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Vice President, Clinical Affairs

ArmaGen Technologies

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Location: Calabasas, CA Posted Date: 4/30/2013 Position Type: Full time Job Code: VP, Clinical Affairs Required Education: Doctorate/PhD Areas of Expertise Desired: Clinical Research

Description

Vice President, Clinical Affairs Job Purpose:
Provide leadership in the design and execution of the clinical studies in the support of the corporate strategy

Vice President, Clinical Affairs Job Duties:
The Vice President, Clinical Affairs is a key position. She/he will lead the planning, development, implementation, execution and interpretations of the Company's Phase 1 and randomized controlled clinical trials (“RCT’s”) in support of the launch of new proprietary products.

Handle all operational tasks for the clinical development of new drug candidates

Serve as the primary interface for all of the company’s clinical development programs with regulatory agencies

She/he will manage the Clinical Advisory Board to assure innovative design of the clinical studies.

She/he will coordinate with the scientific staff, academic partners and Key Opinion Leaders (“KOL’s”), and senior management to ensure RCT strategies are aligned with corporate strategies.

She/he will work collaboratively with research and development and regulatory affairs teams to develop strategies for the regulatory approval of clinical development candidates.

Requirements

1) MD/Ph. D
2) 6+ years of experience in designing clinical trials
3) Pharmaceutical/biotech industry experience
4) Sound experience in clinical operations
5) Knowledge of and experience in regulatory affairs
6) Orphan drug development experience preferred
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