Head of Clinical Operations
Concentric Analgesics seeks a Head of Clinical Operations, based in the San Francisco Bay Area. The Senior Director, Head of Clinical Operations, provides senior-level operational leadership and oversight for the execution of multiple clinical programs, ensuring efficient delivery of clinical trials in a small company environment. This position manages and coordinates clinical operations activities of direct reports, consultants and CROs and represents the function on project teams. The position reports to the EVP of Program Management & Strategy.
Key Roles & Responsibilities:
Lead and drive the successful execution of all operational components of a fast-moving clinical program using strong project management, leadership and organizational skills.
Be accountable for operational execution across all clinical trials and address and manage risks and issues.
Establish and manage processes to ensure collaborative and aligned activity across functions to maximize effective execution of all clinical research activities
Lead clinical operations strategy
Provide operational input into all clinical development plans to ensure optimal feasibility, speed, and cost-effectiveness of clinical study protocols and global clinical development strategies
Be responsible for negotiation and execution of CRO, vendor and clinical site scope of work agreements and budgets
Track, manage and report on clinical study budgets to include addressing variances, scope changes and status
Provide oversight, selection, and management of CROs, service providers and consultants that are involved in assigned studies
Coordinate the development, review and approval of clinical SOPs
Manage and mentor project/program managers and other members of the clinical operations team to ensure clinical study conduct complies with best practices, guidelines and SOPs
Establish milestones and ensure accurate tracking and reporting of project progress
Plan clinical headcount and address hiring needs to meet program workload demands
Lead initiatives to build clinical department infrastructure. Recommend and implement innovative ideas to increase efficiency and quality of project/program management activities
In collaboration with QA and Regulatory Affairs, ensure that clinical trials are conducted in compliance with applicable regulatory requirements and inspection-ready
Perform other tasks as requested by Concentric Leadership
Knowledge and Skill Requirements:
Requires 12+ years in the biopharma industry with a minimum of 6 years’ experience managing a clinical operations team, with a proven track record of delivering clinical programs on time, within budget
BS/BA degree in life sciences or RN degree
Requires previous experience working in a startup/small company environment
Comprehensive understanding of applicable clinical research regulations globally ICH/GCP (International Conference of Harmonization/ Good Clinical Practice)
Experience interacting with/presenting to senior management teams, internal and external (CRO or partners)
Extensive experience in designing, managing, problem-solving and executing clinical trials.
Knowledge of clinical research process and methodology, market research strategies and technologies as well as competitive strategies
Proficient in MS Excel, Word and PowerPoint
Established ability to prioritize and manage multiple tasks simultaneously; demonstrated ability to identify and resolve issues, and effectively manage timelines.
Strong organizational skills, proven effectiveness in a quick-changing, fast-paced environment
Excellent communication and interpersonal/team skills
Position is based in San Francisco
Ability to travel up to 25% of time
Click here to apply.