Director, Medical Safety Monitor
The Medical Safety Monitor is responsible for serving as the medical monitor for clinical trials products throughout their lifecycle; ensuring medical safety data review and evaluation in accordance with post-market and pre-market regulatory requirements. The individual will, when appropriate, as a result of their medical experience, contribute to clinical development and medical affairs activities as part of the broader team. A successful candidate will be familiar with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.
Essential Duties & Responsibilities
- Review clinical protocols, study reports, clinical trial supporting materials, and other related documents.
- Engage with clinical team to answer eligibility and other medical related questions associated with clinical trials.
- Provide therapeutic area training.
- Author Medical Monitoring Plan for each clinical trial.
- Establish and manage all safety-related processes.
- Contribute to regulatory submissions including authoring relevant sections of the submissions.
- Author, review, and provide input for drug-safety related regulatory reports and clinical study documents.
- Contribute to the development of internal processes including SOPs, guidelines, and Work Instructions.
- Act as medical and scientific subject matter expert for expansion of the team’s pharmacovigilance capabilities
- Review clinical safety databases, creating narrative reports for notable clinical events
- Assists sites with subject evaluation and protocol adherence and preparing safety reports to support regulatory notifications and filings
- Serve as the main liaison between the different bodies involved in the safety process i.e. between the DSMB, CEC, CRO, investigators and study team
- Assists in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials
- Develop, coordinates and completes clinical study safety training for all staff involved with clinical study
- Interfaces with internal and external multi-disciplinary teams/committees in regards to the activities of the clinical trial(s)
- MD with 2+ years relevant experience (including academia)
- PhD with 5+ years strong oncology clinical development industry experience that includes clinical development planning, clinical trial design and execution, regulatory filings and exposure to commercial and payer aspects of drug development
- Accredited residency training and board-certification/eligibility in oncology or internal medicine evolving datasets and information
- Demonstrated expertise in efficacy and safety data interpretation and communication
- Basic understanding of biostatistics methodology
- Demonstrated understanding of scientific methodology and applications within clinical development
- Demonstrated understanding of clinical development planning that includes scientific, regulatory, commercial and reimbursement aspects
- Must be comfortable in assessing complex problems and synthesizing solutions based on evolving datasets and information
- Ability to effectively communicate complex scientific concepts to broader audience
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
- Ability to influence and drive a cross functional team
- Experience with NDA/BLA highly desirable
- Willingness to travel
- Ability to represent the program and engage external business partners /KOLs /regulatory bodies
- Self-motivated, with initiative and the ability to take ownership of and follow through with specific tasks within timelines and budgets
- Ability to multi-task, shift priorities quickly and work in high paced start up environment
- Must have excellent interpersonal, written and verbal communication skills.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Email resumes to firstname.lastname@example.org. Please reference Job ID: Director, Medical Safety Monitor
Apexigen is an equal opportunity employer