Diane Mcdowell Email & Phone Number

Copenhagen, Denmark, Dk

Summit, New Jersey, Us

Brentford, Middlesex, Gb

Rahway, New Jersey, Us

• Build US OGMA team from 15 employees to over 40 experienced, oncology experts• Lead team of HQ strategy and field medical to develop and execute US OGMA launch plans.Launched 2nd line lung and melanoma label update for pembrolizumab in 2015. Launched MEC for Emend and HNSCC for pembrolizumab in 2016• Lead cross function collaboration to develop and execute US OGMA plan Create, implement and run best practice programs that are being replicated globally across OGMA including insights collection tool, data summary tool, and US OGMA playbook

Brentford, Middlesex, Gb

Physician Leader Lung Indication and Melanoma Submission Team Tafinlar/Mekinist • Lead regulatory filing for lung indication by collaborating and participating in direct regulatory interaction with FDA and global regulatory agencies including EMA to further registration intent with a breakthrough status agent.• For major melanoma submission, directly and in collaboration with key thought leaders, hands-on author multiple study documents including clinical study reports, scientific publications, protocols and amendments as well as documents for sNDA submissions and prepare responses to questions from regulators. • Principal Medical Monitor for Phase I-III studies in clinical pharmacology, dose finding, and registrational trials. • Create and implement study designs, direct study start up, select study sites, and author and implement protocols in collaboration with principal investigators. Evaluate and respond to investigator questions, direct responses to adverse event/patient safety incidents, review clinical study data, oversee submission of data to medical meetings, and author protocol amendments and train study personnel on implementation of protocol and amendments.

Brentford, Middlesex, Gb

• Leader of Medical Matrix Team, organize, recruit, and train medical affairs staff and champion emerging leaders across all GSK U.S. operations as emerging leader champion. Create and implement plan for successful launch of Tafinlar/Mekinist into US Market.• Lead cross function collaboration to develop and execute USMA plan for combination therapy: Initiate first ever Publication Development Committee to advance secondary analyses of Tafinlar/Mekinist registrational data with melanoma KEEs. Oversee and collaborate on responses to regulatory requests, including the design and implementation of an award winning response to a regulator request for a DHCPL. Create, implement and run best practice programs that were replicated by other therapeutic areas, including a One Medical Meeting for internal engagement and MSL on Demand, an external engagement strategy that received a silver award when implemented by GSK UK.• Principal Medical Monitor for Phase IV studies. Create and implement study designs, direct study start up, select study sites and author and implement protocols in collaboration with principal investigators. Evaluate and respond to investigator questions, direct responses to adverse event/patient safety incidents, review clinical study data, oversee submission of data to medical meetings, and author protocol amendments and train study personnel on implementation of protocol and amendments. • Lead Medical Affairs Support for Commercial:Advance therapeutic area understanding in melanoma by instituting first ever Congress Highlights program. Serve as Medical Point for external communications for Tafinlar/Mekinist, including interviews with industry publications, advocate and help implement first ever patient blogger summit; design and execute medical and product training of Sales Representatives; provide medical copy approval for all marketing materials.

Lawrence Township, Nj, Us

Medical Monitor for Phase III lung cancer trial with ipilimumabMedical monitor for Phase II melanoma cancer trial with ipilimumabResponsible for education of other medical monitors in safety management of ipilimumab

Lawrence Township, Nj, Us

Lead medical affairs activitiesDevelop global medical plan and budgetDevelop publication planDevelop thought leader planMaintain relationship with JV partnersCross functional collaboration with Medical Affairs, Commercial and Access

Lawrence Township, Nj, Us

Matrix Manager for 25-30 employees in 23 European countries with cross functional collaboration with Medical Affairs, Commercial and AccessSupport scientific advisors with education and informationDevelop plan to safely introduce ipilimumab to Distributor Marketsipilimumab EAP educationLiaison between EU medical team and smaller countriesReview trial conceptsThought Leader management and interactions

Lawrence Township, Nj, Us

Lead US Medical Affairs activitiesDevelop US medical plan and budgetDevelop thought leader engagement planDevelop RFP plan in collaboration with Global Medical Affairs and clinical developmentCross function collaboration with Medical Affairs, Commercial and Access

Lawrence Township, Nj, Us

US Medical Affairs lead for launch of ixabepilone in US MarketLead US evidence generation in collaboration with Global Medical Affairs and Medical DevelopmentLead interaction with breast cancer thought leaders on ixabepilone registrational trial dataPhysician leader Bristol-Myers Squibb Foundation Medical Mission to South Africa (2008)Medical Safety team memberBiomarker team member

Philadelphia, Pa, Us

General SurgeonClinical Appointments:Clinical Assistant Professor of Surgery Drexel University College of MedicineClinical Instructor in Surgery (Adjunct) Temple University School of Medicine

Fellowship, Breast Cancer

Surgery

Md, Medicine

Bs, Microbiology

Education record