Medical Director III – AML Clinical Trial Medical Monitoring

Medical Director III – AML Clinical Trial Medical Monitoring
Position Title: Medical Monitor / Director
Location: Remote — Candidates must be located in the United States and able to work without visa sponsorship.
Length of Assignment: 6 months
Pay Rate: $165-180/hr (depending on benefits preference and candidate location)
 
Job Description:
 
The Medical Director III will serve as an independent Medical Monitor supporting clinical development programs in acute myeloid leukemia (AML). Under appropriate supervision, this individual will manage the design, implementation, oversight, and evaluation of clinical study protocols in alignment with the overall Product Development Plan.
 
The Medical Director will apply sound medical and scientific judgment, knowledge of regulatory and compliance requirements, and awareness of customers, markets, business operations, and emerging issues.
 
Key responsibilities include:

• Provide medical oversight of clinical studies, including monitoring overall study integrity and reviewing, interpreting, and communicating accumulating safety and efficacy data.
• Independently and thoroughly review safety data, identify emerging risks, and escalate issues appropriately.
• Partner with Clinical Operations to oversee study enrollment, timelines, and key deliverables.
• Assess and report serious adverse events in accordance with corporate policies and applicable regulations for assigned protocols.
• Provide study-related education, training, and guidance to investigators, study-site personnel, study staff, and clinical staff.
• Maintain current expertise in hematology, AML, and related therapeutic developments through medical literature, professional education, and familiarity with relevant technologies.
• Ensure compliance with Good Clinical Practice, pharmacovigilance standards, standard operating procedures, and all applicable quality and safety requirements.
• Demonstrate the highest standards of medical ethics and seek appropriate consultation when patient-care concerns or protocol-related questions fall outside the individual’s scope of practice or expertise.
• Collaborate with cross-functional partners across Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, Quality Assurance, and other matrixed teams.
• Communicate scientific, clinical, safety, and operational findings clearly to internal and external stakeholders.
• Participate in quality assurance and continuous-improvement activities, including clinical audits, peer reviews, and regularly scheduled review meetings.
• Advise and update the Executive Director regarding relevant clinical and operational matters.
• Contribute to training and knowledge sharing within the Clinical Development organization, including clinical monitoring practices, procedures, data quality, actionable data interpretation, and workflow integration.
• Attend staff, committee, board, and other meetings as required to represent the department or organization.
• Work effectively with global study sites and cross-functional partners across multiple time zones.

 
Qualifications:
 
I. Required qualifications:

• Medical Doctor (M.D.), Doctor of Osteopathic Medicine (D.O.), or equivalent non-U.S. medical degree.
• Medical specialization and relevant clinical experience in hematology.
• At least five years of relevant experience in an academic, hospital, pharmaceutical, or equivalent clinical-research setting.
• Ability to function as an independent Medical Monitor.
• Previous clinical-trial experience involving acute myeloid leukemia.
• Ability to independently and thoroughly review emerging safety and efficacy data, proactively identify risks, ensure accurate data entry, and escalate issues appropriately.
• Proven ability to collaborate effectively with cross-functional teams.
• Excellent written and verbal communication skills in English.
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced, matrixed environment.
• Familiarity with Good Clinical Practice, pharmacovigilance principles, clinical-research compliance requirements, and applicable regulatory standards.

 
II. Preferred qualifications:

• U.S. residency training is strongly preferred.
• Completion of a relevant subspecialty fellowship is desirable.
• Acute leukemia clinical experience and/or experience supporting AML clinical trials.
• Clinical-trial experience in the pharmaceutical industry, academia, or an equivalent setting.
• Medical monitoring experience involving immunotherapies and antibody-drug conjugates (ADCs).
• Knowledge of clinical-trial methodology, study oversight, medical monitoring, and the regulatory and compliance requirements governing clinical research.
• Ability to support global sites and collaborate across multiple time zones.

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