Associate Director/Director, Clinical Operations - The Steely Group

Associate Director/Director, Clinical Operations

Job Overview
We are looking for a talented and highly motivated Clinical Operations professional to join our client's fast-paced biotech startup. Under the direction of the Executive Director, Clinical Operations, this role will support and manage several aspects of one or more AAV gene therapy clinical trials, including engagement and direct oversight of the clinical centers, investigators, study coordinators, and clinical CROs. The role is responsible for actively contributing to the development and implementation of the strategies and timelines needed to achieve targets and goals, as well as managing the clinical budget. This role involves cross-functional collaboration with other departments, such as regulatory, drug manufacturing, quality assurance, non-clinical, etc.  Must be comfortable with operational details and site management. Flexibility of thought and excellent problem-solving skills are required.
 
Job Responsibilities

• Under the direction of the Executive Director, Clinical Operations, manage all aspects of one or more clinical trials (interventional, natural history, investigator-initiated trials) to ensure clinical operation activities are completed in compliance with SOPs, regulatory requirements, and ICH regulations.
• Lead external study teams to ensure efficient and high-quality clinical trial execution. 
• Evaluate and implement strategies to mitigate and solve deficiencies in clinical timelines, budgets, and quality.
• Handle project planning, budget, and resource management for clinical studies. Partner with legal and financial functions to negotiate study contracts and budgets. Oversee site budget and contract negotiations.
• Assist with CRO and vendor selection for assigned projects. This includes ongoing financial review (e.g. monthly actual and forecasted spend, invoice approval, etc.).
• Model the timing and budget implications of various clinical program strategies.
• Assist in preparation of clinical study reports, annual reports, Investigator’s Brochure updates, as well as other regulatory documents.
• Ensure appropriate Sponsor oversight of the development of case report forms (CRFs), data edit checks, patient profile design, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis.
• Evaluate, manage, and facilitate the timely flow of clinical data to support program objectives.
• Maintain frequent contact and work effectively and efficiently with all study stakeholders, including investigators, vendors, and internal staff.
• Oversee forecasts to maintain sufficient clinical and non-clinical supplies.
• Work in close cooperation with CMC and Quality Assurance to ensure timely manufacturing, packaging, labeling, and shipping of supplies for the clinical trials.
• Partner with Quality Assurance to ensure compliance with GCP, GMP, and regulatory guidelines.

 
Education, Experience & Skills Requirements

• B.A. / B.S. in a life science major. An advanced degree is preferred.
• 7+ years clinical operations experience in a biotech or pharmaceutical company.
• Experience with effectively facilitating team meetings to drive study progress.
• Experience developing study execution strategies, risk mitigation, and successful site / country selection.
• Outstanding written and verbal communication and presentation skills.
• Extensive knowledge of clinical study methods and cross-functional needs.
• Ability to multitask as needed in a start-up environment.
• Exceptional work ethic, dedication, and sense of urgency with the ability to thrive in a fast-paced environment.
• Exemplary critical thinking, planning, organization, and time management skills including the ability to support and prioritize multiple projects.
• Desire to broaden expertise with an ability to adapt and apply skills to new challenges.
• Experience in clinical trial operations and study data reporting.
• Ability to effectively manage CROs and other vendor performance and budgeting.
• Knowledge of the drug development process, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to work independently and collaboratively with internal teams, CROs and other key stakeholders, as required, in a multidisciplinary team environment.
• Strong leadership and management skills.
• Exceptional process and project management skills.
• Strong problem-solving ability with a “can-do” attitude.
• Ability to think strategically as well as master the details.
• Proficient with Microsoft Office.

Compensation will be determined based on relevant skills and experience, but we are targeting a Base Salary of $200-225K for this role.