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VP Late Stage Development Leader Clinical Development

  • Needham, MA
  • Direct Hire
  • Job ID: BN38-2690864

$1 to $2 Per Year

VP Development Leader,

VP Development Leader (late stage) is a critical leadership role within company, reporting to the Chief Medical Officer (CMO) and working closely with the Leadership Team 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.

Key accountabilities and 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 company's successful growth and build on its existing strengths, culture and expertise
  • Ensure outstanding execution and delivery of in-flight studies central to company’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

 

Qualifications

MD, PhD, Pharm D or equivalent

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

 

 

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