical information, best practices, and operational support activities (35% reduction in redundancy).
      Implemented timely transition and integration of all medical communications activities of an acquired ADHD
         product (Equasym) for European market resulting in uninterrupted market access and medical acceptance.
      Received several company-sponsored awards for collaboration and result-oriented projects.

Cephalon, Frazer, PA                                                              1998 – 2007
Sr. Director | Director, Medical Information and Communication
Established Medical Communications department to ensure proper communication of medical information of company’s
marketed products in US (CNS, neurology, and oncology). Served as medical communications advisor to European and
Pacific Rim affiliates. Managed 6 direct reports and 15 medical communication professionals.
Selected Achievements:
      Developed a comprehensive organizational structure, functional guidelines, strategic plan, and operational tactics
         to optimize functioning consistent with corporate needs and growth.
      Established and managed the first MSL team for over 3 years supporting the sleep and pain franchise; engaged in
         sleep science awareness campaign and direct engagement with KOLs resulting in wide acceptance for new science
         in wake-promotion.
      Created a wide-ranging call center to support medical communications, product safety, product quality, and
         clinical research resulting in >98% customer satisfaction.
      Developed a comprehensive electronic knowledgebase for easy access to medical communication documents,
         research publications, and periodic medical updates providing 100% corporate wide access and elimination of
         redundancy.
      Led successful and prompt medical launch of several products in the US market (e.g., Provigil, Nuvigil, Actiq,
         [Anesta], OTFC, Fentora, Vivitrol [Alkermes]).
      Received multiple awards for successful transition and integration of medical communications activities for
         acquired products (Gabitril [Abbott]; Trisenox [CTI], Treanda [Salmedix]) and professional call center
      Collaborated with marketing teams and led development of highly scientific, quality-driven, audience-friendly,
         and cost-effective promotional materials.


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Pfizer (formerly Wyeth Pharmaceuticals), Collegeville, PA                        1991 – 1998
Sr. Manager, Medical Information and Communication
Managed medical communication activities – Acute/chronic pain, arthritis, obesity, neurology, psychiatry.
Selected Achievements:
      Managed the medical information call center during market withdrawal of Redux
      Led the medical launch of Duract and subsequent withdrawal from market
      Led the medical launch of Synvisc (medical device for osteoarthritis)
Sr. Clinical Pharmacokineticist
Designed, conducted data analysis, and prepared study reports for phase I & II clinical pharmacology and
pharmacokinetics studies for investigational products in immunology, cardiovascular, and infectious diseases.

                              ACADEMIC EXPERIENCE, FELLOWSHIP, MENTORSHIP

Mentorship, Temple University Fox School of Business and Management - Be Your Own Boss Bowl (2011)
Pharmacy Preceptor Industry Rotation, Temple University and Philadelphia College of Pharmacy (1999 – 2007)
Adjunct Professor, Temple University, Philadelphia, PA (1999-2003)
Research Scientist, The University of Texas, M.D. Anderson Cancer Center, Houston, TX (1991)
Teaching Instructor, University of Houston, Houston, TX (1988-1991)
Pre-Doctoral Fellowship, The University of Texas M.D. Anderson Cancer Center, Houston, TX (1988-1990)

                                        PHARMACY PRACTICE EXPERIENCE

Staff Pharmacist                                                          1984 - Present
Retail Pharmacy - Eckerd Drugs, Rite Aid Pharmacy
Long-Term Care & Hospital Pharmacy - Synergy Pharmacy Services, Triumph Hospital Philadelphia

                                                     EDUCATION

PhD, Pharmaceutical Sciences and Pharmacokinetics, University of Houston, Houston, TX (1991)
Bachelor of Science, Pharmacy, The University of Texas at Austin, Austin, TX (1984)

                                                 TRAINING COURSES

Population Pharmacokinetics, SAS Training, Corporate Leadership and Business Acumen, Pharmaceutical Regulatory
Affairs and Industry Regulations, Oncology Disease Management

                                                 COMPUTER SKILLS

Microsoft Office Suite (Word, Excel, PowerPoint, Publisher), Information Request Management System ([IRMS], Medical
information processing), ZincMaps (Promotional review processing), Medical slide management system (Exploria), SAS
(Statistical analysis), WinNonlin (Pharmacokinetic data analysis)

                                    PROFESSIONAL LICENSES & AFFILIATIONS

Pennsylvania Pharmacy License No: RP-039247 (Active 2012)
Texas Pharmacy License No: 28230 (Active 2012)
Fellow, American College of Clinical Pharmacology (FCP)
Member, Drug Information Association (DIA)
Greater Philadelphia Senior Executive Group (GPSEG)

                                         PUBLICATIONS & PRESENTATIONS

Presented on liposome technology, sleep medicine, renal failure, pharmacokinetics, and drug information activities.
Published 30 articles in peer-reviewed journals and presented 28 posters regarding oncology, immunology, pain, sleep
medicine, acute renal failure; other topics included managed care and drug information activities.




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