Clinical Trial Manager
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.
The CTM is responsible for the management of all aspects of clinical study execution. The CTM in concert with the Director of Clinical Operations is accountable for achieving successful delivery of clinical trials from early concepts through final data lock and finalization of the Clinical Study Report (CSR). The CTM will proactively manage project level operational aspects of clinical studies including management of trial timelines, outsourcing strategy and Contract Research Organization (CRO) selection management, resources and vendors. The CTM is responsible for providing the study team and the Director of Clinical Operations with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation. The CTM will lead the study startup process, including but not limited to conduct of the CRO selection process, trial kick-off meeting, the set-up of the trial master file (TMF), participate in trial site selection, finalization of site and vendor Clinical Trial Agreements and budgets.
- BA/BS/BSN in related life sciences field with prior experience managing oncology trials. Advanced degree preferred
- 5+ years of progressive clinical operations experience in pharmaceutical/drug development, with a preference for immunotherapy/cellular therapy experience and at least 3 years as a trial manager
- Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
- Demonstrated effective planning, including risk assessment, contingency planning and ability to prioritize
- Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors
- Track record of working successfully in a cross-functional team
- 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
- Full training in Good Clinical Practice (GCP) guidelines and thorough knowledge of FDA guidelines
- Strong verbal and written communication skills
- 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
PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.