Senior Director – Clinical Operations

Role Overview

• Responsible for all functional activities related to execution of Clinical Trials.
• Lead and oversee a team of internal and external clinical project managers/specialists to meet individual clinical trial objectives and corporate goals.
• Provide operational expertise to project teams.
• 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 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.

Requirements

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• Competitive employment package that includes an annual bonus
• Equity
• Generous benefits package