Senior Medical Director
Company: Tocagen Inc.
Location: San Diego
Posted on: April 17, 2019
The Senior Medical Director will provide input to the development
plan and will be responsible for execution of portions of the
development plan including medical guidance during study design,
conduct and analysis. The Medical Director will play an active role
in the initiation of new investigational sites and ensure protocol
adherence. In addition to study level activities, the Medical
Director participates on study management teams, standing
committees such as the drug safety committee, review compounds for
potential in-licensing, provide assistance to new business
development opportunities, and provide input to the target product
profile and draft label. The Medical Director will generally
provide clinical support across multiple programs including pre-IND
development planning and Phase I, Phase II, or Phase III studies;
will also oversee clinical trials to ensure compliance with GCP
regulations and the safety of enrolled subjects. The Medical
Director is 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
Director works closely with the translational research group to
ensure translational, viral testing and immune function endpoints
are met, and is an integral member of the BLA submission
team.Duties and Responsibilities Include But Are Not Limited To:
- Provides strategic input into clinical development plan(s) and
leverage cross-functional expertise, such as preclinical support,
- Designs protocol strategy and assists with the development of
regulatory and study documents:
- Designs a clinical study to meet the agreed strategic
- Leads study teams in writing the synopsis and background
section of the protocol.
- Finalizes protocols and amendments.
- Approves study template informed consent form (ICF).
- Coordinates with the study team to review and approve study
processes and deliverables.
- Participates in the development of CRF, statistical analysis
plan (SAP), DMC charter and other documents as required by the
- Responsible for study conduct in conjunction with clinical
- Participates in study management team meetings, Data Monitoring
Committee (DMC) and steering committees as required.
- Answers safety questions and reviews the literature as needed;
provides input to safety issues and answers questions posed by IRB,
IBC, DMC, etc.
- Actively interacts with investigative sites, responds to
- Provides communication(s) to sites across the study.
- Assists sites with subject evaluation and protocol
- Reviews safety reports to support regulatory notifications and
- Participates in vendor selection for IRB, DMC and other
- Study Level Data Review:
- Performs review of data generated by data listings or
- Requests additional tables or analyses where appropriate.
- Reviews individual data with SAEs and potentially clinically
important laboratory test or vital sign abnormalities.
- Participates in all reviews and procedures required for
- Reviews all patient narratives.
- Reviews outstanding medical or GCP issues report and address
issues across the study.
- Provides input into the SAP and collaborate with biostatistics
team on statistical interpretation of data.
- Program level data review:
- Participates in the review of pooled study data for trends
across individual studies.
- Provide study team with medical expertise during key
- Responds to IRB/IEC/IBC with regard to medical, safety, ICF or
- Answers medical and inclusion/exclusion questions.
- Issues resolution.
- Audits response.
- Study closeout /inspection readiness.
- Oversees and conducts protocol training; produces relevant
- Delivers protocol training during Investigator meeting and Site
Initiation Visit (SIVs).
- Creates medical training materials for SIVs and study team
- Provides specific medical/protocol training for Clinical
Research Associates and study team.
- Develops medical/protocol training for use during Site
Initiation Visit (SIV).
- Answers questions specific to the protocol during the site
- Participates and/or leads, as appropriate, Pharmacovigilance
Activities, including safety evaluation and support for Tocagen
- In conjunction with the Tocagen drug safety team, answer
medical/safety questions and resolve medical/safety issues from
sites, CRAs and study team.
- In conjunction with other medical personnel, ensures answers
are consistent across all sites and studies.
- Participates or leads safety issue workups.
- Reviews study and individual subject safety for assigned
studies and present findings at quarterly drug safety reviews.
- Interacts 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.
- Supports regulatory update and interact with Health
- Assists with rest of world regulatory activities to support
study conduct and future marketing approval strategy and
- Contributes to, reviews, and edits Clinical Study Reports
- Approves patient narratives.
- Conducts decision point preparation for senior management.
- Contributes to IB updates for the project
- Develops or 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 the oversight of other BLA requirements such as
clinical pharmacology requirements for Toca FC and in response to
- Assists with advisory board activities.
- As needed, manages vendors (such as Pharmacovigilance vendor)
and manage consultants (such as Pharmacology, Clinical
Pharmacokinetic experts, etc.).
- Supports business development activities and interactions with
- Builds relationships and scientific outreach within the
oncology specialty community.
- Participates in cross-functional teams for the evaluation of
new development ideas, clinical development strategies and business
- In a highly matrixed organization, provides cross-functional
leadership support and mentoring.
- Manages direct reports as appropriate.
- Performs other duties as required.Desired Knowledge and
- Excellent communication skills; team member that can work
collaboratively with colleagues across all functions and at all
- Excellent analytical, presentation, writing, and computer
skills are required
- Strong scientific background and translation knowledge is an
- 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
- 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 neededEducation and Experience:
- Must possess an MD.
- Minimum of 2 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 oncology
or neurosurgery or radiation oncology at an academic level could
replace the requirement above.
- This is an onsite position.1
Keywords: Tocagen Inc., San Diego , Senior Medical Director, Executive , San Diego, California
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