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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Professional Summary

Proven leader, relationship builder, and strategic thinker excelling in the use of innovative and strategic approaches to achieving business and policy objectives. Exceptional communicator skilled in defining strategic direction, developing forward-thinking strategic plans, and implementing and executing tactical imperatives. A connector, skilled at engaging cross-functional stakeholders on initiatives with global scope, including global regulatory agencies, advocacy organizations, and international trade partners.

Skills
  • Creative and innovative thinking
  • Coalition and team building
  • Advocacy relations
  • Broad scientific and clinical knowledge
  • Stakeholder engagement
  • Expert negotiation
  • Managing people/resources
  • Strategic thinking and tactical execution
Work History
Policy Director, Global Oncology Lead, Regulatory Policy, 04/2019 - Current
Amgen, Inc City, STATE,
  • Lead Amgen's global policy efforts to support the oncology therapeutic area. Influence global policy with a focus on shaping the regulatory environment to enable streamlined development programs.
  • Responsible for development of global strategic plans on large-effect size policy efforts with global scope.
  • Direct internal alignment and external engagements in partnership with Amgen's senior leadership to yield measurable policy outcomes.
  • Interact extensively with industry trade groups (BIO, PhRMA, and IFPMA) and advocacy groups to accomplish policy objectives and engage with various global regulatory agencies (e.g. FDA, HC, EMA, WHO).
  • Lead strategic engagements with global regulators to shape regulatory policy and direct efforts across Amgen to support regional policy objectives.
  • Efficiently manage multi-million dollar budget and provide mentorship to junior staff.
Policy Director, Global Biosimilar Policy Lead, 07/2016 - 03/2019
Amgen, Inc City, STATE,
  • Lead Amgen's global policy efforts in the biologics and biosimilar regulatory space.
  • Directed numerous engagements in partnership with Amgen's senior leadership that resulted in measurable policy outcomes with global reach.
  • Engage extensively with industry trade groups to accomplish policy objectives by working with various global regulatory agencies (FDA, EMA, MHRA, WHO).
  • Lead strategic engagements with global regulators to shape policy in line with business objectives.
  • Support Amgen Government Affairs with expert testimony across the United States in support of state pharmacy legislation.
  • Lead and support various initiatives within Amgen to streamline business processes in line with changing regulatory policy.
Senior Scientist/Principal Scientist, Therapeutic Discovery, 12/2006 - 07/2016
Amgen City, STATE,
  • Played an integral role in the Discovery Research Organization through engaging in identification and optimization of drug candidates.
  • Evaluated technology and initiated key partnerships with academic institutions to partner in research efforts. Managed relationships, project deliverables, and budget
  • Awarded the Amgen Innovation Award in 2015 for work on NMR methods for the characterization of proteins
Education
Ph.D: Analytical Chemistry, Expected in 2004
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University Of Arkansas - Fayetteville, Arkansas
GPA:
B.S: Chemistry, Expected in 1998
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Stephen F. Austin State University - Nacogdoches, Texas
GPA:

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Resume Overview

School Attended

  • University Of Arkansas
  • Stephen F. Austin State University

Job Titles Held:

  • Policy Director, Global Oncology Lead, Regulatory Policy
  • Policy Director, Global Biosimilar Policy Lead
  • Senior Scientist/Principal Scientist, Therapeutic Discovery

Degrees

  • Ph.D
  • B.S

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