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Sr. Medical Director/ VP- Clinical Development

  • Location Cambridge
  • Job-type Permanent
  • Reference BBBH100285

The Vice President, Clinical Development will be accountable for leading clinical development for assigned programs of product portfolio from early development, through Phase 2.

The VP will work closely and collaboratively with other senior and functional leaders to ensure fully harmonized and integrated development strategies, and to drive portfolio prioritization.

Key Responsibilities

  • Develop and manage product profiles and Clinical Development Plans; lead the design, development and implementation of innovative clinical trials for novel drug candidates and biosimilars, from translational stage through global Phase 2 trials and registration.
  • Lead Clinical Development efforts with aggressive, creative but realistic approaches to drug development across multiple therapeutic areas and product modalities
  • Apply state-of-the-art knowledge of disease mechanisms to selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations to support innovative clinical study designs for novel products.
  • Maintain the highest quality clinical programs, following GCP and ICH guidelines. Manage timely reporting of safety signal to regulatory authorities and the generation of clinical study reports.
  • Communicate regularly and effectively with senior leaders across the R&D organization
  • Lead clinical team to secure global regulatory approvals for pipeline products

Qualifications

  • MD with 7+ years of industry experience
  • Experience in clinical rare diseases or oncology
  • Proven track record of successful drug development; experience with Phase 1 through Phase 3 trials
  • Excellent communication and leadership skills; willingness to "roll up the sleeves" to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
  • Shows fresh, insightful thinking by developing creative approaches to processes and practices, products & solutions, services, business models & strategy

Job Type: Full-time