Senior Director/Executive Director Clinical Operations

Primary Responsibilities:

• Directs, supervises and manages all aspects of clinical trials to ensure that corporate and department goals/objectives for clinical development programs are met on time and within budget.
• Interacts with multidisciplinary teams in a matrix environment, developing resourcing, budgeting, financial and strategic planning for clinical programs/studies
• Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
• Responsible for, as directed, strategy and clinical operation sections of regulatory documents including data summarization, protocols, Investigator Brochures, IND annual reports, and others as needed or requested.
• Prepare and present clinical development trial updates to senior management, review any potential issues and propose any mitigations/recommendations.
• Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.
• Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
• Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
• Oversee and maintain the relationships with Contract Research Organizations and investigative sites,
• Participate on project teams and study teams as needed or requested.
• Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Additional Expectations

• Although a remote position, it may be necessary to travel to corporate headquarters up to 2 times per year.
• Ability to travel to clinical sites or to the CRO, as necessary to support trial management.

Qualifications:

• B.A/B.S required; M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.
• Minimum of 10 years for senior director and minimum of 20 years for executive director with progressive advancement within clinical operations in the pharmaceutical/biotech industry.
• Ability to build collaborative relationships with investigators, vendors, and individuals at all levels of the organization.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.