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 Erol Onel, M.D. is an experienced physician with strong clinical and academic background coupled with industry experience (all phases: 1, 2, 3a, 3b, and 4 in both large and small pharmaceutical companies) and corporate/market focus, who can bring leadership across therapeutic areas, speed drugs and devices to market, and expand product life-cycles.
Dr. Erol Onel’s current and past professional roles.
Erol Onel, M.D. Senior Director, Medical Affairs
(Pain, Post-Operative Care, Central Nervous System, Oncology)
- Provided scientific leadership to Research/Development and Established Product divisions
- Formulated strategic evaluations of internal and external product opportunities and clinical strategy
- Provided medical input to safety and pharmacovigilance groups
- Assisted in authorship multiple NDA submissions, clinical trial protocols, Investigator Brochures, and PSUR documents
- Oversaw multiple phase 3 clinical trials of 600-700 subjects; multiple phase 2 trials of 45-150; and multiple phase 1 trials of 16-100; completion ahead of schedule and under budget
- Expanded vendor environment to include national and international participation
Led national and international advisory board and CRO meetings
- Assisted in authorship of over 20 published posters, abstracts, and peer-reviewed papers
Erol Onel, M.D. Director, Medical Affairs (Surgical Sub-Specialties, Urology, Orthopaedics)
- Started and provided scientific leadership to Urology division; provided scientific leadership to Orthopaedics division
- Founded team to purchase initial Urology product; doubled sales from $7 Million to $15 Million
- Dramatically increased main Orthopaedic product revenue from $14 Million in 2006 to $36 Million in 2007, partially due to inclusion of Rheumatologists, PCPs, and PMR specialists
- Managed successful interactions with FDA and EMEA with team of 14 MDs, PhDs, RNs, and MBAs resulting in approval of New Chemical Entity (Degarelix) for treatment of prostate cancer
- Compiled and prioritized existing and new data into cogent and profitable action plans
- Authored and designed clinical development plans, study protocols, and training materials
- Established external presence with manuscripts, abstracts, and presentations at international meetings (Urology: AUA, ASCO, GU Cancer Symposium, IPPS; Orthopaedics: AAOS, ACR, OARSI)
- Medical leadership to national sales force of 80 sales representatives plus telesales
- Led national advisory board meetings and provided speaker training (international faculty of 60)
- Worked with business development on identification and due diligence of new acquisitions
- Initiated plan with Europe to rescue pipeline products
- Assimilated and critically evaluated physician, managed care, and consumer input to partner with sales and marketing in creation of new, scientifically-based advertising campaign
- Critical role in facilitating and maintaining positive inter-departmental communications (notably with regulatory, marketing, sales, sales training, manufacturing, managed care, distribution, and legal departments) and external communications with vendors, agencies, and KOLs
Erol Onel, M.D. Senior Associate Director, Clinical Operations (General Medicine: Female Sexual Dysfunction)
- Trial Clinical Monitor for 975 subject and 4000 subject Phase 3 trials
- Exceeded recruitment goals by 200 subjects in three months less than allotted
- Managed $13 Million and $42 Million projects ahead of time and under budget
- Primary role in guiding department when Director position vacant
- Facilitated inter-department and external communications
- Authored study protocols, NDAs, and clinical development plans
- Led team of 11 MDs, PhDs, and RNs in finding creative solutions to FDA & EMEA requests
- Authored, validated, and published new ratings scales and outcomes instruments
- Regular interaction with clinical trial investigators, industry experts and thought leaders
- Designed worldwide safety data reporting process, form, and database in 13 countries
- Reviewed SAE reports, reviewed and wrote patient narratives
- Potential for $9 Million increase in company revenue by decreasing time to market 90 days
Erol Onel, M.D. Assistant Professor of Urology (Male Fertility, Male and Female Sexual Dysfunction)
Managing Partner of Private Urology Practice
- Maintained busy academic and private schedule
- Led community service and resident education programs
- Crafted budget for private clinic, leading to first balanced budget
Assistant Professor of Urology (Chief, Division of Andrology and Sexual Dysfunction)2003
Assistant Professor of Pathology
- Maintained busy academic schedule
- Led resident teaching program; honored twice in four years as “Teacher of the Year”
- Founder and Director, Andrology Laboratory
Clinical and Research Fellow in Urology: Andrology and Sexual Dysfunction
Resident in Urology
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