Reports To: Senior Vice President and Chief Medical Officer
Position Type: Contract position
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
The Medical Monitor provides input to the development plan and is responsible for execution of portions of the development plan including medical guidance during study design, conduct and analysis. The Medical Monitor plays an active role in the initiation of new investigational sites and ensures protocol adherence. In addition to study level activities, he/she participates on study management teams, standing committees such as the drug safety committee, reviews compounds for potential in-licensing, and provides assistance to new business development opportunities and provides input to the target product profile and draft label. Generally provides clinical support across multiple programs including pre-IND development planning and Phase I, Phase II, or Phase III studies; he/she oversees clinical trials to ensure compliance with GCP regulations and the safety of enrolled subjects. He/she may also be required to participate in design development strategy for a compound or group of compounds with multiple protocols designed to obtain world-wide approval. In addition the medical monitor works closely with the translational research group to ensure translational, viral testing and immune function endpoints are met. Finally is an integral member of the BLA submission team.
Duties and Responsibilities Include But Are Not Limited To:
- Design protocol strategy and assist with development of regulatory and study documents
- Design a clinical study to meet the agreed strategic context.
- Leads study team in writing the synopsis and background section of the protocol.
- Finalize protocols and amendments.
- Approve study template informed consent form (ICF).
- Coordinate with the study team to review and approve study processes and deliverables.
- Participates in development of CRF, statistical analysis plan (SAP), DMC charter and other documents as required by the study.
- Responsible for study conduct in conjunction with clinical operations
- Participate in study management team meetings, Data Monitoring Committee (DMC) and steering committees as required.
- Answer safety questions and review the literature as needed; provide input to safety issues and answer questions posed by IRB, IBC, DMC, etc.
- Actively interact with investigative sites, respond to protocol/medical questions
- Provide communication(s) to sites across the study.
- Assist sites with subject evaluation and protocol adherence.
- Review safety reports to support regulatory notifications and filings.
- Participate in vendor selection for IRB, DMC and other outsourcing activities.
- Study Level Data Review
- Perform review of data generated by data listings or statistical analyses.
- Request additional tables or analyses where appropriate.
- Review individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities.
- Participate in all reviews and procedures required for database lock.
- Review all patient narratives.
- Review outstanding medical or GCP issues report and address issues across the study.
- Provide Study Team with medical expertise during key activities
- Answer medical and inclusion/exclusion questions
- Issue resolution.
- Audit response.
- Study closeout / inspection readiness.
- Oversee and conduct protocol training; produce relevant and materials
- Deliver protocol training during Investigator meeting and Site Initiation Visit (SIVs).
- Create medical training materials for SIVs and study team training.
- Provide specific medical/ protocol training for Clinical Research Associates (CRAs) and study team.
- Develop medical/ protocol training for use during Site Initiation Visit (SIV).
- Be available to answer questions specific to the protocol during the site start-up process.
- Participate in safety evaluation and support for Tocagen products
- In conjunction with the Tocagen drug safety team, answer medical/safety questions and resolve medical/safety issues from sites, CRAs and study team; such as questions from sites on protocols. In conjunction with other medical personnel, ensure answers are consistent across all sites and studies.
- Participate or lead safety issue workups
- Review study and individual subject safety for assigned studies and present findings at quarterly drug safety reviews.
- Interact with regulatory groups and internal auditing groups on a study level
- DMC Interaction.
- Accountable for providing a response to regulatory agency inspection observations and internal audits.
- Support regulatory update
- Assists with rest of world regulatory activities to support study conduct and future marketing approval strategy and execution
- Contribute to, review, and edit Clinical Study Reports (CSR)
- Approve patient narratives.
- Conduct decision point preparation for senior management.
- Contributes to IB updates for the project
- Assists in development of scientific meeting abstracts and presentations as well as manuscripts
- BLA submission team
- Member of the team with specific responsibilities including CSR as well as summary documents which may be assigned
- Assists in oversight of other BLA requirements such as clinical pharmacology requirements for Toca FC
- Performs other duties as required.
Desired Knowledge and Abilities:
- Excellent communication skills; team member that can work collaboratively with colleagues across all functions and at all levels
- Excellent analytical, presentation, writing, and computer skills are required
- Strong scientific background and translation knowledge is an asset
- Ability to maintain a problem-solving attitude in response to time demands and unexpected events
- Demonstrated track record as a solid, thoughtful leader with exceptional interpersonal skills
- Working knowledge of FDA and global processes
- Well versed in GCP requirements.
- Provide administrative leadership and knowledge-based expertise in related areas that can be applied to meeting the strategic goals
- Ability to work well in a deadline-driven environment
- Drives for results
- Ability to work in a cross-functional team
- Capable of supporting multiple projects simultaneously
- Travel as needed
Education & Experience:
- Must possess an MD.
- Minimum of 5 years of clinical research experience in an established CRO, or major pharmaceutical organization/biotech in clinical trials performed according to GCP requirements and intended for submission to regulatory agencies is required.
- Clinical training and at least 2 years’ experience in neuro-oncology or neurosurgery or radiation oncology at an academic level could replace the requirement above.