Senior Director Clinical Research Board Resume
Cleveland, OH
SUMMARY:
- Research and Development leader with 20 years, broad, pre clinical and clinical experi - ence in pharmaceuticals, diagnostics and medical devices, trial and alliance management in the pharmaceutical, biotech, imaging and diagnostics industry.
- Committed to the growth and success of a commercial-stage, clinically-oriented organization.
- Leader of high performing intercultural, interdisciplinary research groups and core facilities, 60+FTE, $15M annual budget.
- Manager of global project and clinical affairs teams, innovation programs; drug and medical device product approval and launch.
- Set up and management of up to $50M public private partnerships, alliances, and cooperations with pharma, biotech, IVD and MedTech companies, CROs, academia, grant agencies including strategy, contracting, monitoring, steering committees.
- Author of numerous publications in highly regarded scientific journals and book series; conference chair and speaker; patents; Key Opinion Leader networks.
KEY SKILLS AND COMPETENCIES:
Drug and Biomarker Development | Medical Devices | (Companion) Diagnostics (IVD, NGS, Imaging, Histopathlogy) | Image-guided Therapy | Drug Delivery | Healthcare IT | Biochemistry, Molecular and Cell Biology | ‘Omics | Pharmacology and Toxicology | Medicinal and Radio-Chemistry | Oncology, Cardiology, Inflammation | Regulatory and Clinical Affairs | Medical Device Regulations | Mini-MBA | Six Sigma, Kaizen, Lean, Agile
EXPERIENCE:
Senior Director Clinical Research Board
Confidential, Cleveland, OH
Responsibilities:
- Manage hands-on annually ca.20 clinical validations, approvals and product releases
- Acquired 4 major Ohio Third Frontier and multiple federal grants totaling $M15.
- 2 major corporate process designs and roll-outs as Business Excellence Framework Expert for Innovation Partnerships and Biomedical Experiments.
Senior Director Bio Molecular Engineering
Confidential
Responsibilities:
- Transformed within 2 years 40 Confidential technology group into a high performing medical application development team, built and managed 22k Confidential Life Science Facility.
- 4 major product developments, 2 successful internal ventures and 2 spinouts.
- Managed $7M collaborations with pharma; delivered multiple imaging, biomarker, companion diagnostics and drug delivery development candidates to partnership.
- Led multiple public private partnerships: business plans, operational lead for “Center for Translational Molecular Medicine” Dutch initiative with 15 Confidential led consortia (total $70M). Won multiple national and EU based grants ( € 11M), prestigious EuroNanoForum Best Research Project Award for NanoDrugs ” .
Confidential
Head of Technology Management
Responsibilities:
- Led 9 month discovery technology review with savings and reprioritization of 25%.
- Established biomarker strategy for oncology and approval of oral Confidential drug Confidential .
- Cofounded company’s first cross-disciplinary Clinical Experimental Medicine Group.
Director of Functional Screening
Confidential, Waltham, MA
Responsibilities:
- Built from scratch within 1.5 years Confidential infrastructure and own functional screening group to identify and validate novel drug targets; delivered thereof annually more than 5 to HTS and multiple biomarker candidates to all clinical indication groups.
- Led more than 10 collaboration programs and technology transfers with biotech partners within budget and exceeding timelines and deliverables by ca. 30%.
- Selected for corporate high potential development program as only R&D affiliate.
Laboratory Head
Confidential
Responsibilities:
- Oversaw hands-on and as Joined Steering Committee Member $4M genomics colla-boration and technology transfer with Confidential, all milestones met on time.
- Led ‘omics analytics in antimicrobials program for target identification and hit to lead development. Received multiple recognitions for delivering first whole genome sequences and expression profiles within 1 year with more than 20 novel drug targets selected and over 100 pharmacogenomics lead compound profiled.