Associate Director Clinical Operations and Development

Neurona Therapeutics is an early-stage biotechnology company based in South San Francisco focused on the development

of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a

passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take

part in building an exciting, science-driven company.

Key Responsibilities

• Provide leadership, guidance and direction to the clinical operations team.
• Responsible for tactical implementation of clinical development plans by managing timelines, budgets, and resource requirements.
• Responsible for the development and content of risk mitigation plans to ensure clinical trials are on time and within budget.
• Provide input into Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs).
• Participate in and/or lead CROs/vendors selection process for outsourced activities, including the development of scope of services agreements, budgets, plans, and timelines.
• Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications.
• Participate in or manage vendor governance activities (e.g. governance board meetings).
• Build and maintain program and study timelines, track milestones, monitor overall operational performance metrics.
• Oversee and guide the Clinical Operations team on the identification, qualification, selection, engagement, management, and oversight of study sites.
• Participate in patient recruitment activities and the development of patient recruitment plans and backup plans, e.g., including liaising with patient advocacy organizations
• Identify, recruit, and develop relationships with clinical investigators and site staff in collaboration with Medical Affairs, Medical Monitor and Clinical Operations leadership.
• Oversee contract and budget negotiations with clinical sites.
• Ensure proper development of study databases (e.g. Electronic Data Capture), Tables, Forms and Listings, and other study reports (e.g. patient profiles).
• Oversee/Manage Data Safety Monitoring Boards and other study committees.
• Ensure that all study processes are complete, including training of internal and external resources, and are compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets.
• Develop/coordinate study training for the Clinical Operations team. Ensure study training occurs as needed for the study team, investigational sites, and vendors.
  
  

Department Leadership

• Partner with the VP of Clinical Operations and Development to develop staff and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals.
• Manage and nurture clinical operations staff and direct reports; provide coaching and development opportunities for direct reports.
• Act as a subject matter expert to team members on clinical trial operations/activities.
• Develop and ensure compliance with company SOPs and guidelines, FDA regulations, and current ICH GCP guidelines.
• Identify and implement department process improvements.
• Work with the clinical operations team to identify and develop innovative systems that enhance clinical trials, clinical program management, and/or department efficiency.
• Interface effectively with other groups within the organization.
  
  

Required Qualifications

• Education: Bachelor’s degree (or equivalent) in Life Sciences, Nursing Licensure or Pharmacy, at minimum.
• Minimum of 6 years of clinical operations experience with a thorough understating of cross functional processes, including clinical supply and data management.
• At least 4 years of clinical operations line management experience.
• At least 4 years of experience managing study vendors/CROs. Experience in the Request for Proposal (RFP) process strongly preferred.
• Solid knowledge of drug/biologics development process, clinical study design, study planning and management, and monitoring. Experience in planning, conducting and managing Phase I-III trials.
• Solid knowledge of Good Clinical Practices and ICH guidelines and their application to the conduct of clinical trials.
• Demonstrated experience working on complicated study design such as multiple-arm trials, double-blind protocols, and multi-center research initiatives.
• Solid analytical and problem-solving skills.
  
  

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.

If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.