Senior Director Clinical Research Board Resume Cleveland, OH - Hire IT People

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:

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.