Michael Gerstle

Michael Gerstle Email and Phone Number

TA Group Lead - Vaccines and Clinical Pharmacology, BVSM, CD and O @ Pfizer
Philadelphia, PA, US
Michael Gerstle's Location
Philadelphia, Pennsylvania, United States, United States
Michael Gerstle's Contact Details
About Michael Gerstle

As a seasoned professional in clinical operations, outsourcing, and life science development and technology, I bring a wealth of experience and a proven track record of success to every endeavor. Throughout my career, I've led high-performing teams and managed complex projects, consistently delivering tangible outcomes for clients within the biotech sector. My expertise spans all facets of clinical operations, from ensuring efficiency, quality, and compliance to driving operational excellence through innovative approaches and tailored solutions. I excel in cultivating relationships with key stakeholders and optimizing operational processes to enhance productivity and efficacy in clinical research settings. Committed to delivering superior clinical outcomes while maximizing operational effectiveness, I'm dedicated to driving success and making a meaningful impact in the field of life sciences.Let's connect to leverage my expertise and drive mutual success in clinical operations, outsourcing, and life science development.

Michael Gerstle's Current Company Details
Pfizer

Pfizer

View
TA Group Lead - Vaccines and Clinical Pharmacology, BVSM, CD and O
Philadelphia, PA, US
Website:
pfizer.com
Employees:
100690
Michael Gerstle Work Experience Details
  • Pfizer
    Ta Group Lead - Vaccines And Clinical Pharmacology, Bvsm, Cd And O
    Pfizer
    Philadelphia, Pa, Us
  • Pfizer
    Director, Vendor Strategy Management - Oncology Division
    Pfizer Dec 2023 - Present
    New York, New York, Us
    In spearheading our Oncology Division's strategic vendor partnerships, I am leading strategic category planning, evaluation, and oversight to ensure alignment with our clinical and operational objectives. Collaborating closely with internal stakeholders, we optimize our partnership relationships, streamline processes, and bolster operational efficiencies within our clinical development initiatives. I am driven by a commitment to advancing Pfizer Oncology's goals while maintaining fiscal responsibility. Some achievements:• Integration initiatives for Pfizer's acquisition of Seagen, navigating cross-functional teams through the transition process.• Directed efforts to integrate Seagen into Pfizer's operations, ensuring alignment with corporate objectives and timelines.• Employed operational plans to maximize value from acquisition, driving effectiveness across merged entities.
  • Seagen
    Director, Vendor Strategy Management - Clinical Operations Systems And Services
    Seagen Dec 2019 - Dec 2023
    Bothell, Washington, Us
    As a founding member of Seagen's clinical vendor management efforts, I developed every facet of my categories' efforts, from resource allocation to technology assessment, KPI formulation, and governance activities, ensuring they harmonized with Clinical Development objectives. I took charge of communication, liaising between executive leadership, internal stakeholders, and external vendors. Optimizing contracts was a key responsibility, ensuring value and alignment with business requirements. Some accomplishments within this role are:• Established Clinical Operations Systems and Services categories, encompassing technology systems, data providers, and study and participant support services, aligning closely with Oncology Research & Development (R&D) objectives.• Formulated and executed strategic plans to enhance categories and vendor relationships, driving progress toward Development goals while enhancing a diverse clinical trial portfolio of over 40 studies.• Spearheaded vendor initiatives and strategies that yielded significant cost and time savings, resulting in measurable outcomes, such as 32% cost avoidance in 2023, while also fostering a collaborative environment conducive to innovation.
  • Ha-Moto Consulting
    Managing Director / Consultant
    Ha-Moto Consulting Jun 2007 - Aug 2016
    Seattle, Washington, Us
    My work has been defined by crafting innovative solution strategies and orchestrating their execution. I deliver tangible results across diverse domains for my clients. From the inception of my consultingbusiness, I've showcased entrepreneurial acumen and Life Science industry expertise, attracting and retaining clients through personalized service and unmatched dedication. Below are some of my achievements in this role:• Orchestrated and supervised client personnel, contractors, and cross-functional implementation teams exceeding 20 individuals, ensuring seamless collaboration and optimal technology project outcomes.• Provided operational excellence consulting services for a biotech clinical operations group, leading to substantial organizational enhancements and operational restructuring initiatives.• Provided strategic management of 70-study, $250 million annual spend, CRO relationship for a large biotech company.• Design and implementation of a medical image repository for a large biotech entity.
  • Dendreon Corporation
    Senior Project Manager
    Dendreon Corporation 2006 - 2007
    Seal Beach , Ca, Us
    Responsible for management of corporate projects, supporting drug development and commercialization processes.
  • Cell Therapeutics, Inc.
    Manager, Drug Development Systems
    Cell Therapeutics, Inc. 2001 - 2006
    Seattle, Wa, Us
  • Phase Forward Corporation (Formerly Clinsoft Corporation / Domain Pharma)
    Technical Consultant
    Phase Forward Corporation (Formerly Clinsoft Corporation / Domain Pharma) 1999 - 2001
  • Chiron Corporation (Modis Consulting)
    Clinical Data Management Consultant
    Chiron Corporation (Modis Consulting) 1998 - 1999
    Emeryville, California, Us
    Provided clinical data management and database support for phase I, II and III clinical studies
  • Berlex Biosciences
    Data Management Team Lead
    Berlex Biosciences 1997 - 1998
    Us
    Responsible for day-to-day operations of Data Management Team for multiple Therapeutic Areas.
  • Baystate Medical Center
    Research Coordinator
    Baystate Medical Center 1993 - 1997
    Us

