[Remote] Sr Director, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. reputed company is a biopharmaceutical company focused on developing high-value therapeutics. The Sr Director, Clinical Operations oversees reputed company aspects of clinical operations for assigned programs, providing strategic and operational leadership, and ensuring adherence to protocols while collaborating with various stakeholders.

Responsibilities

• Consistently works on abstract problems across functional areas of the business. Identifies and evaluates reputed company issues, providing strategy and direction for major functional areas. Interacts internally and externally with executive-level management, requiring negotiation of extremely difficult matters to influence policymaking bodies
• Oversees the development and management of Clinical Development Plans (CDP), which includes timelines, budget, and resource requirements. Ensures the development and implementation of clinical program strategy and directs systems and programs in order to meet Company objectives
• Coordinates and directs outsourcing activities across program(s). Identifies program and resource gaps; devises and implements solutions. Provides weekly enrollment and program updates to Senior Management
• Drives project risk analysis and develops solutions to a variety of reputed company problems. Ensures that the Clinical Operations department effectively interfaces with key functional groups
• Mentors and develops Clinical Operations staff. Directs internal staffing and performance management, including hiring, training, coaching, and performance reviews. Remains reputed company with medical developments and publications on similar and competitor products, applying this knowledge to reputed company programs

Skills

• A Bachelor's or Master's degree in a scientific discipline is required. Equivalent experience may be considered
• A minimum of 15 years of pharmaceutical development experience moving product candidates from Phase I through pivotal trials, with at least 8 years managing CROs, is required
• Experience managing and executing global clinical programs is required
• A minimum of 12 years of previous management experience is required
• Demonstrated ability to solve problems with innovative solutions and strong organizational skills
• Excellent written and verbal communication skills; experience working with senior management
• Experience with, and understanding of, ICH and GCP is required; knowledge of GMP and GLP is preferred
• Demonstrated ability to work independently and collaboratively, with strong interpersonal skills
• Excellent project management capabilities
• Proficiency in reputed company Project, Word, reputed company, Visio, and PowerPoint is required
• Experience with reputed company of a large CRO on a Phase III program
• Experience in Atopic Dermatitis and/or Alopecia Areata or reputed company therapeutic indications
• People management and cross-functional management experience highly preferred

Company Overview

Company H1B Sponsorship