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Associate Vice President / Director of Clinical Development

Cambridge, MA

Posted: 10/07/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2455

Job Description


Our client is looking for an Associate VP/Director of Clinical Development to contribute to defining clinical development objectives and clinical development plans. Reporting to the VP/SVP, Clinical Development, this person will be responsible for oversight of development and execution of studies linked to global clinical development plans for assigned programs. S/he will be responsible for integrating clinical development objectives with strategic business decisions, and ensures clinical, operational and medical governance excellence across all clinical development projects for assigned programs.

Responsibilities:
  • Lead the delivery of clinical development activities for identified clinical stage program(s) and ensure consistency with clinical development strategy
  • Lead cross-functional matrix team and be a major contributor to integrated clinical development strategy and Clinical Development Plans.
  • Assures clinical studies are conducted effectively in partnership with all relevant stakeholders (e.g. Clinical Operations colleagues and CRO as appropriate)
  • Lead clinical study teams in development and conduct of clinical studies.
  • Participate in data review discussions and contribute to data interpretation
  • Provide clinical inputs to the preparation of regulatory briefing documents and regulatory submission documents (IND, CTA, NDA, BLA, MAA)
  • Assist with the writing of manuscripts and development of abstracts and presentation materials.
  • This role will also contribute project level activities, as appropriate. This includes
  • responsibility and accountability for the coordination, execution and delivery of one or more portfolios of studies and programs.

Requirements/Qualifications:
  • MD or equivalent
  • 5+ years of experience in the pharmaceutical industry
  • A leader who is a passionate drug developer driven to help patients
  • Experience in clinical program management, clinical development strategy and study design/trial management and reporting is a must
  • Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
  • Proven track record in leading cross-functional teams and ability to be an effective leader of global teams.
  • Excellent verbal and written communication skills are a must.

Preferred qualifications:
  • Oncology or fibrosis experience is highly preferred
  • Experience with major regulatory submissions (IND, NDA, BLA, MAA)
  • Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise
  • Ability to interpret complex clinical data
  • Demonstrated excellence in stakeholder management. This role requires strategic thinking, solution finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change 
  • Demonstrated skills in networking internally and externally and communicating in situations requiring special tact and diplomacy
  • Possesses sound operational knowledge of the pharmaceutical industry and broader R&D processes including scientific activity impacting project work.
  • Demonstrates a proven ability to both independently complete and lead peers in completion in components of complex plans, i.e. draft protocols, selecting appropriate methodologies, measures, analytical plans and evaluation tools

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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