Michael Gerstle Skills

Pharmaceutical Industry Biotechnology Clinical Development Gcp Clinical Data Management Project Management Management Cross Functional Team Leadership Drug Development Fda Regulatory Submissions Strategy Life Sciences Computer System Validation Consulting Document Management 21 Cfr Part 11 Business Process Improvement Clinical Research Cro Data Analysis Oncology Leadership Program Management Executive Management Commercialization Technology Transfer Entrepreneurship Medical Devices Lifesciences Regulatory Affairs Clinical Trials Process Management Manufacturing Systems Ctms Data Management Sop Social Media Marketing Executive Coaching Validation Edc Protocol Quality Assurance Gxp Integration R&d Process Improvement Biopharmaceuticals Pharmaceutics Legal Research Interpersonal Communication Scenario Planning Law Corporate Law Thought Leadership Project Leadership

Michael Gerstle Education Details

  • Seattle University School Of Law
    Seattle University School Of Law
    Cum Laude
  • University Of Massachusetts Amherst
    University Of Massachusetts Amherst
    Biochemistry
  • Franklin & Marshall College
    Franklin & Marshall College
    Economics

Frequently Asked Questions about Michael Gerstle

What company does Michael Gerstle work for?

Michael Gerstle works for Pfizer

What is Michael Gerstle's role at the current company?

Michael Gerstle's current role is TA Group Lead - Vaccines and Clinical Pharmacology, BVSM, CD and O.

What is Michael Gerstle's email address?

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What schools did Michael Gerstle attend?

Michael Gerstle attended Seattle University School Of Law, University Of Massachusetts Amherst, Franklin & Marshall College.

What are some of Michael Gerstle's interests?

Michael Gerstle has interest in Mobile, Social Commerce, Health Care, Science And Technology, Sports, Consumer Internet, Enterprise Software, Entertainment Industry.

What skills is Michael Gerstle known for?

Michael Gerstle has skills like Pharmaceutical Industry, Biotechnology, Clinical Development, Gcp, Clinical Data Management, Project Management, Management, Cross Functional Team Leadership, Drug Development, Fda, Regulatory Submissions, Strategy.

Who are Michael Gerstle's colleagues?

Michael Gerstle's colleagues are Joe Cully, David Siles Marchante, Malleswararao Nandigam, Chakradhar Chekka, Matt Courtney, Rahayu S.kom, Joana Candeias.

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