Head of Clinical Operations
PACT Pharma is an exciting new company with laboratories in the San Francisco Bay Area. PACT is developing personalized adoptive T cell therapies for the eradication of solid tumors. The identification of neo-epitopes that serve as private mutations for each patient’s cancer creates a unique opportunity to engineer autologous T cells that target and kill tumors expressing these neo-antigens. PACT utilizes technology licensed from the laboratories of Drs. Heath and Baltimore (Caltech) to identify T cells that recognize the neo-epitope. The unique T-cell receptor (TCR) sequences obtained from these neoepitope-reactive cells are then engineered into T cells from the patient’s own blood to produce PACT’s therapeutic product: a tsunami of fresh, active T cells that, following infusion into the patient, recognize and attack each patient’s cancer cells.
We are located in the San Francisco bay area, in the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. PACT Pharma is an ambitious cutting-edge undertaking - we fully anticipate our company to become the world’s leader in personalized adoptive T cell therapies for cancer and therefore key to the future of cancer treatment. We are currently located in Hayward, CA, but will be moving our offices to South San Francisco by the end of the year.
Reports To: VP Clinical Development
The Sr. Director/Director, Clinical Operations leads clinical operations programs, providing vision, management, and daily execution. Program(s) goals, milestones and deliverables are achieved via a close interaction and collaboration with all functional lines involved in clinical development. Responsibilities include operational leadership and successful execution of clinical trials according to regulatory guidelines, oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables; oversight and continuous improvement of department infrastructure through the development of SOPs, guidelines and the use of technology; facilitation of effective internal and external relationships, and achievement of clinical project goals and objectives. The candidate should enjoy operating in an exceptionally dynamic and cooperative environment.
- BA/BS in related life sciences field with prior experience managing oncology trials. Advanced degree strongly preferred
- 10+ years of progressive clinical operations experience in pharmaceutical/drug development, with a preference for immunotherapy/biologics experience, and including 7 years of experience in clinical study management
- Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
- Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors.
- Expertise in the areas of drug development and global clinical operations
- Track record of leading a cross-functional team in a matrix environment
- Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done)
- Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
- Demonstrated, effective planning, including risk assessment, contingency planning and ability to prioritize.
- Experienced with submissions from investigational new drug through biologic license application filings.
- Willingness to travel domestically and internationally
- Prior experience in immuno-oncology, personalized medicine, T cell therapy a plus
- Prior experience in a hands-on early development role building out a department within a small organization a plus