Reports To: Senior Director, Project Manager and Team Leader
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 Project Manager will be responsible for ensuring the scope and direction of programs through all stages of the candidate development process, including both Phase 1-3 clinical development studies. This position will be able to develop and manage detailed project plans, drive the matrix project teams to achievement of key milestones, and facilitate communication throughout all levels of the organization. In addition, the Project Manager may play a leadership role in the future development of new programs such as investigator-sponsored trials (IST), compassionate use and named patient protocols.
Duties and Responsibilities Include But Are Not Limited To:
- Develops a detailed project plan and monitors timelines and key milestones for clinical programs.
- Manages day to day project activities for the BLA Submission Team.
- Facilitates communication through the organization.
- Provides support for new assets transitioning from research to the clinic.
- Performs other duties as required.
Desired Knowledge and Abilities:
- A strong track record of leading teams to evaluate new therapies in the pharmaceutical industry (cancer or gene therapy experience preferred).
- Technical experience in a discipline associated with drug development.
- Knowledge of issues that drive early and late stage development projects.
- Previous experience with delivery of an NDA or BLA.
- Excellent written and verbal communication skills
- Strong organizational, analytical, interpersonal, and time management skills.
- Networking/alliance building/experience
- Ability to drive consensus and decision making.
- Must be able to prioritize and work effectively in a constantly changing environment.
- Basic knowledge of regulatory requirements for clinical/medical activities for the U.S., Canada and ROW
Education & Experience:
- An Advanced Degree (PhD, MS) or equivalent experience in a relevant scientific and/or Project Management discipline is required; PMP certification is a plus.
- Minimum of 8+ years relevant experience in drug development pharmaceutical/biotechnology experience.
- Experience with biological products or cancer immunotherapeutics an asset, but not required
- General understanding of the FDA, EMA, ICH and other guidelines relevant to the pharmaceutical industry.
- Proficiency in Microsoft Office suite applications and proficiency in Microsoft Project