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Ronald Haberman

Ronald Haberman

MD

Scottsdale, AZ
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Summary

Energetic Pharmaceutical Industry Medical Director skilled in designing and running clinical trials, authoring clinical documents, leading cross-functional teams, medical monitoring, and performing due diligence. Experienced in multiple therapeutic areas including respiratory, cystic fibrosis, cardiovascular (heart failure, antihypertensives, arrhythmia), and anti-infectives.

Key strengths include conceptualization and rapid implementation of strategy with ability to provide oversight of multiple clinical programs simultaneously. Meticulous medical writer, leveraging a certificate in medical writing. Broad medical knowledge and keen medical judgment skills acquired from previous medical practice experience.
CORE COMPETENCIES

 Protocol Development  Life-cycle Management  Medical Writing

 Medical Safety Monitoring  Team Leadership and Development

 Clinical Study Oversight  Strategic Thinking  Due Diligence

Experience

2016 May - Present
Medical Director, Global Medical Affairs
Vertex Pharmaceuticals, Inc. / Boston

• Medical Director over multiple orphan assets in phase 3b and 4 of development

• Global Medical Affairs Lead for cystic fibrosis drug launch

• Global Lead for life cycle management of CF asset

2015 Aug - 2016 May
Medical Director, Clinical Development
Vertex Pharmaceuticals, Inc. / Boston

•Medical Director over multiple orphan assets in phase 1, 2, and 3 clinical trials.

• Designed and initiated POC trials for novel molecule across 2 orphan disease indications
• Set pre-submission ISS/SCS strategy for CF asset in 4 phase 3 trials
• Performed safety Medical Monitoring for multiple concurrent studies
• Created and directed matrix policy-setting task forces
• Co-developed documents and policy with new CRO partner
2014 Mar - 2015 Jul
Medical Director, Respiratory
Allergan (formerly Forest Research Institute) / Jersey City, NJ
Clinical Asset Lead over four drugs in respiratory, cystic fibrosis, and anti-infectives therapeutic areas, with responsibility for strategy and life cycle management. Clinical Lead for early- and late-phase due diligence evaluation of external molecules resulting in negotiated partnership, asset acquisition, or licensing.
• Authored regulatory submissions and presented as Clinical Lead to FDA and EMA
• Managed team of 15 scientists and Study Directors running two concurrent COPD trials
• Evaluated several cystic fibrosis drugs with varying MOAs in due diligences
• Delicately navigated and successfully achieved major protocol revisions with commercial implications for the company's largest active study as Product Development Team Leader
• Assumed efforts for responding to negative Day 150 CHMP opinion, resulting in reversal to a positive opinion and subsequent EMA approval
• Served as Medical Safety Monitor for largest active Actavis trial; 4000 patients projected
2013 Jul - 2015 Jun
Sponsor Consultant
Transcelerate (while at Forest)
Transcelerate is a unique, forward-thinking project that brings together experts across functional lines and from many companies within the pharmaceutical industry, with the goal of standardizing clinical trial protocols and reporting practices across the industry. This will ultimately make cross-trial comparisons more feasible and with less inter-trial variability.
• Authored the core Transcelerate COPD reference document
• Only respiratory physician chosen from the pool of participating pharmaceutical companies
2013 Jul - 2014 Mar
Medical Director, Cardiovascular and Metabolics
Allergan (formerly Forest Research Institute) / Jersey City, NJ

Oversaw development and revision of protocols for cardiovascular (CV) division trials and trials from other divisions with CV outcomes endpoints. Reviewed thorough QT studies and performed CV and QT consultation for non-CV therapeutic areas. CV representative in due diligence review of external molecules.

• Medical Safety Monitor for largest trial ever run by Forest (4161 randomized patients)
• Applied extensive arrhythmia background to advise against in-licensing of a molecule with route and venue as recommended by innovator; saved tens of millions of dollars in costly and precarious development program

Education

STATE UNIVERSITY OF NEW YORK AT STONY BROOK
BS, Biology

BS Biology, STATE UNIVERSITY OF NEW YORK AT STONY BROOK, Stony Brook, NY

POST-GRADUATE TRAINING

Cardiology and Electrophysiology Fellowships, The Lankenau Hospital, Wynnewood, PA

Internal Medicine Residency Chief Residency, Sinai Hospital of Baltimore, Baltimore, MD

Internal Medicine Internship, Mountainside Hospital, Montclair, NJ

RUSH MEDICAL COLLEGE
MD Degree

MD Degree, RUSH MEDICAL COLLEGE, Chicago, IL

Skills

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