VP, Clinical Development, Medical Development Leader – Late Stage

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early- to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Candel is a newly public company having completed its IPO at the end of July 2021. Please visit www.candeltx.com for additional information.

VP, Clinical Development (late stage) is a critical leadership role within Candel Therapeutics, reporting to the Chief Medical Officer (CMO) and working closely with the Leadership Team and the VP, Development leader (early stage) to build a fit-for-purpose Clinical Development organization that delivers differentiated medicines of value that will save, extend, and improve the lives of cancer patients.

Responsibilities:

  • Build a fit-for-purpose, nimble, and high performing clinical development organization that adeptly scales with company growth through strategic expansion of in-house capabilities and utilization of external resources
  • Support and lead change management initiatives that drive Candel’s successful growth and build on its existing strengths, culture and expertise
  • Ensure outstanding execution and delivery of in-flight studies central to Candel’s strategic imperatives
  • Be a core contributor to the overarching portfolio development strategy, with accountability for aligned asset, disease, and study level strategy
  • Establish and deliver integrated clinical development plans and data packages that enable efficient go/no-go decisions and seamless progression to registration studies and submissions
  • In collaboration with clinical development matrix team, responsible for study design, protocol writing, setup, oversight, and analysis of Phase 3 clinical trials
  • Ensure scientific integrity, accuracy, adherence to ICH-GCP and regulatory requirements
  • Provide clinical resource for design and interpretation of preclinical or clinical programs to support new development opportunities, including indication expansion/ lifecycle management, new therapeutic candidates, and due diligences
  • Champion integration of value-added translational and exploratory endpoints in clinical programs to provide novel insights to the development strategy
  • Provide oversight and key contributions to scientific communications, including manuscripts, abstracts, and presentations for scientific meetings
  • Engage and harness expertise internally and externally (e.g., KOLs) to support robust scientific dialogue, generate insights, and optimize development plans and strategies

Requirements:

  • MD is required
  • At least 10 years clinical development experience, including substantial oncology development experience with 5-10 years’ experience in the pharmaceutical industry preferably with late-stage development experience
  • Experience in a small company is preferred
  • Demonstrated outstanding leadership of multiple development projects and matrix teams, including ability to work effectively with internal and external clinical and scientific leaders
  • Experience leading or playing a substantial role in the design, conduct, analysis, and reporting of clinical studies, including experience submitting INDs/NDAs/BLAs to regulatory authorities
  • Deep experience in all phases of product development, especially in late phase development, clinical trial management, post approval studies, regulatory and manufacturing compliance
  • Understanding the entirety of R&D across the development/commercial life cycle to impact all line functions: discovery, late-stage development, regulatory, manufacturing, and commercial
  • Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions
  • Highly developed ethics and integrity, with demonstrated ethical decision-making skills
  • Strong interpersonal, influencing, presentation, and written and verbal communications skills; able to effectively address all levels within an organization and externally
  • Willingness and ability to travel

Interested candidates please submit your resume to careers@candeltx.com