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Medical Manager

Location:
Tucson, Arizona, United States
Posted:
September 17, 2019

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Resume:

Dear Hiring Manager:

With this cover letter and accompanying CV, I would like to express my sincere interest in the Clinical Research Associate position you have available. Combining my MBA in Pharmaceutical Business and 25 years’ experience in clinical development, I am confident in my ability to make a significant contribution to your organization. I have learned about your organization during my work, and I am particularly familiar with the programs and services that your organization has ongoing in the USA and globally.

As you can see from my enclosed CV, I am very skilled in:

• Performing all aspects of oncology clinical studies including; site selection, protocol development, source data verification, and closeout,

• Preparing reports and publications required for product launch,

• Establishing and maintaining good rapport with study investigators and site personnel, and

• Reviewing cases with site staff to determine discrepancies and identify safety issues.

In addition, I possess excellent verbal and written communication skills and strong expertise in MS Word, Excel, and PowerPoint. My exceptional organizational, record maintenance, time-management skills, sense of urgency, and focus on the patient have been recognized by employers many times.

Having worked for a CRO, four global pharma companies, and having positions of increasing responsibility, I would very much appreciate the opportunity of a meeting. I will reach out next week to see if an interview is possible at a time of mutual convenience. In the meantime, please feel free to contact me.

Thank you for your time and consideration, and I look forward to speaking with you soon.

Sincerely,

Rob Friedman

adadmb@r.postjobfree.com

+1-856-***-****

CURRICULUM VITAE

Rob Friedman, MBA, BSc

SUMMARY

A proven leader who will leverage 25 years of experience in: R&D, Medical Affairs, International work, small molecules & antibodies, phase I - IV, and companion diagnostics to ensure successful, on time & on budget projects.

CONTACT INFORMATION

Rob Friedman

9010 E Bear Cub Place

Tucson, AZ 85749

856-***-****

adadmb@r.postjobfree.com

EDUCATION

2011

M.B.A., Pharmaceutical Business and Healthcare Policy, Mayes College, University of the Sciences, Philadelphia, PA

1981

B.Sc. Biology, University of Arizona, Tucson, AZ

PROFESSIONAL EXPERIENCE

VENTANA MEDICAL SYSTEMS, INC., Tucson, AZ

Senior Study Manager, Clinical Operations

Feb 2017 –

Jun 2019

*** Coordinated budgets, headcount and timelines across 15 Pharma Partners, 33 Projects, and 86 studies to ensure consistency and quality

*** Managed international studies, successfully managed Interlaboratory Reproducibility (ILR) study (96% concordance), and

*** Delivered fast study start for projects where cut slide stability was an issue

Possess Chinese work Visa

NOVARTIS ONCOLOGY, King of Prussia, PA

Director, Oncology Medical Affairs

Feb 2015 -

Jun 2015

Led the successful transition of oncology medical affairs responsibilities to the medical affairs staff. Mentored former colleagues on job search strategies. Collaborated with compliance groups to ensure adherence to policies, guidelines and Title 21 of the Code of Federal Regulations.

GLAXOSMITHKLINE, Philadelphia. Naval Shipyard, PA

Director, Research & Scientific Engagement Governance

Oct 2013 -

Feb 2015

Responsible for risk mitigation of third party scientific engagements, coordinated transfer of value (TOV) and research practices risk. Identified methods to capture and report TOV for marketed medicines in investigator-sponsored studies for reporting Medicare and Medicaid services open payments and for pre-approved medicines. Evaluated audit findings to design a paradigm to address scientific booths at medical conventions, encapsulating it into the corrective and preventative actions (CAPA) in the required timeframe.

*** First Line Leader

GLAXOSMITHKLINE, Collegeville, PA

Associate Director/Director, North American Oncology Medical Affairs

Apr 2008 -

Oct 2013

Directed all aspects for the oncology medical affairs franchise including the $31 million budget and eight assets. Provided dotted-line oversight and mentoring to eleven clinical scientists and medical monitors.

*** Reduced annual budget variances from 29% to <3% by instituting rigid budget controls

*** Represented oncology worldwide development on healthcare practitioner Initiative - devised training plan, including global rollout

*** First Line Leader

Authored a white paper on obtaining and processing serious adverse events (SAEs) for investigator-sponsored studies, met with the safety reporting team and executed changes within 60 days to meet safety reporting obligations. Built an alliance with the National Comprehensive Cancer Network (NCCN), providing them access to new compounds and the ability to conducted research studies similar to the CTEP model. Updated New Drug Application Annual Reports Investigational New Drug Applications and Investigator Brochures. Served as Stakeholder for SOP distribution within Oncology unit. Served on Steering Committee to overhaul medical science liaison roles and responsibilities. Served as core member of Global Publications Team. Attended US Military University meetings in attempt to foster potential collaborations between Pharma and Military (Henry M. Jackson Foundation).

