Reports To (Position): Senior Director, Clinical Operations
Location: South San Francisco
Department Name: Clinical Operations
HR Designations: Pay Status – Exempt
Objective of Position
This position encompasses a key role in setting and executing on departmental strategy, as well as managing the day-to-day functioning of assigned teams within the Clinical Operations Department.
Essential Duties/ Responsibilities
Program Related Work
- Represents Clinical Operations at the Global Development team and Global Product teams as required.
- Responsible for ensuring protocols can be executed in a compliant manner by Clinical Operations through optimization of assessments, oversight of clinical operations aspects of a clinical protocol. Performs and assists in Sponsor pre-site, site and audit assessments.
- Provides budget, timeline and feasibility support for study protocols until a study team can be established.
- Interfaces with key departments to discuss status of current studies, as well as significant staffing, hospital and recruitment issues. Explores potential upcoming studies, methods for continuing to provide sponsors with the highest quality data, increasing clinic efficiency and setting directions for future growth.
- Oversees clinical trials and study teams to ensure protocols are executed on time, to budget and with quality.
- Establishes and maintains relationships with service providers.
- Negotiates contracts/ rates with identified service providers.
- Works closely with study team on recruitment strategy/issues.
Department related work
- Develops, implements, monitors, and supports Standard Operating Procedures (SOPs) and work processes to ensure an efficient Clinical Operations department.
- Maintains oversight for Clinical Operations staff to establish clear expectations for staff performance, clear delineation of accountability for tasks and processes, and consistent monitoring of work product.
- Meets regularly with Clinical Operations Management to discuss staffing for upcoming studies, sharing of staff between departments, and performance of staff.
- Oversees all hiring, transfers, performance reviews, increases, and terminations in the department for in/direct reports.
- Organizes and/or participates in clinical operations department meetings.
- Reviews, tracks and approves all departmental expenses for in/direct reports.
- Maintains and participates in the fiscal objectives of Clinical Operations and recognizes cost reduction opportunities.
- Manages all aspects of departmental performance improvement strategies including: identifying areas for improvement, developing an action plan in conjunction with all affected areas/staff, and tracking and reporting results to Senior Management.
- Oversees and approves the review, revision, and/or retirement of departmental objectives.
- Maintains and updates knowledge of Good Clinical Practices (GCPs) and their proper application. Reinforces the use of GCPs departmentally through example and staff training.
- Provides support to Business Development and other functions as appropriate.
- Represents Clinical Operations and company at conferences and meetings as appropriate.
- Computer proficiency
- Demonstrated leadership ability
- Meticulous attention to detail
- Strong interpersonal, written/ verbal communication and organizational skills
- Ability to effectively manage time, resources and multi-task
- Bachelor or Master’s Degree in a health-related field
- Eight (8) years related experience in life sciences, including clinical development experience.
- Proven track record as a leader in clinical trials in the biotech or pharmaceutical industry.
- Experience and knowledge of ICH-GCP and other relevant regulations
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.