Pharmaceutical/Biotechnology Project Management Consultant, Integrated Project Management Company
San Francisco Bay Area
Pharmaceutical/Biotechnology Project Management Consultant, Integrated Project Management Company
San Francisco Bay Area
I manage strategic projects for biotechnology and pharmaceutical companies that lack the requisite internal expertise and resources.
My broad scientific background is in the fields of medicine, biochemistry, protein chemistry, molecular biology, genetics and genomics. This is combined with extensive project leader and management expertise and experience.
research areas: medicine, biochemistry, protein chemistry, molecular biology, genetics, genomics, oncology, signal transduction, developmental biology, immunology, pharmacology
Management experience: laboratory management, project management, project leadership, business process optimization, product development and lifecycle management
Specialized training: GLP, GMP, GCP, FDA and ICH regulations, eCTD submission requirements.
(Privately Held; Management Consulting industry)
November 2007 — Present (2 years 1 month)
Project Manager specializing in the life science industry. IPM is focused on helping companies by bringing industry best practices and discipline to manage their critical projects. For more information, visit the IPM website at http://www.ipmcinc.com/.
Created document management processes for a large pharmaceutical company for corporate policies surrounding document authoring and electronic submission of New Drug Applications (NDAs) and marketing authorization applications (MAAs) to the FDA and EU regulatory bodies, respectively, using the electronic Common Technical Document (eCTD) format.
Provided project management expertise for a small pharmaceutical company involved with international partnership to develop new medicines for neglected tropical diseases (NTD). Co-authored National Institute of Health (NIH) grant application to gain additional funding for the company’s NTD program. Created and managed project budgets and plans including alliance, communication, risk, and stakeholder management.
(Privately Held; 51-200 employees; Biotechnology industry)
September 2006 — November 2007 (1 year 3 months)
• Managed large genome-wide association studies to identify genetic loci linked to common human diseases and responses to medication.
• Supervised high-throughput single nucleotide polymorphism (SNP) genotyping projects using high-density oligonucleotide arrays.
• Managed Genetic Association Information Network (GAIN) studies of Attention Deficit Hyperactivity Disorder and Psoriasis for a public/private consortium for the National Institute of Health.
• Enhanced lab workflows, SOPs, LIMS, and data analysis tools.
• Reduced safety violations and improved lab safety practices as Chemical Safety Officer and member of Biosafety Committee.
(Educational Institution; 10,001 or more employees; Research industry)
September 1997 — September 2006 (9 years 1 month)
• Supervised and managed a research group of 52 undergrads and 5 technicians
• Pioneered amphibian genetics and genomics research (http://tropicalis.berkeley.edu/home/).
• Coordinated 28 projects and collaborations while managing costs, resources and personnel.
• Collaborated with the Department of Energy on a Scientific Advisory Steering Committee and held positions on the Xenopus Genome Annotation Committee and Xenopus Microarray Advisory Group.
• Published 9 manuscripts in prestigious scientific journals.
• Presented numerous invited lectures at universities and national meetings/conferences.
• Research has been highlighted and acclaimed in scientific reviews and the press.
• Project has won 19 fellowship and scholarship awards.
Professional Certification , Clinical Research Conduct and Management , 2007 — 2009
Broad training of clinical trial design and management, including FDA regulations, ICH GCP guidelines, practical procedural recommendations, and ethics.
PhD , Biochemistry , 1991 — 1997
• Identified novel connections between major signaling pathways (PI3K, S6K1, and RAS/MAPK) involved in cell proliferation that are closely linked to human diseases including cancer and diabetes.
• Published 10 manuscripts and 2 book chapters.
M.S. , Medicine , 1991 — 1993
B.S. , Biochemistry , 1987 — 1991
Worked on the development of a purification system for the biochemical analysis of a bacterial enzyme, pyruvate kinase.
clinical research, project management, science, technology, investing, stock trading, economics, finance, sales and marketing, blogging
Project Management Lessons Learned yahoo group, Life Network
Project Management Professional (PMP) Certification, Project Management Institute
Leukemia and Lymphoma Society of America Scholar 1998-2001