Project Manager Director
Resume:
John Waddell, RPh
MANAGING DIRECTOR - TSM Associates
West Chester, PA
**********@*****.***
A well-referenced, health industries commercial consulting leader noted for serving as Commercial Project Director for drug development programs from Phase Two through launch providing commercial POV for trial design and tactical plans. Served as project director for brands including SOHONOS®, LYNPARZA®, BRILINTA® NUVIGIL®, and the heart failure indication for TOPROL-XL® among others. Proven ability to work well with principal investigators, thought leaders, key opinion leaders, as well as internal commercial, medical, and clinical leaders. Counted on to provide competitive intelligence, marketing acumen, market research, and business development insights through launch. Deep experience in drug development and life cycle management. Experience in launch planning, strategy, and tactical implementation. Early adopter of Salesforce.com®, Veeva® and Microsoft™ Sharepoint®. Biopharmaceutical industry professional with strong expertise in building business cases including forecasting, P&L and what-if analyses for branded drug development, in-licensing, and out-licensing transactions. Unique industry experience across a broad set of cross-functional roles. A proven analytical thinker and project manager with a record of developing and implementing complex business intelligence plans and a repeatedly demonstrated ability to lead without authority in highly matrixed organizations by establishing empathy and earning influence with diverse subject matter experts. Broad understanding of the global biopharmaceuticals marketplace and an exceptional ability to contribute meaningfully to both clinical and commercial roles. Skilled at managing agencies and other external partners. Eleven years of staff management experience in sales, marketing and consulting evidenced by a strong network of mentors and mentees. Industry commentary published in Forbes, Pharmaceutical Executive, Med Ad News, Medical Marketing & Media, MichBio Biomatters & HealthCare Distributor, Contract Pharma and Practical Dermatology magazines.
Qualifications and skills include:
In-licensing and Out-licensing transactions, Business Insights, Competitive Intelligence, Forecasting, Building Business Cases including What-If Analyses, Specialty Distribution Sales & Marketing Experience, President's Achievement Award Winner for Sales Excellence (4X) and Specialty Pharmacy Sales
Served as commercial project manager leading brand teams across multiple client organizations in the analysis and release of pivotal trial data and senior executive management approval of NDA/BLA/MAA FDA submission and launch strategies for new chemical entities in all major therapeutic categories and specialty drug markets.
Led the client-side business case for acquisition, clinical developmental program and commercialization plan of a mid-stage entity which eventually achieved $2B plus in annual sales and a market leading position in CNS indications.
Led all business insight processes for pre-Phase 3 business case approvals at multiple manufacturer clients including leading brands in the CNS, CV, rare diseases, and primary care markets, among others.
Highly accomplished in navigating commercial and government access issues across pharmacy and medical benefit designs (medical and pharmacy benefits). Strong understanding of specialty pharmacy and specialty distribution businesses including direct experience managing specialty pharmacy & distributor operations.
Performed as outsource product manager for a blockbuster brand over the last 18 months of exclusivity, establishing new call and sampling plans and cost containment measures informed by a comprehensive competitive intelligence initiative and resulting in an improvement in net contribution exceeding $70MM.
Agency-side and client-side experience in clinical medical communications, advertising and promotional response analytics, experience in brand launch and promotional strategy and creation and execution of promotional and medical communication campaigns.
Career-long achievements in biopharma sales, sales management, brand management and business development winning President's Achievement Award in sales, national accounts, and management roles (4x).
Work Experience
MANAGING DIRECTOR
TSM Associates - West Chester, PA
Founded a sole proprietor consultancy serving over twenty-five pharmaceutical and biotechnology manufacturer clients and drug distributors and PBMs. Solely accountable for business planning, sales attainment and maintaining client relationships and managing a team of independent, 1099-m consultant partners.
Project Examples
Established a predictive tool for forecasting national, regional, and local market share change produced by altering "quality of formulary access" (QofA) of a given brand at individual plans. Model produced a correlation coefficient of 0.86 for regional QofA vs regional NRx share.
Conceived of and built the business case, operational plan and promotion plan for a post-expiry, product loyalty card program to boost patient loyalty and adherence with an oral solid oncology drug achieving superior retention rates when plotted against analog post-expiry brands.
Piloted the repurposing of the Veeva Vault (TM) promotional review system to predict resource requirements at key brand life cycle events by capturing prospective estimated and retrospective actual review requirements, a previously unrecognized capability for Veeva Vault (TM) which aids in product launches and other peak times which strain promotional regulatory review capacities.
GROUP DIRECTOR
CHS Inc - Saratoga Springs, NY
Founded and managed the Philadelphia office for this start-up, outsource-marketing consulting firm achieving $14.4MM in annual sales and developing twenty-two major pharmaceutical manufacturer clients in two years while hiring, leading, and managing a team of twelve consultants.
NATL ACCT DIR, MGD CARE MKTG DIR, BRAND DIRECTOR
Astra Merck Inc - Wayne, PA
Entered to form National Account Director team and advanced to Market Research Manager and Brand Director. President’s Award in national accounts. Featured in Pharmaceutical Executive. ‘Vendor of the Year’ for CVS, Express Scripts and Cardinal Health.
DIRECTOR OF PHARMACEUTICAL SERVICES
Cardinal Health Inc - Dublin, OH
Responsible for all branded pharmaceutical formularies, vendor relations and product promotions in addition to having management responsibilities for a staff of six marketing managers. Won the Healthcare Distribution Management Association's "Innovation for Success" award. Led integration of marketing programs for major acquisitions including Whitmire and Behrens.
PROF PROD REP, MED CTR REP, DIV SALES MGR
Genentech Inc - Nutley, NJ
Began in an entry level sales position and progressed to Medical Center Representative and Division Sales Manager with staff management responsibilities for twelve representatives. Won the Roche "President's Achievement Award" (X2) & "Teamsmanship Award". Represented Roche Laboratories to the Medicaid Formulary Committees for the States of Ohio and Michigan.
Education
• UCLA Anderson School of Management; Medical Marketing, Executive Education
• Northwestern University Kellogg School of Management; Pharmaceutical Marketing, Executive Education
• The Ohio State University; BS in Pharmacy
Licenses & certifications
• Registered Pharmacist
Skills
Market Research, Competitive Intelligence, Business Intelligence, Communications, Advertising & PR
Registered Pharmacist Promotional Regulatory Compliance, Business development; in/outlicensing Market Research Strategy Development, Licensing, Launch Tactical Planning, Messaging, and Promotional Strategy
Honors & awards
HDMA Innovation for Success Award Winner - The Healthcare Distribution Management Association
Roche President's Achievement Award - Roche Laboratories (2x) and AstraMerck President's Achievement Award (2x)
Roche Teamsmanship Award - Roche Laboratories
Registered Pharmacist - OH, PA & DE
Astra Merck Award for Special Achievement - Annual Report - Astra Merck Inc
Leveraging HIT Providers to Improve Adherence with Pharmacotherapy - Pharmaceutical Executive
Vendor of the Year – CVS, Cardinal Health, and Express Scripts
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