Director, Medical Monitoring Job at Barrington James, New York, NY

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  • Barrington James
  • New York, NY

Job Description

Director, Medical Monitor (MD)

Location: New York, United States

Summary:

An experienced physician specializing in clinical development, providing strategic medical oversight and monitoring for innovative immuno-oncology programs. Expertise in leading clinical trial design, execution, and safety monitoring for early- and late-stage programs in oncology. Strong background in regulatory interactions, cross-functional leadership, and clinical trial operations.

Key Responsibilities:

  • Serve as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversight.
  • Address medical inquiries from investigators, regulatory agencies, and internal teams, ensuring consistent application of protocol guidelines.
  • Monitor clinical trial conduct, assessing safety data, adverse events (AEs), serious adverse events (SAEs), and emerging safety signals.
  • Provide medical expertise in study design, protocol development, and execution, collaborating with cross-functional teams to advance clinical programs.
  • Support site selection, patient recruitment, and investigator engagement through regular interactions and guidance.
  • Lead or co-lead clinical study teams, facilitating discussions and decision-making processes.
  • Participate in interactions with regulatory authorities, preparing clinical documentation and supporting regulatory submissions.
  • Collaborate with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical development objectives.
  • Develop and review essential study documents, including protocols, investigator brochures (IBs), informed consent forms (ICFs), data review plans, and clinical study reports (CSRs).
  • Contribute to internal governance processes and strategic development discussions.
  • Support publication planning and contribute to abstracts, posters, and manuscripts.

Qualifications & Experience:

  • Medical Degree (MD or equivalent) with a strong background in oncology and hematology.
  • 10+ years of experience in pharmaceutical/biotech clinical development or relevant clinical research roles.
  • At least 5 years of experience serving as a medical monitor for clinical trials.
  • Extensive knowledge of clinical trial safety monitoring, adverse event assessment, and regulatory requirements.
  • Familiarity with global regulatory frameworks, including FDA and EMA guidelines.
  • Strong ability to assess clinical data and provide medical judgment in complex situations.
  • Excellent communication and leadership skills, with the ability to work in a dynamic, fast-paced environment.
  • Willingness to travel up to 20% for clinical and regulatory engagements.

Core Competencies:

  • Strategic thinking and problem-solving in clinical development.
  • Strong interpersonal and cross-functional collaboration skills.
  • Ability to interpret and present clinical data effectively.
  • Expertise in regulatory interactions and clinical trial operations.
  • Adaptability in a biotech environment with a focus on innovation and efficiency.

#LI-OG1

Job Tags

Permanent employment,

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