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Vice President, Clinical Development

Cambridge, MA

Posted: 12/09/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2351

Job Description

Our Client is looking to add a senior leader to their clinical team who has experience in successfully leading people and clinical programs in the oncology space.

  • Provide clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program including individual protocols, clinical communication and publications.  Ownership of design, interpretation and reporting of clinical data.
  • Assist ClinOps in operational aspects of program including site selection, project related training and education of investigators, trial conduct and timely execution of assigned clinical deliverables within approved budget.
  • Support the CMO in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders.
  • Partner with the CMO in ensuring overall safety of the compound including safety of patients in clinical studies and detection of safety signals.
  • Lead development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
  • Generate clinical development plans and provide strategic direction for clinical and preclinical assets.
  • Present program data and medical strategies to a wide variety of audiences including internal teams and external stakeholders (e.g. advisory boards)
  • Act as medical subject matter expert in project teams

  • MD required.
  • 10+ years of experience in clinical research or drug development in an industry setting spanning clinical activities in multiple Phases of clinical trials.
  • Medical/scientific and operational expertise in oncology and/or hematology.
  • Years of demonstrated leadership and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing).
  • Strong leadership, management, interpersonal, communication, and problem solving skills.
  • Strong negotiation and diplomatic skills, experience with health authorities desirable.
  • Demonstrated technical knowledge and innovation in clinical development study designs that provide relevant evidence to decision-makers.
  • Knowledge and understanding of GCP and ICH guidelines
  • Some travel required.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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