GLAXOSMITHKLINE, Collegeville, PA

Senior CRA, North American Oncology Medical Affairs

Oct 2002 -

Apr 2008

*** Responsible for managing investigator initiated (CRT) program working closely with, Safety, Project Management, Regulatory Affairs, Legal, Clinical Operations, Clinical Pharmacology, Statistics, and Commercial to complement R&D efforts

*** Managed collaboration with CTEP (a division of the NCI), overseeing 18 studies in 8 tumor types which enrolled ~2,000 subjects. N.B. brain met study results led to R&D study (potential file)

*** Directed $14M annual budget, manage 76 studies and generated >25 publications (abstracts/posters/manuscripts). CRT committee identified studies that were deemed critical enough to be transitioned into R&D studies

*** Responsibilities included overseeing ~170 phase IV (investigator initiated and collaborative) studies including initial concept, budget (~$7M) and contract, to drug supply for a marketed chemotherapeutic compound

*** Establish collaborative efforts between investigators, cooperative groups and other pharmaceutical companies. Serve on Process Improvement Team in to achieve consistent practices across all therapeutic areas with respect to conduct of investigator initiated / collaborative research studies

*** Worked effectively in a matrix environment with Medical Liaisons, Medical Monitors, Regulatory Affairs, Contracting, Legal, Statistics, Pharmacokinetics, Drug Safety, Commercial Product Manager, Global Commercial Strategy, Health Outcomes, Project Management, Finance, Key Opinion Leaders, and site personnel to ensure quick turnaround time from concept to study start

Invited speaker #3 external conferences on “Maximizing the Value of Investigator Initiated Program.” Addressed SPORE Breast Cancer Committee on potential industry collaborations and new operating paradigms.

Special Project-

Dedicated 10 months working with Prof. E. Perez on a 3,000 subject, Intergroup adjuvant study, Concept was submitted to CTEP on 02 Feb 2006 and reviewed 17 Mar 2006. Responsible for establishing and overseeing all processes (on a global basis) with respect to investigator initiated studies for an IND compound and coordinating collaboration with the Cancer Therapy Evaluation Program (CTEP – a division of the National Cancer Institute) for a development track non-cytotoxic. Led global adjuvant study run through the Intergroup. Spearheaded initiative to review cardiac monitoring data and assess impact on safety profile

WYETH-AYERST RESEARCH, Radnor / Collegeville, PA

Senior CRA, Oncology Research & Development

Oct 1999 -

Oct 2002

*** Led development program for oral chemotherapeutic agent

*** Managed CRAs for site identification, Site Initiation Visits, Interim monitoring visits & close out visits

*** Wrote Clinical Development Plan including Risks/Benefits

*** Successfully worked in global, matrixed environment

ZENECA / ASTRAZENECA Pharmaceuticals, Wilmington, DE

Contract CRA, Oncology Research & Development

Nov 1996 -

Oct 1999

*** Wrote protocols, obtained IRB approval and monitored controlled substance studies

*** Wrote protocols, obtained IRB approval and monitored first time in human studies

*** Coordinated global safety for a 9,500 patient adjuvant breast study

*** Wrote registration protocols for Iressa®

PHILADELPHIA AREA CLINICAL TRIALS GROUP (PACT) / CORNING PACT / COVANCE, Radnor, PA

CRA

Mar 1995 -

Nov 1996

*** Monitored variety of therapeutic areas - ‘Road Warrior’

AWARDS

Risk Management Essentials, Boundless LLC, Michael Brozzetti, President (2013)

GlaxoSmithKline Bronze Award for establishing the Oncology Non-Clinical Review Forum (2012)

GlaxoSmithKline Bronze Award for contributing to Commercial partnership (2011)

GlaxoSmithKline Bronze Award for contributions to New Drug Application – Annual Report (2010)

GlaxoSmithKline Spirit Award for assisting with CRT ‘How-to-Manual’ (2005)

GlaxoSmithKline Bronze R&D Award for managing CTEP collaboration (2004)

Zeneca Research and Development Award for Innovation in Trial Design (1999)

College Scholarship, Phoenix High School of Jewish Studies (1976)

Presidential Citation for Environmental Excellence (1976)

PUBLICATIONS

Molina J, Kaufman S, Reid J, Rubin S, Galvez-Peralta M, Friedman R, Flatten K, Koch K, Gilmer T, Mullin R, Jewell R, Felten S, Mandrekar S, Adjei A, Erlichman E. Evaluation of Lapatinib and Topotecan Combination Therapy: Tissue Culture, Murine Xenograft, and Phase I Clinical Trial Data. Clinical Cancer Research. 2008: 14(23):7900-08

PLATFORM PRESENTATION

Buckner J, Forouzesh B, Rowinsky E, Adjei A, Marks R, Hammond L, Burton J, Boni J, Dukart G, Friedman R. Phase 1 study of oral CCI-779 given daily times 5 every 2 weeks to patients with advanced solid tumors. ASCO Molecular Therapeutics Symposium (9 Nov 2002, San Diego, CA)

