SENIOR MEDICAL DIRECTOR

3 weeks ago

MA United States Clinical Dynamix, Inc. Full time
Responsibilities:

  • Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.
  • Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.
  • Drives clinical strategy and leads efforts to generate clinical development plans and target product profiles.
  • Designs and develops clinical study protocols and associated clinical study documents and contributes to program level documents such as Investigator Brochures.
  • Drives clinical trial execution to achieve timely completion of studies in collaboration with clinical teams.
  • Assumes medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
  • Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
  • Collaborates with senior colleagues to respond to health authority and ethics committee queries.
  • Collaborates with Principal Investigators in the evaluation and assessment and presentation of publications (abstracts, posters, manuscripts) associated with clinical data.
  • Participates in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data.
  • Performs functions in compliance with GCP, and good medical practice.
  • Networks extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the company's vision.

Qualifications:

  • Medical degree (or equivalent).
  • Board certification/eligibility and clinical experience in I/I through phase 3 highly preferred.
  • 8+ years of clinical development experience within the pharmaceutical or biotechnology industry with a focus and strong track record of experience leading clinical trials.
  • Strong working knowledge of the clinical drug development process required.
  • Must have a solid understanding of the relevant clinical landscape and health care practitioners in the field.
  • Requires a track record in the conduct of/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
  • Requires strong credibility within the US medical community including the ability to reach out to key thought leaders in academia.
  • The demonstrated ability to work in a matrix environment with cross-functional teams is required.

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