Valeant Pharmaceuticals

Executive Director, Clinical Operations & Development

US-NJ-Bridgewater
Job ID
9000
Category
R&D
Pos. Type
Full Time

Overview

Executive Director of Clinical Operations & Development is responsible for leading and directing clinical studies and development programs at Valeant. Executive Director will be expected to manage internal and external clinical teams, identify, select, and manage contract resources necessary to successfully accomplish this function. Must have demonstrated capacity to lead with minimal supervision, communicate effectively, think strategically, and drive for results. Executive Director will also support R&D leadership by assessing clinical components of potential business development opportunities and also assist in integration activities as deemed necessary by the CMO/Head of R&D.

Responsibilities

Lead internal/external multidisciplinary teams on clinical operations & development initiatives
• Develop and implement strategies ensuring clinical trial objectives are met within prescribed time and funding parameters
• Proactively identify risks to timelines and budgets, and develop contingency plans to address issues
• Apply clinical trial management skills across entire clinical team
• Manage program issues with contractor teams and R&D management as necessary
• Develop responses to external inquiries (e.g., regulatory authorities, IRB’s, etc.)
• Direct preparation of clinical components of regulatory submissions, develop and participate in presentations at FDA meetings/discussions
• Support R&D management with research/input on clinical development issues associated with potential partnerships and acquisitions
• Maintain high quality and ethical standards for design, conduct, analysis and results reporting for all drug and device clinical development projects

Qualifications

• Minimum of 15 years clinical research experience in pharmaceutical company, with demonstrated increases in competencies and responsibilities, including management of regional/global programs across diverse therapeutic areas
• Well organized with strong management and leadership skills
• Professional degree in life sciences, or commensurate experience
• Demonstrated experience in clinical trial initiation, maintenance, and close-out of successful (Phase II-IV) NDA programs
• Proven ability to interpret and analyze scientific data and finalize/approve scientific documents

• Excellent written and verbal communication skills to meet needs of varied audiences
• Strong interpersonal skills commensurate with the need to work closely with partners, contractors, consultants, and internal team members
• Ability to successfully manage multiple clinical projects across therapeutic areas
• Must be able to manage multi-million dollar budgets
• Must have global experience

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