Director Medical Monitoring
Director Medical Monitoring
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
- 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 collaborating with crossfunctional teams to advance clinical programs.
- Support site selection patient recruitment and investigator engagement through regular interactions and guidance.
- Lead or colead clinical study teams facilitating discussions and decisionmaking 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.
- 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 fastpaced environment.
- Willingness to travel up to 20 for clinical and regulatory engagements.
- Strategic thinking and problemsolving in clinical development.
- Strong interpersonal and crossfunctional 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.
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Required Experience:
Director
Employment Type
Full-Time
