Senior Medical Director

San Diego, CA
Mar 08, 2019
Required Education
Associate Degree
Position Type
Full time
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, as required.
  • Designs protocol strategy and assists with the development of regulatory and study documents:
    • Designs a clinical study to meet the agreed strategic context.
    • 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 study.
  • Responsible for study conduct in conjunction with clinical operations:
    • 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 protocol/medical questions.
    • Provides communication(s) to sites across the study.
    • Assists sites with subject evaluation and protocol adherence.
    • Reviews safety reports to support regulatory notifications and filings.
    • Participates in vendor selection for IRB, DMC and other outsourcing activities.
  • Study Level Data Review:
    • Performs review of data generated by data listings or statistical analyses.
    • 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 database lock.
    • 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 activities:
    • Responds to IRB/IEC/IBC with regard to medical, safety, ICF or protocol issues.
    • Answers medical and inclusion/exclusion questions.
    • Issues resolution.
    • Audits response.
    • Study closeout /inspection readiness.
  • Oversees and conducts protocol training; produces relevant materials:
    • Delivers protocol training during Investigator meeting and Site Initiation Visit (SIVs).
    • Creates medical training materials for SIVs and study team training.
    • 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 start-up process.
  • Participates and/or leads, as appropriate, Pharmacovigilance Activities, including 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.
    • 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 Authorities.
    • Assists with rest of world regulatory activities to support study conduct and future marketing approval strategy and execution.
  • Contributes to, reviews, and edits Clinical Study Reports (CSR):
    • 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 FDA queries.
  • 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 corporate partners.
  • 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 development assessments.
  • 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 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 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.