Associate Medical Director / Medical Monitor - Remote Position
The Associate Medical Director / Medical Monitor, Clinical Sciences provides medical leadership for the design, execution, and oversight of clinical trials across one or more therapeutic areas within the oncology portfolio. This role is responsible for ensuring that clinical studies are scientifically rigorous, ethically conducted, operationally feasible, and compliant with global regulatory requirements.
The individual will serve as Associate Medical Director / Medical Monitor for ongoing studies and will collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Medicine, and other stakeholders to support successful development of investigational products across all phases of development. The role also contributes to scientific communications, regulatory interactions, lifecycle management activities, and external scientific engagement.
Major Duties / Responsibilities
Clinical Development and Study Leadership:
• Provide medical leadership for the design, conduct, and oversight of Phase I-IV clinical studies in oncology.
• Serve as Associate Medical Director / Medical Monitor for ongoing clinical trials, including:
• patient eligibility review,
• protocol deviation assessment,
• safety signal evaluation,
• dose modification guidance,
• and ongoing medical oversight throughout study conduct.
• Contribute to development strategy and study design, including endpoint selection, biomarker integration, and translational research components.
• Review and interpret clinical data, including efficacy, safety, PK/PD, biomarker, and translational datasets.
• Participate in data review meetings, safety review committees, dose escalation meetings, and advisory boards.
Patient Safety and Compliance:
• Ensure patient safety, data integrity, protocol compliance, and adherence to ICH-GCP and applicable regulatory requirements.
• Contribute to benefit-risk assessments and ongoing safety monitoring activities
Medical and Scientific Documentation:
• Author and review key clinical and regulatory documents including:
• clinical study protocols,
• investigator brochures,
• informed consent forms,
• clinical study reports,
• safety narratives,
• regulatory briefing documents,
• and responses to health authority queries.
• Support IND/CTA submissions and global regulatory interactions.
Cross-Functional Collaboration:
• Partner closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Medicine, and CMC teams to ensure scientifically sound and operationally executable study conduct.
• Provide medical/scientific input into investigator-initiated studies, medical information responses, and lifecycle management activities for approved products, as applicable.
• Support protocol training and ongoing scientific guidance for study teams and CRO partners.
External Scientific Engagement:
• Engage with investigators, study sites, CROs, and key opinion leaders to address scientific and medical questions.
• Represent the company at scientific congresses, advisory boards, investigator meetings, and external scientific forums.
• Support development of scientific communication strategies including:
• abstracts,
• manuscripts,
• publications,
• congress presentations,
• and educational materials.
Skills, Abilities and Competencies
• Clinical trial design and execution
• Clinical data review and interpretation
• Safety assessment and benefit-risk evaluation
• Strategic thinking and scientific leadership
• Strong written and verbal communication skills
• Ability to effectively communicate complex medical concepts to diverse audiences
• Cross-functional collaboration and decision-making in a fast-paced environment
• Ability to manage multiple priorities and shifting timelines
Required Education and Professional Experience
MD, DO, or equivalent medical degree
• 5-10+ years of experience in drug development, clinical research, clinical practice, academic medicine, translational research, or a combination thereof
• Strong understanding of clinical trial methodology, oncology drug development, and global regulatory requirements
• Knowledge of ICH-GCP and applicable FDA/EMA regulatory frameworks
• Excellent scientific communication and presentation skills
Preferred Education and Experience
• Prior experience as Associate Medical Director / Medical Monitor or Clinical Study Lead
• Experience in oncology clinical development, including breast cancer clinical research
• Experience with global and/or multicenter clinical trials
• Experience supporting regulatory submissions and health authority interactions
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working outside of these hours and may extend to evenings and weekends as business needs require.
Work Environment
This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.
Travel
The role requires infrequent travel. Minimal travel may be required for meetings and/or conferences, up to 5%.
Physical Demands
This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds.
Compensation Range
The salary range for this role is $210,000 - $225,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.
At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
#LI-Remote
The individual will serve as Associate Medical Director / Medical Monitor for ongoing studies and will collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Medicine, and other stakeholders to support successful development of investigational products across all phases of development. The role also contributes to scientific communications, regulatory interactions, lifecycle management activities, and external scientific engagement.
Major Duties / Responsibilities
Clinical Development and Study Leadership:
• Provide medical leadership for the design, conduct, and oversight of Phase I-IV clinical studies in oncology.
• Serve as Associate Medical Director / Medical Monitor for ongoing clinical trials, including:
• patient eligibility review,
• protocol deviation assessment,
• safety signal evaluation,
• dose modification guidance,
• and ongoing medical oversight throughout study conduct.
• Contribute to development strategy and study design, including endpoint selection, biomarker integration, and translational research components.
• Review and interpret clinical data, including efficacy, safety, PK/PD, biomarker, and translational datasets.
• Participate in data review meetings, safety review committees, dose escalation meetings, and advisory boards.
Patient Safety and Compliance:
• Ensure patient safety, data integrity, protocol compliance, and adherence to ICH-GCP and applicable regulatory requirements.
• Contribute to benefit-risk assessments and ongoing safety monitoring activities
Medical and Scientific Documentation:
• Author and review key clinical and regulatory documents including:
• clinical study protocols,
• investigator brochures,
• informed consent forms,
• clinical study reports,
• safety narratives,
• regulatory briefing documents,
• and responses to health authority queries.
• Support IND/CTA submissions and global regulatory interactions.
Cross-Functional Collaboration:
• Partner closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Medicine, and CMC teams to ensure scientifically sound and operationally executable study conduct.
• Provide medical/scientific input into investigator-initiated studies, medical information responses, and lifecycle management activities for approved products, as applicable.
• Support protocol training and ongoing scientific guidance for study teams and CRO partners.
External Scientific Engagement:
• Engage with investigators, study sites, CROs, and key opinion leaders to address scientific and medical questions.
• Represent the company at scientific congresses, advisory boards, investigator meetings, and external scientific forums.
• Support development of scientific communication strategies including:
• abstracts,
• manuscripts,
• publications,
• congress presentations,
• and educational materials.
Skills, Abilities and Competencies
• Clinical trial design and execution
• Clinical data review and interpretation
• Safety assessment and benefit-risk evaluation
• Strategic thinking and scientific leadership
• Strong written and verbal communication skills
• Ability to effectively communicate complex medical concepts to diverse audiences
• Cross-functional collaboration and decision-making in a fast-paced environment
• Ability to manage multiple priorities and shifting timelines
Required Education and Professional Experience
MD, DO, or equivalent medical degree
• 5-10+ years of experience in drug development, clinical research, clinical practice, academic medicine, translational research, or a combination thereof
• Strong understanding of clinical trial methodology, oncology drug development, and global regulatory requirements
• Knowledge of ICH-GCP and applicable FDA/EMA regulatory frameworks
• Excellent scientific communication and presentation skills
Preferred Education and Experience
• Prior experience as Associate Medical Director / Medical Monitor or Clinical Study Lead
• Experience in oncology clinical development, including breast cancer clinical research
• Experience with global and/or multicenter clinical trials
• Experience supporting regulatory submissions and health authority interactions
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working outside of these hours and may extend to evenings and weekends as business needs require.
Work Environment
This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.
Travel
The role requires infrequent travel. Minimal travel may be required for meetings and/or conferences, up to 5%.
Physical Demands
This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds.
Compensation Range
The salary range for this role is $210,000 - $225,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.
At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
#LI-Remote