Associate Director/Director Clinical Operations

Our Culture: Why work with us?
We value the diversity of backgrounds, ideas, opinions, and life experiences that our team members bring to Candel. We are incredibly proud that as we have grown, our vibrant culture has remained steadfast. Our Leaders are accessible, authentic, and invest in their employees.
Our Science
Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors with a robust pipeline. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life. Please visit www.Candeltx.com for additional information.
What Is In It For You
The Associate Director/Director, Clinical Operations, partners with Clinical Research, Medical Affairs, and Development functions, and ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies, and regulatory guidelines to provide timely delivery of high-quality clinical data. The role supports and manages. This position manages and mentors some CRA/CTM or other direct reports and supports their professional development. This role functions independently with little supervision and high visibility. This individual should be able to recognize when escalation for issues related to quality, timelines, and budget is required or beneficial and will provide recommendations for the resolution of these issues. This role, reporting to the VP Business and Clinical Operations, has the ability to make an impact internally and externally.
A Day In The Life Of This Role

• Participates in the development of SOPs, Clinical Study Reports, NDAs, and other clinical documents
• Supports strategic outsourcing by participating in strategic vendor governance, including identification and resolution of performance issues
• Acts as a role model for Candel´s values
• Create and drive trial-level timelines (including patient recruitment plan), and create and execute operational gap, risk management, and mitigation plans
• Ability to initiate, participate in, and/or lead cross-functional study management teams or interdepartmental strategic initiatives and should have good influencing skills with study stakeholders
• Contribute, along with relevant functions, to the design and strategic implementation of clinical protocols and ICFs, and data collection, quality, and management systems
• Identify, measure, and report on clinical program benchmark key performance indicators (KPIs) such as, but not exclusive to clinical synopsis development, finalization of clinical protocols, CRO contracting, patient screening, first patient enrolled, last patient enrolled, data lock, report finalization
• Ensure successful completion of clinical activities and deliverables within the required time frame and budget

What We Will Need From You

• Experience in managing, mentoring, and developing staff is required
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
• Excellent interpersonal skills and a demonstrated ability to lead are required
• Experience in company-sponsored clinical trial management is essential with oncology development experience preferred
• A thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
• Experience in developing RFPs, selection of CROs/vendors, and management of external resources
• Ability to examine functional issues from a broader organizational perspective with an ability to search for solutions
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
• Strong communication and influence skills and the ability to create a clear sense of direction are necessary
• 10+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline
• A positive and motivated attitude is a must

What will make you a good fit with this role:

• Comradery: You build genuine relationships. You trust your co-workers. You genuinely enjoy working together and understand we are all more successful when we work as a team
• Perseverance: You have a “can do” attitude and do not mind rolling up your sleeves and pitching in. You always go above and beyond
• Intellectual curiosity: You enjoy thinking deeply. You have a thirst for learning. You relish sharing knowledge and know how to have fun doing so!
• Daring: You are comfortable taking risks and (appropriately) pushing boundaries. You work hard and challenge the status quo

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