Reports To: Chief Medical Officer
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
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.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Head of Clinical Development will provide strategic direction and technical leadership to the clinical development group and is responsible for the overall management and performance of department functions from Phase I-IV for drug products, including: clinical trial design, implementation and execution, clinical research, data analysis and management. The Head of Clinical Development is responsible for overseeing clinical development, pharmacovigilance, and biostatistics according to agreed-upon deadlines and budgets. Working closely with the CMO, the Clinical Development/Pharmacovigilance/Biostatistics group(s), R&D, Regulatory, Medical Affairs and the Commercial Development teams, the Head of Clinical Development will develop and execute regulatory and Phase I-IV clinical trial strategy and design. The Head of Clinical Development is responsible for the management of the Clinical Development department.
Duties and Responsibilities Include But Are Not Limited To:
- Responsible for preparing clinical portions of new Drug Applications and Biologics License Applications, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.
- Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings.
- Establish and maintain relationships with alliance partners, external companies (such as CRO), investigators and opinion leaders to optimize performance on clinical trial activities.
- Prepare manuscripts for technical journals and make presentations at scientific meetings.
- Work collaboratively with Research and Development providing input into design of preclinical trials to support drug products entering or in the clinic and by helping initiate Investigational New Drug Applications
- Provides input to evaluate products for in licensing/out licensing.
- Participate in business development processes as needed.
- Accountable for clinical portion of regulatory documents such as Investigator Brochure update, and Drug Safety Update Reports.
- Manage and be responsible for pharmacovigilance for clinical projects including review and reporting of SAEs with support from pharmacovigilance providers as available.
- Performs other duties as required.
- Appendix A: Accountable for medical monitor activities for Phase I-IV studies through direct execution of activities or supervision of a medical monitor dependent on current staffing.
Desired Knowledge and Abilities:
- Exemplify Tocagen’s guiding principles of building strong teams, leading with inspiration, making data driven decisions, and maintaining focus,
- Critical, creative and deep thinker.
- Demonstrated ability to think strategically and successfully operationalize ideas and visions
- Excellent communications skills; team member that can work collaboratively and extremely well with colleagues across all functions and levels.
- High level of personal integrity, high moral character, excellent work ethics and respect for colleagues at all levels, and empathy.
- Demonstrated track record as a solid, thoughtful leader with exceptional interpersonal skills.
- Excellent manager with a desire to help with career development of individuals on cross-functional teams
- Demonstrated experience of FDA/EMEA/Japan PMDA requirements, good clinical practices and pharmaceutical clinical development in oncology.
- Demonstrated experience leading to drug approval
- Must have leadership experience in a high growth environment and the ability to delegate tasks as appropriate.
- Ability to build on solid relationships with the NCI, NIH and other agencies including European collaborative groups and to forge strong internal and external partnerships.
- Excellent analytical and strategic planning skills, with a track record of recruiting and/or out-sourcing high-performing clinical teams.
- Proven organizational and project management skills and ability to handle multiple diverse projects simultaneously.
- Ability to maintain a problem-solving attitude in response to time demands and unexpected events.
- Capable of supporting multiple projects simultaneously.
- Ability to succeed in a deadline-driven environment.
- Work proactively and effectively in a fast-paced environment.
- Ability to work accurately with close attention to detail.
- Ability to adapt to changes in company structure and responsibilities.
- Ability to travel domestically and internationally.
Education & Experience:
- MD required in a relevant scientific discipline.
- Minimum of approximately 6 years’ experience in relevant industry experience in clinical/medical research or pharmaceuticals/devices.
- Minimum 4+ years of supervisory experience managing a clinical functional team.
- Oncology experience required.
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 and execution. In addition to study level activities, they participate on study management teams, standing committees such as the drug safety committee, review compounds for potential in-licensing, and provide assistance to new business development on market opportunity and target product profile. Generally provides clinical support across multiple programs including pre-IND development planning and Phase I, Phase II, or Phase III studies; they oversee clinical trials to ensure compliance with GCP regulations and the safety of enrolled subjects. They may also be required to participate in design development strategy for drug products with multiple protocols designed to obtain world-wide approval. Plays an active role in the initiation of new investigational sites; may observe surgical procedures/interventional procedures. Monitor protocol conduct to ensure protocol adherence.
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.
- Approve 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 and know the relevant 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 from sites.
- Provide communication(s) to sites across the study.
- Assist sites with patient 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.
- Understanding the study results to enable data driven decisions
- Provide Study Team with medical expertise during key activities.
- 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.
- 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 protocol.
- Answer medical and inclusion/exclusion questions.
- Ensure answers are consistent across all sites and studies.
- 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 and registration submissions.
- 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 and lead development of scientific meeting abstracts and presentations as well as manuscripts.
- Performs other duties as required.