POSTER PRESENTATIONS

Cianfrocca M, Kaklamani V, Rosen S, vonRoenn J, Rademaker A, Rubin S, Friedman R, Uthe R, Gradishar W. A Phase I Trial of Pegylated Liposomal Anthracycline (Doxil™) and Lapatinib (L) Combination in the Treatment of Metastatic Breast Cancer (MBC): Dose-Escalation Results of an Anthracycline and Lapatinib Combination Trial. San Antonio Breast Cancer Symposium Annual Meeting (Dec 2009, San Antonio, Texas) Abstract 3096

Cianfrocca M, Rosen S, vonRoenn J, Rademaker A, Rubin S, Friedman R, Rozario C, Gradishar W. A Phase I Trial of Pegylated Liposomal Anthracycline (Doxil™) and Lapatinib (L) Combination in the Treatment of Metastatic Breast Cancer (MBC): First Evaluation of an Anthracycline and Lapatinib Combination. American Society of Clinical Oncology Annual Meeting (03 Jun 2007, Chicago, IL) Abstract 1079

Molina J, Erlichman C, Adjei A, Joy M, Rubin S, Friedman R, Ames M, Reid J, Mandrekar S, Felten S. A phase I study of lapatinib (GW572016) and topotecan in patients with solid tumors. American Society of Clinical Oncology Annual Meeting (02 Jun 2007, Chicago, IL) Abstract 3598

Molina J, Erlichman C, Kaufmann S, Adjei A, Rubin S, Friedman R, Reid J, Qin R, Felten S. Drug resistance to topotecan can be the result of BCRP/ABCG2 expression. American Society of Clinical Oncology Annual Meeting (02 Jun 2007, Chicago, IL) Abstract 3598

Molina J, Adjei A, Erlichman C, Mandrekar S, Joy M, Rubin S, Friedman R, Reid J. A phase 1 study of lapatinib (GW572016) and topotecan in patients with solid tumors. Targeted Anticancer Therapies (17 Mar 2006, Amsterdam, Netherlands)

Erlichman C, Adjei1 A, Joy M, Rubin S, Friedman R, Ames M, Reid J, Mandrekar S, Felten S, Molina J. A phase I study of lapatinib (GW572016) and topotecan in patients with solid tumors. AACR-NCI-EORTC International Conference, Molecular Targets and Cancer Therapeutics (15 Nov 2005, Philadelphia, Pennsylvania) Abstract 8994

Forouzesh B, Buckner J, Adjei A, Marks R, Hammond L, Molpus K, Boni J, Dukart G, Friedman R, Rowinsky E. Phase 1, bioavailability, and pharmacokinetic study of oral dosage of CCI-779 administered to patients with advanced solid malignancies. AACR-NCI-EORTC International Conference, Molecular Targets and Cancer Therapeutics (21 Nov 2002, Frankfurt, Germany)

Rowinsky E, Buckner J, Adjei A, Marks R, Hammond L, Molpus K, Dukart G, Friedman R, Forouzesh B. A Phase 1 study of oral CCI-779 given daily times 5 every 2 weeks to patients with advanced solid tumors. 1st International Symposium on Signal Transduction Modulators in Cancer Therapy (23 Sep 2002, Amsterdam, Netherlands)

PRESENTATIONS

PCP Research Symposium. Advancing Academic-Industrial Partnerships. Philadelphia College of Pharmacy. Philadelphia, PA. 13 May 2014

Clinical Data Management & Standards. A Peer group meeting hosted by Ambassador Jarl Frijs-Madsen, Consul General of Denmark, Danish Embassy, New York City, NY. 01 May 2014

Partnerships in Oncology Clinical Trials, Philadelphia, Linking the Cancer Community through the NCI: Increasing Public/Private Collaboration from the Lab to the Clinic, PA Jan 2009

2008 Clinical Trials Congress, Putting you on the “Fast Track” to Approvals: Strategy, Training, & Execution to Advance the Process. Orlando, FL. February 2008

3rd Successful, Compliant Investigator Initiated Trial Programs – Key Strategies and Tactics for Optimal Outcomes, Preparing your Organization for IITs: Planning and Infrastructure to Attain Maximum Benefit. Philadelphia, PA. Jan 2006

2nd Successful, Compliant Investigator Initiated Trial Programs – Key Strategies and Tactics for Optimal Outcomes, Preparing your Organization for IITs: Planning and Infrastructure to Attain Maximum Benefit. Berkeley, CA. Sept 2005

PATENTS

U.S. / Foreign Provisional Application (60/452,289) filed 05 Mar 2003 for ANTINEOPLASTIC COMBINATIONS

European Patent 04716169.0-2123-US2004006354 filed 01 Mar 2004 for ANTINEOPLASTIC COMBINATIONS COMPRISING A RAPAMYCIN DERIVATIVE AND AN AROMATASE INHIBITOR



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