Michael Stankiewicz Email & Phone Number

BeiGene (Emeryville, CA) – Program manager on early clinical and pre-IND projects for anoncology company. Responsible for cross-functional leadership of global development teams. Led first research-to-development project under the new BeiGene global development organizational structure.NGM Biopharmaceuticals (South San Francisco, CA) – Program manager and ophthalmology advisor for a clinical stage company starting its first ophthalmology program. Responsible for cross-functional leadership of internal leads, creating a development plan, and forming a team of external advisors (key opinion leaders and consultants).Graybug Vision (Redwood City, CA) – Program manager overseeing IND-enabling activities and early development screening activities for a startup focused on novel ocular drug delivery. Responsible for cross-functional project leadership of a virtual team, including consultants and contract vendors. Graybug Vision develops products to reduce the frequency of dosing for ocular therapies using its controlled release technology.Annexon Biosciences (South San Francisco, CA) - Project management lead overseeing IND-enabling activities for two compounds at a startup focused on neurodegenerative disorders. Responsible for cross-functional program leadership for a virtual team, including internal experts, consultants, and contract vendors. Annexon's antibody pipeline includes therapeutic products that halt the progression of complement-mediated neurodegeneration (CMND).

Bridgewater, Nj, Us

Project leader and project management director for new ophthalmology products. Coordinated cross-functional strategic leadership teams, communicated with R&D management, created and monitored project plans, and led teams in proactive identification of opportunities and risks.• Nutritional development team – Led a virtual cross-functional team (including external CMO) to launch the company’s first multivitamin (Ocuvite Eye+Multi); led negotiations between commercial and product development to enable a launch five months earlier than planned; and facilitated a lessons learned process to increase efficiency for future nutritional project teams.• Glaucoma development team – Primary liaison for alliance management with European-based partner; led a cross-functional project team to successfully conclude a slow-enrolling Phase 2b study with four months remaining before drug product expiry; coordinated internal decision to initiate a Phase 3 program in the US, Japan, and Europe, which triggered a milestone payment.• Retina alliance partnership – Project manager for the company’s lead retina project, an alliance partnership with a startup company for its device technology to treat retinal vein occlusions; led the successful IDE filing with the FDA in four months for approval to start a proof-of-concept study; and drove project closeout activities with business development and legal after B+L returned the project’s rights to its partner. • Dry eye development team – Led the transfer of a formulation from a US to EU-based development team for a next-generation over-the-counter dry eye product; led team discussions to terminate the initial formulation based upon its probability of success/risk profile and recommend a new formulation targeted to meet the target product profile attributes.

Selected agenda topics and identified speakers for “How to Make your Project Successful in Emerging Markets” for BioPharma PM’s annual meeting. Speaker liaison responsible for presentation topic identification, guidelines, and editing. BioPharma PM provides the opportunity for learning, growth and networking to project managers in the pharmaceutical, biotech, medical device and CRO industries.

New York, New York, Us

Led core drug project team’s drug development strategies and aligned clinical, regulatory, safety, operations, and manufacturing teams with those strategies. Communicated project status and risk management plan to team and its internal and external stakeholders.• Retina development team – Led the transfer of a drug product from an alliance partner; drove the successful initiation of clinical development in a second indication; coordinated development plans, including market assessment, clinical, regulatory, and manufacturing strategies, and risk management plans; and led a cross-disciplinary team’s initiation of Phase 2 proof of concept trials in 10+ countries.• Pediatric development team (product enhancement for an approved product) – Led the submission of Pfizer’s first successful Paediatric Investigation Plan (PIP) with the EMEA and initiation of a Phase 3 trial in 30+ countries.• Retina preclinical team – Managed the pre-IND assessment of pharmacology and toxicology for multiple drug candidates and led team discussion and governance communication of recommendation to terminate compounds based upon an unfavorable risk-benefit profile.• Ophthalmology drug delivery team – Integrated drug delivery strategy into development plans by leading a virtual team that researched how drug delivery technology can increase the value of the portfolio and established relationships with external partners with innovative technologies.• Oncology NDA submission safety narrative team – Led a global team (including CRO) for quarterly safety update narratives as part of successful NDA and sNDA submissions (Sutent). • Created a cross-cultural training seminar for ophthalmology staff as part of a successful new partnership to plan parallel submissions in both Japan and the United States for all projects in the portfolio.

New York, New York, Us

Integrated project planning and performance metrics into daily operations of clinical project teams at one of Pfizer's major R&D sites. Ensured alignment with company-wide vision. Sole point-of-contact for metrics activities and information requests from site leadership and project managers.• Led a project office responsible for 70-100 ongoing or planned clinical trial project plans and established a quality control system to ensure accuracy of critical data.• Integrated a performance management culture into clinical project teams via goals, data analysis, and automated data collection and reports, which led to shorter clinical trial cycle time durations.

New York, New York, Us

Technical lead that integrated project planning tools, resource data, and metrics (cost, quality, time, volume) into clinical project team decision-making and reporting.• Developed, implemented, and reported Pfizer Development Operations' first global resource forecasts (3000+ FTEs) by leading a global team of six people based at all of Pfizer's major R&D sites.

La Jolla, Ca, Us

Project Manager that developed research agendas, organized meetings with government and academic collaborators, and published research results for Asia-related diplomatic and trade projects. Managed a series of dialogues among 15-20 diplomats/academics.

Analyzed the marketing strategy of a small Japanese chemical firm that supplies chemical products to U.S. pharmaceutical companies, including a case study to establish a subsidiary production facility in the U.S. Analyzed clients' competitive position in marketplace for safer drug delivery technologies.

Mpia, International Business, Japan

Ba, International Affairs (Related Fields Of Sociology And Economics)