Anna Pawlicka
San Diego,CA
Summary
Passionate program manager with over 15 years of experience in the pharmaceutical and healthcare industries, known for fostering strong partnerships across functions and influencing effectively without formal authority. Demonstrated proficiency lies in crafting strategic options and harmonizing diverse stakeholder interests. Skilled at leading cross-functional teams, proactively identifying and mitigating potential pitfalls, and driving project execution. Adept at navigating the complexities of drug development planning, leveraging insights to identify acceleration opportunities to optimize program value. Eager to contribute strategic insights and elevate project management capabilities within the pharmaceutical industry.
Overview
18
18
years of professional experience
Work History
Assoc Dir, Global Program Management (Promoted)
Amgen
06.2020 - Current
- Drove the creation and implementation of high-quality, global integrated project plans for early and late-stage programs in the General Medicine TA (obesity and cardiometabolic indications)
- Assessed critical path, conducted risk analysis, and gathered key inputs in support of program progression decisions
- Contributed to the development and execution of the global product strategy by driving business case and scenario planning
- Led cross-functional financial, resource and capacity assessments to inform program decisions
- Managed commercial insights, product delivery and evidence generation work package teams
- Led cross-functional workshops for a late-stage priority program to accelerate projected launch by >6mos
- Partnered with XFN lead to develop and fund the first integrated human data strategy in General Medicine TA
- Special Project: Developed integrated project planning guidance to facilitate onboarding of new hires, improve the use of portfolio management software solution, enhance consistency in reporting key program milestones to executive leadership. Recipient of 'Spotlight Diamond Award' for contributions to this project
Sr. Global Project Manager (Promoted)
Sanofi Genzyme
02.2018 - 06.2020
- Led diagnostic programs for rare diseases, including IVD development
- Projects included partnering with IVD manufacturers and clinical laboratories to support marketed and late-stage therapies, and implementing strategies to support close out of immunogenicity-related post-marketing commitments and planning diagnostic needs for upcoming registrational studies
- EVP award for contribution to remediation of a critical supply issue
- Led the externalization of the internal CLIA laboratory in 1,700 HCPs across 50 countries
- Developed and delivered training to colleagues to increase awareness of IVD, medical device, CLIA regulations, and best practices for laboratory contracting
U.S. Regulatory Manager
Oxford Immunotec
09.2016 - 02.2018
- Advised on regulatory frameworks applicable to U.S. IVD products and laboratory testing services. Promotional Review Committee member responsible for ensuring claim substantiation and consistency with label and regulatory compliance. Regulatory resource for Product Development, Clinical Development with respect to clinical study protocols, Medical Affairs with respect to Investigator Sponsored Research (ISR)
- Advised on regulatory frameworks for U.S. IVD products and laboratory testing services.
- Developed and implemented comprehensive method development procedures for introduction of new clinical testing methods in CLIA-certified, NYS-licensed laboratories
- Special Project: Developed a promotional material procedure and improved operational efficiency by implementing an online review
Global Education & Professional Relations Manager
Oxford Immunotec
07.2014 - 09.2016
- Established and led an international-level Medical Education program
- Represented Global Medical Affairs on the Promotional Review Committee
- Built programs and procedures for a newly formed Medical Affairs function from the ground up
- Drafted procedures for the newly launched Independent Medical Education (IME) program
- Led publication projects, including collaborative research of real-world data
- Mandalakas AM, Highsmith HY, Harris NM, Pawlicka A, Kirchner HL. T-SPOT.TB Performance in Routine Pediatric Practice in a Low TB Burden Setting Pediatr Infect Dis J November 2017
Application Specialist
Leica Biosystems
05.2012 - 05.2014
- Served as primary technical expert for assigned molecular diagnostics products
- Supported launch of a new product through white paper development and early adopter product demonstrations
- Transferred knowledge to global applications and field service colleagues through design and delivery of training programs
- Delivered training and product demonstrations to pharmaceutical, CRO, and clinical laboratory customers
Lead Molecular Technologist
STRATADX
12.2011 - 07.2012
- Validated clinical LDTs for the assessment of progression and relapse of prostate cancer
- Trained pathologists on the use of imaging software to enable remote analysis and reduce turnaround time
Genetics Medical Technologist II
Women And Infants Hospital
04.2007 - 12.2011
- Conducted molecular and cytogenetic analyses (FISH, PCR, karyotyping, southern blots) on patient samples
- Served as the primary technical troubleshooter for molecular diagnostics testing menu
- Trained new technologists and medical residents on molecular and cytogenetic techniques
Education
MBA -
University of Rhode Island
2012
Bachelor of Science - Clinical Laboratory Science
University of Rhode Island
2006
Certification - Medical Laboratory Scientist
American Society of Clinical Pathology
2006
Skills
- Program & Project Management
- Strategic Planning
- Stakeholder Management
- Risk Management
- Project/OnePager/Planisware
- Strong Regulatory Background
- Resource & Budget Planning
- Business Case Development
Timeline
Assoc Dir, Global Program Management (Promoted)
Amgen
06.2020 - Current
Sr. Global Project Manager (Promoted)
Sanofi Genzyme
02.2018 - 06.2020
U.S. Regulatory Manager
Oxford Immunotec
09.2016 - 02.2018
Global Education & Professional Relations Manager
Oxford Immunotec
07.2014 - 09.2016
Application Specialist
Leica Biosystems
05.2012 - 05.2014
Lead Molecular Technologist
STRATADX
12.2011 - 07.2012
Genetics Medical Technologist II
Women And Infants Hospital
04.2007 - 12.2011
MBA -
University of Rhode Island
Bachelor of Science - Clinical Laboratory Science
University of Rhode Island
Certification - Medical Laboratory Scientist
American Society of Clinical Pathology
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