Executive Director, Dermatology Strategy And Operational Excellence
Current
Jun 2022 - Present
AeroLeads people directory · profile
Amy Blithe Email & Phone Number
Executive Director, Dermatology Strategy and Operational Excellence
at
Incyte
1 work email found
@comcast.net
1 phone found area 302
LinkedIn matched
4 data sources
Profile completeness 100%
Current company
Role
Executive Director, Dermatology Strategy and Operational Excellence
Location
Wilmington, Delaware, United States
Who is Amy Blithe? Overview
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Quick answer
Amy Blithe is listed as Executive Director, Dermatology Strategy and Operational Excellence at Incyte, based in Wilmington, Delaware, United States. AeroLeads shows a work email signal at comcast.net, phone signal with area code 302, and a matched LinkedIn profile for Amy Blithe.
Amy Blithe previously worked as Senior Director, US Medical Affairs Operations and Program Management at Incyte and Director, US Medical Affairs Operations and Program Management at Incyte. Amy Blithe holds Bachelor Of Science (Bsc), Dietetics And Clinical Nutrition Services from University Of Delaware.
Company email context
Email format at Incyte
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{first}{last}@comcast.net
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AeroLeads found 1 current-domain work email signal for Amy Blithe. Compare company email patterns before reaching out.
Profile bio
About Amy Blithe
Senior Director of US Medical Affairs Operations and Programs. Demonstrated success in Clinical and Medical Affairs Operations Management, Strategy Planning and Execution of medical affairs activities, including IIRs, advisory boards, medical education initiatives, launch readiness and ongoing lifecycle medical activities, congress activities, expanded access programs. Strong program and project management professional with a Bachelor of Science (BSc) focused in Dietetics and Clinical Nutrition Services from University of Delaware.
Listed skills include Clinical Research, Gcp, Cross Functional Team Leadership, Protocol, and 12 others.
Current workplace
Amy Blithe's current company
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12 roles
Amy Blithe work experience
A career timeline built from the work history available for this profile.
Senior Director, Us Medical Affairs Operations And Program Management
Jun 2021 - Aug 2022
Director, Us Medical Affairs Operations And Program Management
May 2018 - Jun 2021
Associate Director Medical Affairs, Operations And Program Management
Aug 2016 - May 2018
Senior Medical Operations And Program Manager
- Provides direct project management support for the following MA operational programs: 1. Independent Investigator Sponsored Trials: tracks, monitors, and participates in clinical study protocol processing, study.
- Contributes to the overall project management of the remaining MA programs (to include Publications/HEOR, Medical Information, Advisory Boards, etc.), and assists in the development and review of project timelines.
- Collaborates seamlessly with the MA home office team, regionally based science liaison team, internal cross-departmental colleagues/stakeholders and external consultants/vendor representatives to ensure timely, quality.
- Assists in supporting cross-functional communication among the MA functional teams through appropriate methods 1. Sets meeting logistics 2. Prepare meeting agendas and minutes 3. Ensures MA team plans and activities.
- Assists in the monitoring and management of MA programmatic financial and contracting activities
- Develops and applies metrics for deliverables under his/her purview.
Feb 2012 - Aug 2016
Senior, Cra
Incyte Corporation
- Provide direct project management support to insure effective and efficient start-up, conduct and close-out of clinical trials in collaboration with CRO/Clinical Project Manager
- Partner with CRO/internal team to develop and acquire essential study documentation including the review and approval of CIRB/LIRB ICF templates and required regulatory documentation
- Assist Clinical Project Manager in the tracking/review and approval of site contracts/budgets
- Partner with CRO/internal team for development and maintenance of monitoring plan/ SOPs to guide in the management and review of monitoring activities at investigational sites; review monitoring trip reports and.
- Establish study priorities and help ensure study timelines are met across multiple studiesParticipate in UAT of vital systems, (IVRS, EDC –Inform), data review and discrepancy resolution
- Participate in weekly Sponsor/CRO/vendor teleconferences/web meetings to proactively identify implications of study progress; review and approval of agenda/minutes
Jan 2010 - Feb 2012
Independent Consultant, Clinical Research Associate At Astrazeneca
Omnicare Clinical Research
- Collaborate with Clinical Operations functional groups (Regional Monitors, Medical Monitors, Marketing Company Leads, Site Managers, colleagues in Sweden, Brazil, South Africa, Ukraine and Philippines) to ensure on.
