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.

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.
• 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.
• 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.
• 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.
• 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.

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.

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.
• 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.
• 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+.
• 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.
• 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.
• 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).

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.
• 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)