Clinical Biosampling Operations Leader
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.
PACT is seeking a Clinical Biosampling Operations Leader (CBOL) to develop, drive and manage the biosampling activities required for manufacturing and monitoring of PACT’s therapeutic product. The CBOL will implement the strategy across clinical stage programs while working collaboratively with a large cross functional team. In this role the CBOL will liaise with investigative site staff, external assay laboratories, collaboration partners and CROs. The CBOL will be involved in site evaluations, training and on-going assessment of clinical trial centers. Program(s) goals, milestones and deliverables are achieved via a close interaction and collaboration with all functional lines involved in clinical development and manufacturing.
The CBOL will have 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. As the program grows the Biosampling Operations Leader will be responsible for managing a growing team and contributing to the commercialization strategy.
The candidate should enjoy operating in an exceptionally dynamic and cooperative environment.
- PhD in related life sciences field with prior experience managing biosampling/biomarkers for early stage oncology trials. Project management certification is desirable
- 5+ years of progressive biosampling/biomarker experience in pharmaceutical/drug development, with a preference for cellular/gene therapy experience. Knowledge of apheresis and good tissue practices a plus
- Proven ability to influence effectively and confidently within a highly matrixed environment
- 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 assay development
- Strong analytical, problem-solving and critical thinking skills
- Demonstrated ability to earn the trust of stakeholders, team members and management
- Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
- 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
- Willingness to travel domestically
- Prior experience working in cellular therapy, personalized gene therapy, or stem cell transplant programs
- Prior experience in a hands-on early development role building out a group 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.