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Program Manager

Location:
Gaithersburg, Maryland, United States
Posted:
November 19, 2018

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Resume:

PAOLA B. CANELOS

**** ***** ***** **., ************, MD 20877 ■ 240-***-**** ■ ac7qn6@r.postjobfree.com

Results-driven program manager with exceptional background in biotechnology, regulatory affairs, and clinical operations management. Solid knowledge of the drug development, approval processes, and the unique requirements for conducting clinical research in domestic and international settings. Specialization in biopharmaceutical business strategy and portfolio management.

PROFESSIONAL EXPERIENCE

AstraZeneca (AZ), Pipeline Strategy Management (PSM) 2016 – Present

Oncology Portfolio Analyst, Associate Director

Effectively develop and manage reports to help improve process, achieve PSM business objectives, support planning and facilitate decision making.

oOncology Portfolio Resource Committee (OPRC): This new tool provided senior oncology leadership with insights around resource gaps, risks and opportunities; Served as a key to the execution of our IO portfolio.

oNew Opportunities: This new tool was used to support new opportunities selection and prioritization process.

oDeveloped and manage to Global Product Team (GPT) tracker to automate and accurately report milestone changes

oManage the Cancer Enterprise monthly report, which provides a high-level overview of the oncology portfolio changes, milestone achievement, goals and financial status. Received acknowledgment from CEO on usefulness and quality of the report.

Successfully managed and led quarterly AZ portfolio review in 1Q2017 and provided insights related to the health and status of the Oncology Portfolio on subsequent 2017 and 2018 AZ portfolio reviews.

Effectively project managed the PIVOT (Portfolio Improvement Valuation Operations Tool) data quality improvement initiative which aligned OPAL/PLANIT and PIVOT definitions and developed the PIVOT data dictionary

Collated and provided data analysis in support of a comprehensive AZ/MedImmune Immuno-Oncology (IO) clinical trials infographic, which for the first time captured and identified aggregate trial information across the IO portfolio in different disease states, stages of development and mechanism of action (mono and combos).

Chief of staff, Head of Oncology Global Product Management (GPM) (Secondment)

oPlan and direct operational activities to the GPM team. Drive consistent and effective communications in alignment with organizational priorities both internally and externally

oOrganize and prioritize critical issues and required information for the department head to facilitate efficient decision making.

oComprehensive knowledge of the overall departmental function, developed department onboarding plan and managed onboarding activities

MedImmune/AstraZeneca 2010 – 2016

Clinical Operations Program Manager, Oncology

Successfully salvaged and delivered a rescue trial by implementing a strategic plan including, establishing appropriate data review plans, training functional members of the study team, and revising study design. Strategies successfully implemented on the project were later incorporated across other oncology programs.

Effectively represented clinical study team on product development team meetings including support of the strategic decision making process at a program level.

Development of departmental guidelines: 1) Timeline and Budget Forecasts Guidelines and 2) Dose Escalation Charter.

Successfully locked a study clinical database 10 days after last subject last visit, which was considered a department record

Co-authored a study published in the Journal of Neuro-Oncology

Established a strategic monitoring schedule that allowed the early collection of clean clinical data that enabled the entire program team to make an early “Go/No-go” strategic decision

Generated a report detailing the CRO’s low quality work, which enabled the sponsor to recoup more than $800,000 of work already paid. (Bronze Award)

Successfully led the study team through difficult enrollment challenges by implementing risk mitigation plans. Completed enrollment within the 12 months, rather than the 18-month delayed enrollment that had been anticipated. (Director’s Award)

Cooperative International Neuromuscular Research Group (CINRG) 2005 – 2010

Clinical Trial Operations Manager/Regulatory Affairs Specialist/ Data Manager

Assumed roles of increasing responsibilities that contributed to further the scientific understanding of Duchenne Muscular Dystrophy and resulted in 4 peer reviewed publications.

As Clinical Trial Operations Manager, played a pivotal role at various phases of clinical studies defining project deliverables, determining resource allocation, developing risk contingency plans, managing study budget and timelines

As Regulatory Affairs Specialist, reviewed trial related documents to assess compliance with global regulatory agency policies, regulations, and standards. Also recommended courses of remediation to help CINRG achieve the necessary levels of compliance.

As Data Manager, efficiently maintained study data quality and integration by providing recommendations for data collection options and overseeing the development of data collection tools (data specifications, eCRF design, user requirements, user management, edit rules/checks, query logic and data validations) based on the clinical study protocol.

Successfully Organized the First Ecuadorian Seminar of Physical Therapy for Muscular Dystrophy

Johns Hopkins University (JHU), Johns Hopkins Lupus Center 2004 – 2005

Manager/Supervisor

Supervised 15 staff members to ensure compliance with study timelines, protocol adherence, and completion of deliverables within project guidelines.

Successfully ensured operational and regulatory integrity of clinical studies through provision of training from study start-up through closure via investigator meetings, CRA training, site visits, and teleconferences.

Played a pivotal role at various phases of clinical studies defining project deliverables, determining resource allocation, developing risks contingency plans, managing study budget and timelines.

Assisted in the negotiation and management of study budgets and the preparation of clinical trial agreements.

SCIENTIFIC AND TECHNICAL ROLES

Food and Drug Administration (FDA/CBER) 2002 – 2004

Research Associate II

Performed and published research on the function of the Xenopus smoc2 gene during embryo development.

Performed and published research on the effects of IL-17 on antigen-induced airways hyperresponsiveness.

Evaluated IL-13 and IL-26 pseudomonas exotoxin tumor therapy for immunogenecity, toxicity, and side effects.

Johns Hopkins University (JHU), Johns Hopkins Asthma Center 2000 – 2002

Research Associate, Clinical Immunology

Established a murine neoantigen sensitization model for evaluation of tolerogenic immunomodulatory manipulations.

Cloned and expressed a novel cytokine gene product.

PODIUM PRESENTATIONS AND PUBLICATIONS

Available Upon Request

EDUCATION

2015 Master of Business Administration, Robert H. Smith School of Business, University of Maryland, College Park, MD

2008 Master of Science, Regulatory Science, Johns Hopkins University, Rockville, MD

2004 Master of Science, Biotechnology, Johns Hopkins University, Rockville, MD

1999 Bachelor of Science, Biology, York College of Pennsylvania, York, PA

AFFILIATIONS AND ACTIVITIES

Clinica San Francisco (Quito, Ecuador) 2003 – Present Member of Advisory Committee, Voluntary Position

Facilitate the collaboration between International and Ecuadorian scientists for the organization of seminar presentations, workshops, and lectures to promote scientific research in Ecuador. Example of activities organized: Hands-on seminar in Physical Therapy for Muscular Dystrophy, Molecular Biology Practical Course at Carlos Andrade Marin Hospital, and Seminar of biotechnology applied to industry and biomedicine

Languages

Spanish (native language), English (fluent)



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