Sandie Anderson

Sandie Anderson

Work History

Work History
Oct 2007 - Present

Director, Program Management

Alexza Pharmaceuticals

Recruited to lead drug-device supplier in company-first NDAs; formulated systems and processes, governance procedures, roles and responsibilities, and tools for program management for drug-device combinations.Headed 15 physicians, scientists, and engineers in developing 2 novel Staccato® inhalation drug delivery products reaching phase II from pre-clinical/phase I status; contributed to 1 project reaching phase III.

Jun 2005 - Sep 2007

Program Director and Compund Development Team Leader

Johnson and Johnson Company

Directed 22-member team and $5M+ budget for next generation IONSYS transdermal drug-delivery device system for acute pain management, handling resource management, decision analysis, and metrics benchmarking. 

Architected data-driven process and decision-making matrix to assess technology for possible inclusion in Phase II trials; uncovered key risk factors leading to “no go” decision.

Feb 1993 - Jun 2005

Section Head

Procter and Gamble Pharmaceuticals

Defined features for first and second generation testosterone patch, including size, texture, shape, color, and comfort to meet consumer expectations within highly sensitive product category.

Modeled product lifecycle management, creating matrix to assess present state, goals, and competitive landscape to enable proactive strategies; approach was adopted as best practice by other product teams.

Leveraged genomics to understand underlying mechanisms of hair loss, linking pyrithione zinc to hair growth with same efficacy as 5% minoxidil; devised and executed business case and marketing approach.

Utilized breakthrough DNA techniques to distinguish the six species of Malassezia found on the human scalp, unraveling the root cause of dandruff and leading to more effective treatments.

Completed IND submissions for cardiac drug oral tablet and IV product; directed polymer research on controlled release systems, coatings, adhesion, and packaging.

Education

Education
Sep 1989 - Jun 1993

PhD

Thesis: A Model of Antiplasticization Mechanisms in Polystyrene

Sep 1980 - Jun 1986

BS (Honors), MS

Thesis: Flocculation of Clay and Coal Suspensions Using Synthetic Polymers

Objective

Results-oriented, I am consistently recognized for my ability to envision possibilities, and my passion as a connector. 

Summary

Results-oriented, I am consistently recognized for my ability to envision possibilities, and my passion as a connector. I will add value to your company's bottom-line through my extensive Product Development & Launch, Clinical Research, Risk Assessment & Mitigation, and Alliance Management experience, described below:

Management Executive and proven innovator shaping consumers' interactions with products through expert leadership of development programs.  Leverages background in regulated environments to establish highly efficient systems, processes, and tools; led multiple regulatory submissions and launches in Asia, Europe, and North America. 

�Created global product development vision, strategy, and operational plans to position Fortune 50 company as leader in women's health via unique post-menopausal treatment. Captured $200M+ in Europe and prepared FDA submission. 

�Led team that identified hair-loss prevention benefits of Head & Shoulders and formulated credentialing and outreach strategy to leverage discovery to drive incremental revenues beyond $1B.

�Incorporated "voice of the consumer" into features profile for post-surgical pain product; completed cross-cultural research in pain response in Asia, Europe, and North America within 2 months. 

Program Leader architecting processes to expedite product development cycles and increase quality.

Proved instrumental to creation of infrastructure for company's first new drug application (NDA); produced interactive online roadmap and training courses for 150+ team members/partners aligned with FDA regulations.

Concluded quality-system procedures assessments for pre-approval inspection preparations within 6 months vs. 12-month schedule; coordinated 100 personnel in SOP definition, gap analysis, process revisions, and training.

Finalized development and chemistry manufacturing controls (CMCs) for first-generation NDA 3 months ahead of schedule and propelled second generation to clinical research stage 1 year ahead of schedule. 

Collaborative Leader forging productive external partnerships to expand capabilities and speed time-to-market.

Overcame product-development roadblock by bringing together patent owner, technology provider, and lead marketing company; achieved buy-in from all parties and set contract milestones and metrics.

Saved 10%+ and completed product engineering 3 months faster than forecast by pairing complementary design and engineering firms to create parallel process for consumer research and design.

Accelerated projects up to 50% through outsourcing of non-core functions, thereby supplying turnkey solution to hasten response to competitive threats. 

Interest

My ideal job responsibilities include: (1) collaborating across business functions and with external companies/institutions to creatively integrate opportunities for unmet patient and consumer needs in the marketplace; (2) developing and implementing global technology and product development vision, strategies, and plans; (3) growing and maintaining an environment for effective use of resources, and (4) coaching and developing others.