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 Barrington James
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