- Work with the Clinical Operations functional groups to obtain missing source documents, request corrected documents, follow-up on Independent Central Adjudication Committee (ICAC) questions and develop plan to ensure.
- Monitor source documents and Electronic Data Capture through Sponsor’s Endpoint handling system, collating the information into complete end point packages and submitting to ICAC
- Monitor data entered by sites into Sponsor's electronic data capture system (RAVE) against source documents for consistency and accuracy, query resolution
- Assist Sponsor with maintaining relationships and monitoring performance of CRO endpoint team reviewers
- Participate and often present weekly Sponsor and Omnicare teleconferences/web meetings to proactively identify implications of study progress
Oct 2008 - Apr 2009
Study Delivery Operations Specialist At Astrazeneca
Yoh Company Technology Staffing
- Management of 25 to 30 sites, including site selection, study start-up, conduct, close-out, clinical trial materials, eCRF data management, recruitment and retention
- Trained and supervised Global study delivery team/CRO in identifying, collecting and processing of endpoints submitted to ICAC
- Assisted sites, internal and external partners with SAE and endpoint submission
- Reviewed SAE and endpoints for submission to patient safety and ICAC
- Managed customer relationship with sites, CRO and third party vendors
- Liaised with sponsor personnel, proactively identifying to and resolving with the SDL issues which may impact the delivery of the study to meet the necessary quality, time line and budget objectives
Dec 2006 - Oct 2008
Study Delivery Operation Specialist/Clinical Research Scientist At Astrazeneca
Smith Hanley Consultants
- SAE narrative writing according to corporate and regulatory requirements
- SAE and database reconciliation, QA/QC of SAE reports and CRF's
Jul 2006 - Nov 2006
Clinical Research Coordinator
- Managed and conducted 9 clinical research trials
- Completion and submission of regulatory documents
- Liaised with Sponsors, CROs, and IRBs
- Recruited subjects through advertising, physician referral, and existing database
- Created and completed study source documents, CRF, eCRF
- Completed patient visits in accordance with protocol guidelines, to include informed consent process, diagnostic testing, drug dispensing and inventory, blood draw, processing and shipping
May 2004 - Apr 2006
Registered Dietitian And Certified Personal Trainer
Sole Proprietor
- Marketed nutrition and fitness services to the community
- Presented group lectures to medical professionals, schools, organizations, and corporations
- Developed computerized nutrient analysis and individualized dietary and fitness plans
- Created educational material for disease management and sports nutrition
- One-on-one personal training of clients
Jan 1998 - Dec 2004
Instructor Of Anatomy And Physiology
Delaware Technical Community College
- Development of lesson plans for all course material
- Course instruction for two classes each with 30 students
- Course instruction for four lab classes each with 15 students
- Grading, counseling of students
Jan 2004 - Jun 2004
2 education records
Amy Blithe education
Bachelor Of Science (Bsc), Dietetics And Clinical Nutrition Services
University Of Delaware
Education record
William Penn Highschool
FAQ
Frequently asked questions about Amy Blithe
Quick answers generated from the profile data available on this page.
What company does Amy Blithe work for?
Amy Blithe works for Incyte.
What is Amy Blithe's role at Incyte?
Amy Blithe is listed as Executive Director, Dermatology Strategy and Operational Excellence at Incyte.
What is Amy Blithe's email address?
AeroLeads has found 1 work email signal at @comcast.net for Amy Blithe at Incyte.
What is Amy Blithe's phone number?
AeroLeads has found 1 phone signal(s) with area code 302 for Amy Blithe at Incyte.
Where is Amy Blithe based?
Amy Blithe is based in Wilmington, Delaware, United States while working with Incyte.
What companies has Amy Blithe worked for?
Amy Blithe has worked for Incyte, Incyte Corporation, Omnicare Clinical Research, Yoh Company Technology Staffing, and Smith Hanley Consultants.
How can I contact Amy Blithe?
You can use AeroLeads to view verified contact signals for Amy Blithe at Incyte, including work email, phone, and LinkedIn data when available.
What schools did Amy Blithe attend?
Amy Blithe holds Bachelor Of Science (Bsc), Dietetics And Clinical Nutrition Services from University Of Delaware.
What skills is Amy Blithe known for?
Amy Blithe is listed with skills including Clinical Research, Gcp, Cross Functional Team Leadership, Protocol, Clinical Study Design, Training, Management, and Project Management.
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