VP Alliance Management and Program Management @ Quark Pharmaceuticals Inc
Sr. Director Program Management @ Acerta Pharma BV
Associate Director Project and Lifecycle Management @ Medivation
Indiana University Bloomington
Program Team Lead @ From March 2015 to Present (10 months) San Francisco Bay AreaSr. Director Program Management @ From August 2014 to March 2015 (8 months) Associate Director Project and Lifecycle Management @ Delivers project management leadership for clinical, and lifecycle management. Develops core product plans for oncology indications. Holds dotted line responsibility for all Functional
Program Team Lead @ From March 2015 to Present (10 months) San Francisco Bay AreaSr. Director Program Management @ From August 2014 to March 2015 (8 months) Associate Director Project and Lifecycle Management @ Delivers project management leadership for clinical, and lifecycle management. Develops core product plans for oncology indications. Holds dotted line responsibility for all Functional Area Team Leads charged with program deliverables (CMC, Pre-Clinical, Clinical, Regulatory, Legal, Commercial, and Market Planning). Presents updates on project status to senior management. Oversees risk management and project optimization exercises. Manages interactions with Alliance Partner. Participates/ Facilitates BD evaluations. Manages Direct reports, Develops infrastructure to support sustainable scalable growth. From April 2012 to August 2014 (2 years 5 months) San Francisco Bay AreaGroup Project Manager @ Line manager for PM I & IIs
Lead PM – Portfolio Level Disease Area Strategy Team
Member of PM Senior Leadership Team
Facilitates /Leads Team Effectiveness workshops
Integrated Project Manager for Pre-clinical, Clinical and Life Cycle Management.
Develops and maintains Core Product Plans for Oncology/Immunology Products
Manages Core Team, Development Sub team, Clinical Sub team, and Pharmacology (Non-Clinical) Sub team
Has dotted line responsibility for all Functional Area Team Leads as relates to program deliverables (CMC, Pre-Clinical, Clinical, Regulatory, Legal, Commercial, Market Planning)
Prepares Project status/ triage/ updates to Sr. Management.
Leads Risk Management and Project Optimization exercises
Managed Marketed Product Team through FDA REMs Process
Led Alliance Management interactions for Collaborator Programs with Merck Serono and Roche
Content Team Lead for Department (90 Person) 2 day offsite on integration and problem solving
Involved in the development of training materials for Project Team Leads and PMs From July 2008 to April 2012 (3 years 10 months) Sr. Project Manager @ Integration Lead for Takeda & Tap Pharmaceuticals Project Management, Strategic Operations and Outsourcing Groups.
Project Manager for Pre-clinical, Clinical and Life Cycle Management.
Develops and maintains Clinical Development Plans with cross-functional teams for Genitourinary, Immunology CNS and Metabolic Therapeutic Areas.
Manages program budgets in excess of 150 million dollars
Ensures adequate resourcing for programs.
Runs Regional Development Team Meetings with Clinical Science Co-Chair.
Core Team Member for Global Development Team and new compound Feasibility Assessment Team.
Presents Project status/ triage/ updates to Sr. Management.
Member of Core team for Regulatory interaction (FDA/ EMEA)
Manages various company initiatives to improve productivity and ensure quality deliverables.
Line Manager for Project Specialists and Project Managers From June 2007 to June 2008 (1 year 1 month) Assoc. Director Biomarker Project Management @ Developed Clinical Biomarker Plans with cross functional teams including MDs, PhDs, Statisticians, Regulatory and Life Cycle Management representation, Tracked deliverables for compounds in 5 Therapeutic Areas: CV Met, IM, On& CNS.
Worked with TA teams to design and implement clinical protocols to discover and validate, PD and PGx Biomarkers for use in drug development, marketing and disease management.
Assisted Sr. Management in managing department resource planning (staffing, capital budget, operating budget and alliance budget allocation).
Member of institute wide Portfolio Operations Committee which managed change control (scope, resources, timelines) for the development portfolio
Represented Department on internal and external teams addressing the development of biomarkers (safety, efficacy, PD, diagnostic) from biological samples collected during the clinical trail process.
Interacted with FDA Voluntary Genomic Data Submission (VGDS) team members From August 1997 to June 2007 (9 years 11 months) CRA @ From 1994 to 1997 (3 years) Research Assoc Dir General's Office @ From 1992 to 1993 (1 year) Head Nurse Child Development Center @ Provided technical assistance concerning the referral of children for testing and treatment.
Coordinated outreach work in conjunction with referring agencies (“Tipat Halav”, and local hospitals).
Participated in planning and conducting research projects. From December 1991 to October 1992 (11 months) Graduate Research Assoc @ From July 1990 to October 1991 (1 year 4 months) Graduate Assistant Rollins School of Public Health @ From August 1989 to May 1991 (1 year 10 months) Research Assistant @ Gathered, tabulated and analyzed data relating to the incidence of measles, tetanus, and hepatitis, in Israel.
Initiated a computerized registry for cases of Beta Thalassemia.
Designed data recall form for the evaluation of Hebron Village Health Workers.
Assisted in preparing “Introduction to Research” course for Gaza Public Health Workers. From 1988 to 1989 (1 year) ICU Nurse @ From 1987 to 1988 (1 year)
MPH, International Program Planning @ Emory University From 1989 to 1991 BSN, Nursing @ Indiana University Bloomington From 1983 to 1987 McKinley Sr. High From 1980 to 1983 Julie Friedman is skilled in: Biotechnology Industry, Pharmaceutical Industry, Strategic Planning, Leadership, Therapeutic Areas, Pharmacogenomics, Program Management, Oncology, Research, Budgeting, Global Alliance Management, Regulatory Submissions, CRO, CTMS, Clinical Operations
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