• Address: Aliso Viejo, CA 92698 (map)
• Date Posted: 11/04/09
• Job Type: Full-time

Company:

Job Title: Director/Senior Director, Regional Clinical Research - Irvine, CA

Job Code: CR31849

Location: Irvine, CA 92602

Job Description:

Director/Senior Director, Regional Clinical Research




Our client is a global healthcare company that develops and commercializes specialty pharmaceutical products for the ophthalmic, neurological, dermatological and other specialty markets. The Company operates in specialty pharmaceutical research, targeting products and technologies related to specific disease areas such as glaucoma, retinal disease, dry eye, psoriasis, acne and movement disorders. In addition, it develops and markets aesthetic-related pharmaceuticals and over-the-counter products. The company also focuses on research and development efforts on new therapeutic areas, including gastroenterology, neuropathic pain and genitourinary diseases.



Job Description


The Director/Sr. Director, Regional Clinical Research will be responsible for leading and managing the clinical site management and monitoring (CSMM) activities in North America. They will lead, manage, develop and motivate Regional Area Managers and their staff to deliver on all clinical trial commitments in the geographic area assigned. Deliverables include Regional Strategic Plan, including but not exclusive of, resource plans, budget, goals, processes and standards, quality management, and oversight plans for external operations partners and Global study placement recommendations. The Regional Director is responsible for creating the CSMM long-term regional strategic plan and provides input to senior management to contribute to the overall GDO strategic plan. The regional strategic plan includes, but is not limited to: Determining annual regional goals in accordance with global and local clinical trial commitments, GDO objectives and Company's corporate goals; Evaluating the region's capabilities, potential and opportunities (e.g. unmet medical needs), in collaboration with other groups; Selection of local or regional external partners, and approving oversight plans, for site management and monitoring services; Developing a strategy for building and maintaining relationships with KOLs, clinical study sites, medical groups and relevant agencies/institutions; and Identifying regional performance metrics.

The role is also responsible for building and maintaining Company capabilities for clinical trial conduct in the region. In addition, the role promotes and facilitates the sharing of best practices, lessons learned and process improvements among countries and functional groups. Further, the role develops, and/or contributes to the development and maintenance of, relevant policies, guidelines, forms, SOPs and business practices within region.



Job Requirements M.D., Ph.D. or other advanced degree/equivalent life experience relevant to healthcare and clinical science Minimum of eight (8) years of pharmaceutical experience (some years within the region preferred) Minimum of two years of managerial experience Demonstrated success in project management and/or clinical trial planning and execution Working with global project teams Finance, budget planning and expenditure management Process improvement, organizational development and change management Basic scientific/medical/clinical knowledge In-depth understanding of the drug development process, clinical trials conduct, Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations, when country-based Regional expertise Cross-cultural knowledge Good understanding of clinical study budgeting and finance Detailed understanding of customer service as it applies to clinical research Extensive understanding of project management principles and implementation Familiarity with time, cost and quality metrics Bilingual Spanish required


ExperienceMinimum of eight (8) years of pharmaceutical experience (some years within the region preferred) Minimum of two years of managerial experience


Education and Training M.D., Ph.D. or other advanced degree/equivalent life experience relevant to healthcare and clinical science


Salary: $150 - $170K annual. D.O.E. and company car provided.



Medical Staffing Network is one of the largest and most reputable Clinical Research staffing agencies. As an MSN employee, you’ll receive great pay and top benefits.


Why choose Medical Staffing Network? 401K Major Medical, Vision and Dental Insurance Life Insurance and Short Term Disability Liability and Workers' Compensation Enjoy: Great locations/ prestigious facilities Exclusive partnerships


APPLY NOW, email your CV or resume to clinicalresearch@msnhealth.com, or contact us at (877) 605-2500.

For quick consideration apply here: http://www.cytiva.com/ihire/ext2/applya.asp?ihire?ihireCR31849?rockville?28


Facility:

Facility Address:

Irvine, CA 92602



Posted By: Medical Staffing Network


In just seven years, Medical Staffing Network has grown to become a national leader in healthcare staffing, with over 120 locations nationwide. This enables MSN to offer nurses, allied health, pharmacy, clinical research and anesthesia professionals a variety of flexible opportunities at thousands of top facilities nationwide. We were also the first national-level healthcare staffing firm to have received Joint Commission certification, which we obtained in 2005 and again in 2006.

In addition to competitive pay rates, Medical Staffing Network offers healthcare professionals many of same benefits they'd receive as a staff employee—with the added flexibility and choice that comes with working with a staffing firm. Opportunities are available on a local per diem, travel, temp-to-perm or contract basis. Benefits can include health insurance, malpractice insurance, matching 401(k), free online continuing education credits, direct deposit, bonuses and more. We have the power to offer healthcare professionals opportunities that smaller firms can't. For more information or to apply online, visit www.MSNHealth.com or call 800-MSN-TEAM (676-8326).

Medical Staffing Network

Boca Raton, FL 32819

United States of America

URL: http://www.msnhealth.com Application URL: http://www.cytiva.com/ihire/ext2/applya.asp?ihire?ihireCR31849?rockville?28

Email: info@msnhealth.com

Phone: 800-676-8326