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Director, Clinical Development (Infectious Disease (RSV))

Cambridge, MA 02139

Posted: 02/09/2021 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2754

Job Description


Our client is seeking a board-certified physician to lead Clinical Development for one or more of their vaccine development programs in Infectious Diseases. Board certification in Infectious Diseases and/or Internal Medicine and experience in women’ s health is desirable. Industry experience in vaccine development is a plus.

This role will report to the Vice President of Clinical Development, Infectious Diseases, and will be the primary point person for the medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review of and contribution to interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners. The position is based at client headquarters in Cambridge, MA.

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines. Excellence in communication, teamwork, and collaboration is a must.

Responsibilities:
  • Provide medical leadership for individual programs at the trial and project team level.
  • Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
  • Provide medical safety oversight of CRO medical monitors.
  • Collaborate with pharmacovigilance in the analysis of clinical trial safety data.
  • Collaborate closely with clinical operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
  • Lead the design and writing of clinical protocols and associated clinical documents.
  • Lead the writing of clinical and safety sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
  • Collaborate closely with the CRO medical monitor for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
  • Assume primary responsibility for the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
  • Contribute to the writing of manuscripts and publications.
  • Assume primary responsibility for compliance with SOPs and adherence to ICH, GCP, and regulatory guidelines by the Clinical Team.
  • Provide medical leadership for internal audits and regulatory inspections.
  • Assist in preparations of materials for Advisory Board meetings.
  • Develop and maintain strong, collaborative relationships with the broader organization.
  • Represent client externally to trial site Investigators and administrators.

Requirements / Qualifications:
  • MD or non-US equivalent of MD degree with completion of residency in Internal Medicine, Family Practice, or Obstetrics/Gynecology. Completion of a fellowship or focused training in Infectious Diseases is desirable.
  • Minimum 3 years’ experience in early- to late-stage development in an academic or industry setting. Proven ability to plan and conduct clinical trial, and deliver high-quality results within established timelines.
  • Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
  • Ability to thrive in a fast-paced environment.
  • Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
  • Excellent analytical, problem-solving and strategic planning skills.
  • Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
  • Exceptional communication skills to meet the needs of varied audiences.
  • Outstanding writing skills.
  • Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.

Meet Your Recruiter

Aaron Goldman
Principal Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past nine 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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