Job Title: Associate Director, Clinical Operations or Director, Clinical Operations

Reports To: Executive Director, Head of Clinical Operations

Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.

Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.

Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.

Function/Scope:
The Associate Director or Director of Clinical Operations will be responsible for the oversight, management, and delivery of clinical development programs. The responsibilities of this position include the execution of clinical development plans in collaboration with other corporate functions, line management for selected clinical operations staff, managing clinical outsourcing, overseeing financial and budgetary aspects of clinical trials, and will also be responsible for strategic initiatives for process and business improvements. This position will interact internally and externally with executive level management, requiring negotiation of extremely difficult matters.

Duties and Responsibilities Include But Are Not Limited To:

• Provides a leadership role in managing multiple Phase I through Phase IV clinical research trials across all functional areas of the drug development process.
• Oversees and coordinates the operational aspects of ongoing projects to ensure corporate goals of time, cost, and quality performance expectations are met.
• Manages conduct and reporting of clinical studies in Phase I through Phase IV.
• Selection of CROs (and other vendors) and creation of contracts and/or work orders.
• Ensures clinical projects remain on schedule and within budget.
• Develops and reviews strategies for operational efficiencies.
• Reviews budgets, forecasts, and accruals for clinical studies.
• Negotiates budgets and contracts with CROs and investigative sites.
• Reports on study progress to senior management.
• Mentors staff.
• Makes recommendations for staffing needs.
• Attends advisory panels, investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
• Coordinates the on-schedule delivery of clinical trial supplies in collaboration with Pharmaceutical Sciences.
• Responsibilities include interviewing, hiring and training employees; planning, assigning, and directing work; setting objectives; performance appraisals; rewarding and disciplining employees; addressing complaints and resolving problems.
• Liaises with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed.
• Performs other duties as required.

Desired Knowledge and Abilities:

• Must have a demonstrated track record of effective clinical management and leadership.
• Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to:
  • Study initiation procedures.
  • Clinical monitoring functions.
  • Drug safety and regulatory affairs issues.
  • Data flow from sites to data processing, review, and resolution.
  • Analysis and report generation.
  • FDA regulatory requirements (i.e. GCPs, CFRs, etc.).
  • Project management.
  • Financial planning and analysis.
• Demonstrated ability to lead and motivate a clinical team.
• Effective communication, organizational, interpersonal and leadership skills.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
• Must be able to travel up to 20% of time on average, may be higher in accordance with company and/or project requirements.
• Computer skill should include proficiency with Microsoft Office suite of software.

Education and Experience:

• Bachelor’s Degree required, advanced degree preferred (oncology experience preferred).
• Minimum 6 years for Associate Director / 8 years for Director relevant industry experience in clinical/medical research, nursing or pharmaceuticals/devices.
• Minimum 4 years for Associate Director / 6+ years for Director of prior clinical research experience and direct management experience.